Introducing a complete regimen for seborrheic dermatitis
Transcription
Introducing a complete regimen for seborrheic dermatitis
New Promiseb Complete TM Introducing a complete regimen for seborrheic dermatitis • Includes new Promiseb PlusTM Scalp Wash – Can be used on the scalp or body – Fragrance free and cosmetically elegant – Massage gently upon application to loosen and wash away flakes • Promiseb Complete Trial and Savings Program – Initial prescription of Promiseb Complete filled at no cost for eligible patients* – Eligible patients will receive up to 5 refills for no more than $20 each *For a summary of all eligibility requirements please see back of rebate card available at www.promiseb.com Promiseb® Topical Cream is a nonsteroidal prescription cream indicated to manage and relieve the signs and symptoms of seborrheic dermatitis such as scaling, erythema, pruritus, and pain. Promiseb Topical Cream is contraindicated in persons with a known hypersensitivity to any component of the formulation. Promiseb Topical Cream does not contain milk, wheat, peanut, or animal derivatives. Promiseb Topical Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oil should consult their physician before using this topical preparation. Please see accompanying important safety information and full prescribing information. The use of Promiseb Plus Scalp Wash is contraindicated for patients with a history of hypersensitivity to any of the ingredients. For more information, please visit www.Promiseb.com. Promiseb is a registered trademark of Promius Pharma, LLC. ©2012 Promius Pharma, LLC. All rights reserved. PSC-0412-081 For Topical Dermatological Use Only For External Use Only Rx only Product Description: Promiseb® Topical Cream is an off-white, steroid-free, fragrance-free, water-based emulsion. Indications for Use: Under the supervision of a healthcare professional, Promiseb Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Promiseb Topical Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Directions for Use: Apply Promiseb Topical Cream to the affected skin areas 2 to 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover Promiseb Topical Cream with a dressing of choice. Ingredients: Promiseb Topical Cream is comprised of Purified Water, Isohexadecane, Butyrospermum parkii, Pentylene glycol, Ethylhexyl palmitate, Cera alba, PEG-30 Dipolyhydroxystearate, Bisabolol, Polyglyceryl-6 polyricinoleate, Tocopheryl acetate, Hydrogenated castor oil, Acifructol complex, Butylene glycol, Magnesium sulfate, Piroctone olamine, Allantoin, Magnesium stearate, Disodium EDTA, Vitis vinifera, Ascorbyl tetraisopalmitate, Glycyrrhetinic acid, Propyl gallate, and Telmesteine. Caution: The use of Promiseb Topical Cream is contraindicated in any patient with a known history of hypersensitivity to any of the ingredients. Promiseb Topical Cream does not contain milk, wheat, peanut or animal derivatives. Promiseb Topical Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oils should consult their physician before using this topical preparation. How Supplied: 30 g tube, 67857-803-30 To Open: Puncture seal with pointed end of cap. Important: The opening of this product is covered by a metal seal. Do not use if seal has been punctured or is not visible. Store at controlled room temperature 68° to 77°F (20° to 25°C), excursions permitted between 59° and 86°F (15° and 30°C). Distributed by Promius Pharma, LLC, Bridgewater, NJ 08807 Made in Italy Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. R 0209 150-210 ® Dermatology Times® Leading News and Analysis for Today’s Dermatologists facebook.com/dermatologytimes DermatologyTimes.com twitter.com/dermatologytimes inside: May 2012 teledermatology broadens access to derms’ expertise; still, barriers remain May 2012 | Vol. 33, No. 5 clinical dermatology 26 Careful laser selection, combos standard for vascular treatment cosmetic dermatology 49 Gene-matched cosmetics: Mostly hype, or practical? Volume 33 No. 5 practice mangement 56 Superior customer service generates satisfied patients special report Leading News and Analysis for Today’s Dermatologists skin 39 CanCer Fine tuning Diagnosis DermatologyTimes.com DistanCe Driven by improving technology as well as undeniable need, teledermatology continues to gain as a consultation option By Lisette Hilton Staff Correspondent National report — Teledermatology just got a boost: A new study shows that “remote viewing” by skincare specialists improves the accuracy of dermatologic diagnoses in the primary care setting by almost 70 percent. Some doctors predict this approach will become an important part of virtual healthcare in the future, offering increased access to the specialty, lower costs, and flexibility and added income for the practitioner. “I think there is really no argument if you talk to the experts in healthcare reform that virtual health is going to have to be part of the equation,” says Hon Pak, M.D., chief executive officer of the mobile technology company Diversinet of Irving, Texas. Still, many challenges — chief among them, reimbursement — remain for the incorporation of this practice into mainstream medicine, experts say. Distant diagnosing: Reimbursement a hurdle See page 20 IL-17 inhibitors may modify approach to psoriasis By Paula Moyer Staff Correspondent International report — Two experimental psoriasis drugs that target the interleu k in (IL)-17 signa ling pathway led to significant improvements in skin lesions for most patients over 12 week s, separate phase 2 studies show. Inhibiting IL-17 may be an effective approach for managing psoriasis with fewer of the immunosuppressive effects seen with current biologic therapies, results indicate. Patients showed marked improvements after treatment with the human monoclona l a nt ib ody brod alumab (Amgen) a nd t he humanized IgG4 monoclonal antibody ixekizumab (Eli Li l ly), according to Fine tuning See page 24 magenta cyan yellow black dt0512_cv2.pgs 04.25.2012 17:29 ADVANSTAR_PDF/X-1a FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Brief Summary Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing information provided with the product and therefore should not be used as the basis for prescribing the product. This summary has been prepared by deleting information from the complete prescribing information such as certain text, tables, and references. The physician should be thoroughly familiar with the complete prescribing information before prescribing the product. INDICATIONS AND USAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established. CONTRAINDICATIONS: This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. PRECAUTIONS: General: • The skin of certain individuals may become excessively dry, red, swollen, or blistered. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Excessive skin dryness may also be experienced; if so, use of an appropriate emollient during the day may be helpful. • Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products (SPF 15) and protective clothing over treated areas are recommended when exposure cannot be avoided. • Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. • Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. • Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition. Information for Patients: A Patient Information Leaflet has been prepared and is included with each package of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. It also is advisable to allow the effects of such preparations to subside before use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is begun. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of these clinical formulations (0.04% and 0.1%). A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are two and four times the maximum human systemic dose applied topically, when normalized for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, normalized for total body surface area). For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose applied topically is defined as 1 gram of Retin-A Micro (tretinoin gel) microsphere, 0.1% applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight). Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel) microsphere, 0.04% or 0.1%. Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative. The components of the microspheres have shown potential for genetic toxicity and teratogenesis. EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, the HGPRT forward mutation assay, and the mouse micronucleus assay. In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the maximum human systemic dose applied topically, and normalized for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose applied topically and normalized for total body surface area) and above were observed. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (17 times the human topical dose normalized for total body surface area). Dermal fertility and perinatal development studies with Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, have not been performed in any species. Pregnancy: Teratogenic Effects: Pregnancy Category C. In a study of pregnant rats treated with topical application of Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.5 to 1 mg/kg/day on gestation days 6-15 (4 to 8 times the maximum human systemic dose of tretinoin normalized for total body surface area after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%) some alterations were seen in vertebrae and ribs of offspring. In another study, pregnant New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. There appeared to be increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, at 0.5 and 1.0 mg/kg/day. Similar malformations were not observed at 0.2 mg/kg/day, 3 times the maximum human systemic dose of tretinoin after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area. In a repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin exposure were seen. Other pregnant rabbits exposed topically for six hours to 0.5 or 0.1 mg/ kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any teratogenic effects at doses up to 17 times (1.0 mg/kg/day) the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface area, but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin in non Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits when given in doses of 42 and 27 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively, (assuming a 50 kg adult applied a daily dose of 1.0 g of 0.1% gel topically). At these topical doses, however, delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is more similar to humans than other species in its handling of tretinoin, fetal malformations were reported for doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose normalized for total body surface area), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of Retin-A. Although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known. Non-Teratogenic Effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose applied topically and normalized for total body surface area), resulting in fetal resorptions and variations in ossification. Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (21 times the maximum human systemic dose applied topically and normalized for total body surface area). There are, however no adequate and well-controlled studies in pregnant women. Animal Toxicity Studies: In male mice treated topically with Retin-A Micro (tretinoin gel) microsphere 0.1%, at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area) for 90 days, a reduction in testicular weight, but with no pathological changes were observed at the two highest doses. Similarly, in female mice there was a reduction in ovarian weights, but without any underlying pathological changes, at 5.0 mg/kg/day (21 times the maximum human dose). In this study there was a dose-related increase in the plasma concentration of tretinoin 4 hours after the first dose. A separate toxicokinetic study in mice indicates that systemic exposure is greater after topical application to unrestrained animals than to restrained animals, suggesting that the systemic toxicity observed is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or 25 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively) for 90 days showed no evidence of reduced testicular or ovarian weights or pathological changes. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established. Geriatric Use: Safety and effectiveness in a geriatric population have not been established. Clinical studies of Retin-A Micro did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. ADVERSE REACTIONS: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. OVERDOSAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is intended for topical use only. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. Rx only. Distributed by: Ortho Dermatologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Los Angeles, CA 90045 © OMP 2011 11DD0126 07/11 RETIN-A MICRO ® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. MICROSPONGE ® is a registered trademark of AMCOL International Corporation. 4 ® Dermatology Times | publishing & sales Leading News and Analysis for Today’s Dermatologists MAY 2012 } VOL. 33, NO. 5 our mission Dermatology Times is the only clinical news resource serving a readership of more than 14,000 dermatologists and other professionals focused on skin care. Through unbiased reporting, we strive to help practitioners put into perspective developments that affect their business. 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Library Access Libraries offer online access to current and back issues of Dermatology Times through the EBSCO host databases. To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477. Cover credit: Getty Images: Tablet computer: Yagi Studio/Photodisc; Skin cancer: DR P. MARAZZI/SPL Science Photo Library; Young girl: Zero Creatives/Cultura PRINTED IN U.S.A. There’s a community we’ve supported for years. They’re called dermatologists. At Bayer HealthCare, we don’t just support patients. We also support the people who care for them. We’ve developed dermatologic treatments to meet your needs—and we’re building a pipeline to meet your needs in the future. We support the societies and foundations that advance your specialty. We educate your patients and provide them greater access to treatment. At Bayer HealthCare, we have a passion for dermatology—and support all of the people who practice it. Visit us at dermatology.bayerus.com or call 1-866-463-3634. A Passion for Dermatology Models used for illustrative purposes only. © 2012 Bayer HealthCare Inc. Bayer and the Bayer Cross are registered trademarks of Bayer HealthCare Inc. All rights reserved. 100-10-0001-12 April 2012. Printed in USA. 6 Editorial Advisory Board Update Dermatology Times | May 2012 insight & opinion from our advisory board leaders Norman Levine, M.D., is a private practitioner in Tucson, Ariz. Trust factors How can you determine the validity and accuracy of today’s published research? I n my early years in dermatology, there were many distinguished and acknowledged experts whose published findings became part of the core of the discipline. When they presented their findings at medical meetings or in print, one assumed that the data was valid and accurate, and it was often translated into specific management options for our patients. If future findings failed to support, or if they actually refuted, these findings, it was understood that science is a dynamic process in which improvements in research methods, technology and evaluation of data inevitably lead to advances, often at the expense of what was previously considered to the “conventional wisdom.” In fact, one of my medical school professors claimed that 50 percent of what we would learn in school would subsequently be proven false. He was probably fairly accurate in his prediction. The giants of dermatology have largely passed from the scene, and a new generation of real authorities has not yet stepped forward. With few exceptions, we seldom questioned the intellectual integrity of the researching dermatologists, many of whom were supported by government grants or institutional funding. Although there may have been some industry money involved in research efforts, one did not get the impression that the work was being overly influenced by those who supported it financially. Rarely was one left with the impression that there was intentional bias in the published reports. Times have changed. We are now in the era of speakers bureaus, “thought leaders,” hired guns with nominal academic credentials, and ghostwritten research articles originating from the offices of the pharmaceutical industry. The giants of dermatology have largely passed from the scene, and a new generation of real authorities has not yet stepped forward. The truly independent clinical researcher is harder to identify, since many academic dermatologists have consulting agreements with industry. Does this compromise their independence and standing in the academic community? In my opinion, the answer is yes. Sorting it out There are scientific advances being reported almost daily. How can we determine what is legitimate and what may be over-hyped, biased information? If we can’t trust the “experts,” can we rely on the opinions of bloggers or those who contribute to online chat groups? Can we rely on those who critically review the work of others? Although admittedly over-simplified, the following is a guide to the evaluation of what you read and hear: ▶ Do not trust data reported by investigators under contract to entities with a vested interest in the outcome of the work. I will often avoid reading any article in which one or more of the authors is an employee of a company specifically interested in the product or technology being discussed. Even if the data is valid, the manuscripts are often written with the intent of promoting a point of view rather than giving a balanced discussion of the data. ▶ Never take at face value information presented at dinner meetings or similar events by an individual who is a member of a speakers bureau, and hence usually sponsored by industry. I do not care how insistent the claim is made that the speaker is free to say what he pleases about the subject being discussed. I can assure you that the sponsor will not tolerate negative comments about its products. ▶ Online chat groups are a nice way to communicate with colleagues. However, the information is totally unfiltered, notoriously anecdotal in nature, and often unreliable. Be careful before deciding on management options based on the comments in these forums. ▶ You are reading this editorial in a news magazine and thus have some inclination that this form of communication is valuable to you. Many of the articles represent the work of skilled reporters. However, these reporters must rely on the veracity and knowledge of others who may have an agenda to be promoted. Be wary of this information and try to find other published documents to support the claims of these individuals. ▶ There are several excellent dermatology journals, and there are numerous ones of lesser quality. Good editors make a difference in what gets published. I tend to trust articles published in Journal of Investigative Dermatology, Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology over others in our specialty. ▶ There are publications that review and comment on published articles in the dermatology literature. I find these extremely valuable resources since the reviewers are well informed and are completely unbiased in their opinions. Two such publications are Journal Watch and DermClips. There’s voluminous new information appearing in the rapidly changing scientific community, but we must avoid the pitfall of believing everything that we read or hear. DT Norman Levine, M.D. Questions? Comments? Email the editor at [email protected]. aquapharm.com MAD-1102 8 legal eagle Dermatology Times | May 2012 David Goldberg, M.D., J.D., is director of Skin Laser & Surgery Specialists of New York and New Jersey; director of laser research, Mount Sinai School of Medicine; and adjunct professor of law, Fordham Law School. Conflict resolution When the board of nursing and board of medical examiners disagree, who wins? D r. Laser has a large cosmetic dermatology practice in a highly regulated state. As a general rule, he and his fellow physicians perform most of the laser procedures in his office. With the onset of the recession, however, many of his patients are no longer able to afford his office fees. In an attempt to lower his fees, Dr. Laser spent an enormous amount of time teaching his nurses to use lasers for various problems such as hair removal, facial toning and acne treatment. In several states, there are even conflicts between the board of nursing (with jurisdiction over nurses) and the board of medicine (with jurisdiction over physicians). Dr. Laser sent his staff to many training courses and established rigid in-office guidelines for laser treatments. Not only did the staff become expert at treatment protocols, they also became adept at providing expert informed consent and lessening the incidence of complications. Dr. Laser was comfortable that his nonphysician providers were as good as, or better than, some physicians performing similar treatments. Unfortunately, one of Dr. Laser’s patients who was treated by a laser nurse (without any physician present at the time of the incident) now has a scar on her upper lip. The patient was given appropriate consent, and the utilized technique was appropriate. The patient, however, immediately sought legal counsel. The plaintiff patient’s attorney had the medical records evaluated by two experts in the field, and no breach in the standard of care could be found. No negligence was present. No lawsuit was filed in court. Not being satisfied, the patient filed a complaint against the nurse and Dr. Laser with the state board of nursing. The substance of her complaint was that a nurse can never be as “good” as a physician, and therefore, Dr. Laser and his nurse should be sanctioned. Of course, the board of nursing has no jurisdiction over Dr. Laser, who like all physicians was licensed by and comes under the jurisdiction of his state board of medical examiners. The state board of nursing has administrative regulations that allow nurses to perform laser treatments. Dr. Lasers’ nurse is not sanctioned by the state board of nursing. The aggrieved plaintiff patient then filed a complaint against Dr. Laser with his state board of medical examiners. Her contention was that treatment in a medical office is the practice of medicine and therefore cannot be delegated to a nurse. She sought sanctions against Dr. Laser. The state board administrative regulations do state that laser treatment is considered the practice of medicine; however, the regulations do not specifically address the delegation of treatment to nurses. The aggrieved plaintiff wants Dr. Laser’s license revoked. Should Dr. Laser be worried? Eye on Kentucky There is no easy answer to this issue. Regulations vary from state to state. In several states, there are even conflicts between the board of nursing (with jurisdiction over nurses) and the board of medicine (with jurisdiction over physicians). Kentucky is one such example. Kentucky’s legislature has enacted statutes that define both the practice of medicine and the practice of nursing. The statutes are completely silent with respect to cosmetic laser procedures. This silence creates a problem. The statute’s silence means that both the medical and nursing boards have leeway in interpreting the law for themselves. The Kentucky Board of Medical Licensure asserts that the ultimate supervisor for laser procedures must be a physician; the nursing board disagrees and says that an advanced registered nurse can also supervise such procedures. In addition, the Kentucky Medical Board adopted a position statement holding that all laser procedures, including laser hair removal and intense pulsed light, constitute the practice of medicine and must therefore be performed only under the supervision of a physician. In 2004, the Kentucky Medical Board, in request to a request for an opinion on laser hair removal by nurses, stated that the procedure was within the scope of nursing practice but that the Medical Board would require nurses to have medical supervision. Meanwhile, Kentucky’s nursing board published a 2008 advisory opinion in which it stated that laser treatments, including nonablative lasers, laser skin resurfacing, intense pulsed light and laser hair removal, are all included within the scope of nursing practice. The confusion between the medical board and nursing board in this state and others becomes obvious. Unfortunately, depending on his jurisdictional rules, Dr. Laser may need to hire his own health law attorney to sort out the issues in this case. DT Pacific Bioscience Laboratories, Inc. © 2012 Pacific Bioscience Laboratories, Inc. Clarisonic is a registered trademark and Mia 2 is a trademark of You’ve always recommended thorough daily cleansing to your patients. Now there’s an easy way to help them comply. Introducing the Clarisonic®Acne Clarifying Collection, a gentle yet powerful, one-step cleansing regimen that pairs the patented sonic technology of the Mia 2™ with our Acne Cleansing brush head and our Acne Daily Clarifying Cleanser. MIA 2 Offering 2 speeds, including a low speed, the Mia 2 is gentle enough to use twice a day, even on sensitive, compromised skin. And because it cleanses 6X better than manual cleansing, it removes the impurities from pores to allow skin care products to be absorbed more effectively. ACNE CLEANSING BRUSH HEAD Gentle for use on acne-prone skin with extra-plush bristle gradation, the velvet-like bristle tips of our Acne Cleansing brush head deliver concentrated flushing of the pores to provide an ultra-gentle cleansing action. ACNE DAILY CLARIFYING CLEANSER WITH SALICYLIC ACID Our Acne Daily Clarifying Cleanser is specially formulated with 2% salicylic acid to help keep skin clear and prevent new blemishes from forming. It’s also enriched with beneficial vitamins and botanicals to help reduce the appearance of redness. To learn more about the Acne Clarifying Collection, please call 877.825.9633. clarisonic.com/professional on call 10 Dermatology Times | May 2012 Karen Nash, a print and broadcast media medical reporter and former TV medical news reporter, has been writing On Call for more than 20 years. Contact her at [email protected]. Bracing for change Uncertain future for healthcare prompts derms to expand, adjust services A fter a two-month extension, Congress, once again, postponed scheduled Medicare reimbursement cuts, at least until the end of the year. The Affordable Care Act ended up before the U.S. Supreme Court with the ruling on its constitutionality — either in total or in part — expected in June. “After three years of trying to lean out the practice, I think it’s matured to the point where we don’t want to become any more lean in terms of office staff.” Christopher Dannaker, D.O. University of California, San Francisco Dr. Wray What’s more, November’s presidential and congressional elections could change the direction of the country. On Call asked dermatologists around the country what they, or their practices, are planning this year as they await a determination of what healthcare delivery will look like. Are they making any major changes, expanding or downsizing their practices? Adam Wray, D.O., is a hospitalemployed dermatologist in Blackfoot, Idaho. He says the hospital is positioned fairly well at this point and isn’t planning any major moves. “I think everybody’s concerned about expanding; nobody’s really optimistic about what the future holds, both for healthcare and the economy, in general. We’re just taking a wait-and-see approach. “The advantage we have is that it’s a critical access hospital. Whether it’s real or just perceived, I think there is some protection from major changes in the healthcare system, because of the hospital being critical access for Medicare,” he says. In practice for five years and on the clinical faculty for Pacific Northwest University and Idaho State, Dr. Wray says that at this point in his career, it’s nice to have that kind of security. “Had I not been married and had kids, I possibly would have gone out on my own. The challenge of running a practice is something that interests me, but when you have medical school loans to pay off, and mouths to feed, that security is important.” Out-of-pocket only In Monterey, Calif., Christopher Dannaker, D.O., has positioned himself so he is insulated from what the government will do about healthcare. Seven years ago he transitioned to a totally cosmetic practice, and he doesn’t accept Medicare or any other insurance. “I opted out of Medicare so as not to create any positive dissonance between a patient receiving treatment then trying to file for Medicare. By opting out, we can perform cosmetic services without concern about whether or not Medicare would deem it to be noncosmetic.” Dr. Dannaker, assistant professor at the University of California, San Francisco, thinks his practice may have seen some of its more difficult times in the past few years. “Cosmetic dermatologists did get hit when the economy fell. I also faced another difficulty because new competition developed around here from noncore specialists, and even RNs. “But over the last couple of years, despite the economic recession, our business started to pick up because many patients who had services from those paramedical and noncore specialists have become dissatisfied, at least in our small community. Therefore, after a few years, they’ve actually came back to our practice.” Dr. Dannaker says he thinks he is well prepared for what comes next because of actions he’s taken over the past few years. “After three years of trying to lean out the practice, I think it’s matured to the point where we don’t want to become any more lean in terms of office staff. My economizing moves have probably already occurred. “Now we are looking at the acquisition of new capital equipment very carefully. We don’t try to amortize our costs over a long period, even five-year leases. We want that technology to pay for itself in a much shorter lifespan, because we can’t be fully confident of what patient desires for that technology will be in the future,” Dr. Dannaker says. A decision to sell older equipment shortly before the economy tanked worked out well for Dr. Dannaker’s practice, he says. “I’m a solo practitioner with seven lasers, so I do have a lot of technology. I made my purchases before the economic downturn. Then, at the beginning of the downturn, I purged and sold all of my older lasers that I felt were redundant or not as useful. If I had waited, those would be unsellable now,” he says. Expanding operations Other dermatologists are taking an active approach to this year’s instability. In Bluffton, S.C., Carmen Traywick, M.D., in practice for less than three years, recently bought another solo practice. “We had been discussing it for a year and a half, but didn’t want to commit because of the uncertainty. We were going back and forth. We’ve needed to expand for a while but the uncertainty held things up. We finally ended up buying the practice assets and joining with the other dermatologist. We kind of had to do it now because the other dermatologist didn’t want to take on converting to electronic medical records (EMRs) and wanted to slow down a bit. We May 2012 | DermatologyTimes.com already had EMR, and it was such a great opportunity, we couldn’t let it pass,” Dr. Traywick says. The decision by Congress to yet again delay Medicare reimbursement cuts gave Dr. Traywick some financial Dr. Traywick breathing room, she says. “When the Medicare cuts were postponed again, we knew we would have this year to start paying things off. It’s a good move,” Dr. Traywick says. “Ideally I would like to build a bigger office and actually own the building, but at least this is bridging the gap so I have more space. It’s a little baby step.” Despite wanting to expand, Dr. Traywick says she probably wouldn’t have taken the step were not for one other factor. “I wouldn’t be here except for the fact my husband handles all the business. He really wanted to open a business. This way, if he’s opening a business and working long hours, at least it’s benefiting both of us instead of some other company,” she says. Meeting a need In Cape Girardeau, Mo., solo practitioner Charles Moon, M.D., is also expanding this year. “I just purchased land, and I’m starting the design and building process on a new building. I’m looking not only to expand the physical facility, but also our numbers,” he says. Whatever happens on a national, or local basis, Dr. Moon says he also believes this was something that he had to do. “I think dermatology is always going to be in demand, Dr. Moon regardless of how the healthcare market fares. Right now there’s a lot of fat that could be trimmed, and we would still do OK. I’m saving as much as I can.” Growing his practice will allow Dr. Moon to operate more efficiently and to address a demand for cosmetic services, he says. “By expanding a little bit, I can be more efficient. I’m less efficient in my space now because it’s too small. It limits me in adding ancillary services. By growing, I can control my overhead better by having a partner and having the space for a partner. I plan to expand services into the cosmetic area, because I’m limited there also.” In practice for nine years, Dr. Moon spent several years in the military, one in a group practice, and 2 1/2 years solo. “My area is really underserved. There’s a big demand for cosmetic services that hasn’t been filled. We have a few plastic surgeons to do invasive procedures, but they don’t do lasers, other noninvasive procedures, or product lines, so there is room to develop. The key is to develop ancillary services. “If pathology gets hit, it’s not a big deal because I still do a lot of general dermatology. If general derm gets hit, OK, I do little cosmetic dermatology. If the economy dips again, I go back and do general dermatology. They are just ways to hedge a little bit,” he says. Dr. Moon says he anticipates demand for dermatologists to rise as the draw of retirement pulls more physicians away from the specialty. “Dermatologists who specialize in Mohs surgery could be the ones to worry, because I think Mohs codes are going to get whacked big time, which is a shame because it’s a great thing. If I were 55 and didn’t want to redevelop my practice, I would probably get out of medicine. I think we will see an exodus of people who can retire, will retire. So, the demand is only going to become stronger for dermatology services for the people who are practicing,” he says. DT 1Therapy 2 Steps High Clearance Low Down Time 3 Reasons to use 1* ** Physician-Controlled Therapy *At 8 weeks, 77% of patients treated with Levulan PDT experienced 75% clearance of AK lesions vs 23% of the control group. 83% of the patients treated with Levulan PDT had 75% clearance of face lesions and 60% of the patients had 75% clearance of scalp lesions. 66% of patients treated with Levulan PDT experienced 100% clearance of AK lesions vs 13% of the control group. 70% of the patients treated with Levulan PDT had 100% clearance of face lesions and 55% of the patients had 100% clearance of scalp lesions. Important Risk Information The Levulan® Kerastick® for Topical Solution plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp. Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the Levulan Kerastick for Topical Solution. The most common adverse events include scaling/crusting, hypo/hyperpigmentation, itching, stinging and/or burning, erythema and edema. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during the treatment. Following treatment, the treated AKs and to some degree the surrounding skin may redden, and swelling and scaling may also occur. However, these effects are temporary and should completely resolve by 4 weeks after treatment. **Patients treated with Levulan PDT should avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. 1. Levulan® Kerastick® Prescribing Information, DUSA Pharmaceuticals, Inc.® Please see safety information on adjacent page. Levulan®, Kerastick® and BLU-U® are registered trademarks of DUSA Pharmaceuticals, Inc.® www.levulan.com MKT-1665AW Rev A 14 Dermatology Times | May 2012 research stat abstracts from that pile of peer-reviewed journals on your desk Clinical Dermatology ◾ Dual moDe laser effective for acne vulgaris treatment Journal of the american academy of Dermatology april 2012 A dual mode 1,064 nm Nd:YAG laser rapidly and effectively treats acne vulgaris, according to a study published in the April issue of the Journal of the American Academy of Dermatology. Researchers with Seoul National University College of Medicine, South Korea, reviewed the results of 22 patients who received three sessions of quasilong pulse and Q-switched Nd:YAG laser treatments. The treatments were assisted with topically applied carbon suspension at two-week intervals in a randomized, split-face manner. On the laser-treated side, inflammatory acne lesions were reduced by 58.6 percent, but they were increased on the nontreated side by 5 percent, investigators found. Noninflammatory acne lesions were reduced by 52.4 percent on the treated side. Patients reported mild transient erythema that disappeared within a few hours, but no severe adverse reactions were reported. “The histopathologic findings correlated well with the clinical acne grade and treatment response. This novel laser treatment appears to be safe and effective for acne treatment,” the study authors wrote. http://www.eblue.org/article/S01909622(11)01012-7/abstract ◾ Psoriasis theraPies’ effectiveness variable archives of Dermatology april 2012 The use of psoriasis therapies in clinical practice may not be as effective as what has been reported in previous trials, according to a report published in the April issue of Archives of Dermatology. Researchers with University of Pennsylvania Perelman School of Medicine, Philadelphia, compared the effectiveness of biologic systemic therapy, nonbiologic systemic therapy and phototherapy to treat psoriasis in 713 patients. The proportion of patients achieving clear or almost clear ratings on the Physician Global Assessment scale was 23.8 percent for methotrexate, 47.7 percent for adalimumab, 34.2 percent for etanercept, 36.1 percent for ustekinumab and 27.6 percent for narrowband UVB. In adjusted analyses, investigators found, patients who received adalimumab, etanercept and ustekinumab were more likely to have clear or almost clear skin, versus patients receiving methotrexate. Patients who received phototherapy demonstrated no significant difference compared to those who received methotrexate. “Although relative differences in objective response rates among therapies may exist, absolute differences are small and may not be clinically significant. Dosing of common therapies varied from trial recommendations,” the study authors wrote. “These results provide novel benchmarks emphasizing the critical importance of studying effectiveness in real-world practice.” http://archderm.ama-assn.org/cgi/content/abstract/148/4/487 ◾ methotrexate, azathioPrine equally effective for eczema british Journal of Dermatology april 2012 Azathioprine and methotrexate may be equally effective and safe for short-term treatment of severe atopic eczema, according to a critical appraisal published in the April issue of the British Journal of Dermatology. The appraisal examined a study conducted by researchers with University of Amsterdam, who sought to compare the efficacy and safety of methotrexate with azathioprine in 42 adult patients with severe atopic eczema. The single-blind, parallel-group, randomized controlled trial was conducted in a secondary care setting in the Netherlands from July 2009 to December 2010. Patients with severe atopic eczema were randomly assigned in a 1:1 ratio to receive methotrexate at doses of 10 mg to 22.5 mg weekly, or azathioprine 1.5 mg/kg to 2.5 mg/kg-1 daily for 12 weeks, followed by 12 weeks of followup. The primary outcome was the mean change in the SCORing of Atopic Dermatitis index (SCORAD). At week 12, patients taking methotrexate had a relative reduction in SCORAD of 42 ± 18 percent compared to 39 ± 25 percent in the azathioprine group. The proportions of patients achieving at least mild disease and reductions in impact on quality of life and symptoms were similar for both groups at weeks 12 and 24, researchers found. No serious adverse events were reported in either group. http://onlinelibrary.wiley.com/doi/10.1111/ j.1365-2133.2012.10872.x/abstract ◾ S. aureuS iDentifieD in Patients with atoPic keratoconJunctivitis allergy april 2012 Staphylococcus aureus (S. aureus) and S. aureus-secreted enterotoxins (SE) are often found in patients who have atopic keratoconjunctivitis (AKC), according to a study published online April 10 in Allergy. Investigators with Tsurumi University School of Dental Medicine, Yokohama, Japan, studied 18 patients with AKC, nine patients with vernal keratoconjunctivitis (VKC), eight with seasonal allergic conjunctivitis (SAC) and 10 healthy volunteers. The researchers performed slit lamp examinations and collected scraped samples from the upper tarsal conjunctiva, lower conjunctival sacs and the skin around the eyelid margins. S. aureus was significantly more prevalent in patients with AKC than with VKC, SAC and the healthy volunteers. Superantigen genes (SAg) were found in 11 patients. In severe types of ocular allergic disease such as AKC and VKC, SE was detected in six of 10 patients with corneal ulcers and in two of 17 patients without the ulcers, the researchers determined. “In patients with AKC, S. aureus and SE were detected more frequently compared with other patients and healthy volunteers, especially in association with corneal ulceration suggesting a role of SE,” the study authors concluded. “So far, it is unknown whether SE leads to tissue damage of the cornea by initiating an immune response or has direct toxic effects.” http://onlinelibrary.wiley.com/doi/10.1111/ j.1398-9995.2012.02818.x/abstract Skin Cancer ◾ activities, smoking imPact lymPh noDe role in melanoma Journal of the american academy of Dermatology february 2012 Smoking habits, sports activities and physical workload impact the sonomorphologic aspects of peripheral lymph nodes (LNs) in patients with cutaneous melanoma, according to a study published in the February issue of the Journal of the American Academy of Dermatology. Investigators with the University of Bonn, Germany, conducted a prospective study of 200 patients with a history of invasive cutaneous melanoma to analyze the influence of sporting activity, physical workload, smoking habits, infections of the upper respiratory tract and interferon alfa therapy on the number and morphology of LNs, which were examined with high-resolution ultrasound. During follow-up visits for melanoma, patients underwent ultrasound exams of cervical, axillary and inguinal LN regions. Patients active in sports were found to have more LNs in inguinal regions, a higher volume and a larger LN diameter. Patients with hard physical workloads in their occupations had significantly higher volume of the biggest LN. Compared with nonsmoking patients, smokers had higher values in the total quantity of LNs, in the greatest volume of LN, and in the greatest diameter of LN in the cervical regions. Other factors had no significant influence on the LN parameters, investigators found. Study authors noted the study population was too small to comment on influencing factors in more detail, “especially the influences of different sporting activities or smoking habits.” http://www.eblue.org/article/S01909622(12)00124-7/abstract ◾ immune Pathway inhibition may trigger melanoma growth science translational medicine march 2012 Melanocyte expression of an immune inhibitory molecule may be associated with the presence of tumor-infiltrating lymphocytes, according to a study published in March in Science Translational Medicine. Researchers at Johns Hopkins Medical Institutions, Baltimore, seeking to determine the association between immune inhibitory molecule B7-H1 and tumor-infiltrating lymphocytes (TILs), examined the expression of the molecule in melanocytes and in primary and metastatic melanomas. Of the B7-H1-positive tumors, 98 percent were associated with TILs, while 28 percent of B7-H1-negative tumors were associated with the lymphocytes. The investigators discovered B7-H1-positive melanocytes were “almost always” localized immediately adjacent to TILs. Interferon-gamma, a primary inducer of B7-H1 expression, was detected at the interface of B7-H1-positive tumors and TILS, while none was found in B7-H1negative tumors. “Therefore, TILs may actually trigger their own inhibition by secreting cytokines that drive tumor B7-H1 expression,” the study authors noted. Patients with B7-H1positive metastatic melanoma survived significantly longer than patients with B7-H1-negative metastatic melanoma, researchers determined. “Induction of the B70-H1/PD-1 pathway may represent an adaptive immune resistance mechanism exerted by tumor cells in response to endogenous antitumor activity and may explain how melanomas escape immune destruction despite endogenous antitumor immune responses,” the authors wrote. http://stm.sciencemag.org/ content/4/127/127ra37 ◾ basal cell carcinoma on ear significantly more aggressive Journal of the american academy of Dermatology may 2012 Basal cell carcinoma (BCC) on the ear is more likely to be aggressive and is more frequently found in men than in women, according to a study published in the May issue of the Journal of the American Academy of Dermatology. Researchers at the University of California, San Francisco, analyzed a 2009 database for all BCCs biopsied from the ear. They reviewed data points including tumor subtype and risk level for 100 BCCs on the ear and 100 on the cheek. BCC on the ear was diagnosed 471 times, and 57 percent were high risk compared with 38 percent on the cheek, investigators found. Men were more likely to have BCC on the ear, at 79 percent compared to 53 percent on the cheek. BCC on the ear in women was also more likely to be aggressive, at 57 percent. “BCC on the ear presents as an aggressive phenotype in the majority of cases for both men and women, and it occurs much more frequently in men,” the authors wrote. “Knowledge of this information can help guide physicians and ensure that these tumors are adequately biopsied and treated.” The study authors noted the data was retrieved during a single year at the institution, and there could be potential regional bias. Additionally, many of the specimens were reviewed in consultation and could therefore represent a selected bias, they wrote. http://www.eblue.org/article/S01909622(11)00595-0/abstract 16 washington & you Dermatology Times | May 2012 Bob Gatty, former congressional aide, covers Washington for businesses specializing in healthcare and related issues. Contact him at [email protected]. Pushing for repeal Physician groups, House Republicans aim to strike down IPAB R epublicans apparently have given themselves an important and potentially emotional campaign issue designed to appeal both to those on Medicare and the physicians who treat them come the November election. On March 22, the GOPcontrolled U.S. House of Representatives voted to repeal the controversial Independent Payment Advisory Board (IPAB). On March 22, the GOP-controlled U.S. House of Representatives voted to repeal the controversial Independent Payment Advisory Board (IPAB), established by the new healthcare law now being challenged in the U.S. Supreme Court, and intended to provide a mechanism to control increasing Medicare costs. That, of course, has been sought by large numbers of physicians groups, including the American Academy of Dermatology Association, which see the IPAB as an unfettered entity whose purpose will be to slash Medicare reimbursement rates for procedures and services in order to reach pre-established expenditure targets. Such an action, opponents say, will ultimately lead to rationing of care. Push and pull on IPAB While Republicans in the Senate are pushing for IPAB repeal, Democrats still are in control there and are not expected to support the measure, which President Obama has promised to veto even if it should pass. The election-year strategy of House Republicans became clear when they included in the IPAB repeal legislation provisions that would limit medical malpractice awards, also an objective of the medical community, but strongly opposed by many Democratic lawmakers. While some observers speculated that IPAB repeal might be supported by enough moderate Democrats for it to squeak through the Senate, adding the malpractice caps only served to dilute that support and virtually guarantee the issue will be front and center during the fall campaign, giving them the opportunity to reprise their warning of a “death panel” making lifeand-death decisions regarding seniors. Adding to the uncertainty for physicians is the question of how the Supreme Court will rule on the challenge to the healthcare law it is now considering. Should the court rule the entire law is unconstitutional, the IPAB will be history. However, if the court upholds the law or only tosses out specific provisions, such as the requirement that individuals must purchase health insurance or pay a penalty, then the IPAB will remain. Request for repeal The AADA has urged its members to contact lawmakers urging IPAB repeal, joining other medical society members of the IPAB Coalition that have been made this a lobbying priority. “This controversial, unelected board has been granted unprecedented power to replace congressional authority should Medicare spending exceed its estimated targets,” AADA said in a prepared statement. “Like the existing flawed SGR (sustainable growth rate) formula, these target-based expenditure systems fail to contain Medicare costs and instead unfairly place the cost-saving burden on physicians.” Opponents of the IPAB make these points: ▶ In its first five years, IPAB can only recommend cuts in Medicare to physicians and a few other provider types. However, hospitals, nursing homes, and most other providers are exempt from the cuts. ▶ Cuts are capped at 0.5 percent for 2015, 1 percent for 2016, 1.25 percent for 2017 and 1.5 percent for 2018 and beyond. Only a portion of Medicare providers can be cut in the first five years, however, so they will bear a large burden. ▶ IPAB cannot recommend increasing Medicare premiums, co-pays or deductibles, and cannot recommend benefit changes or eligibility restrictions. ▶ Recommended cuts must come from within Medicare, not outside sources of revenue. ▶ IPAB’s recommendations become law each year unless Congress acts to overturn them or blocks or makes changes and identifies alternative cuts within the Medicare program. In remarks on the Senate floor the day the House approved the legislation, Sen. Tom Coburn, M.D. (R-Okla.), a colon cancer survivor, cautioned that one of the first things that would be cut by the IPAB would be the reimbursement rate for colonoscopies. What would happen when the rate for the procedure goes below costs, he asked. “What do you think is going to happen on screening?” “What the American people need to understand is what is coming about is a group of 15 unelected bureaucrats who cannot be challenged in court, who cannot be challenged on the floor of the Senate or House, mandating price reductions to control the cost of Medicare,” he said. “What does that actually mean? They will do their job. We won’t be able to do anything about it, but what it means is they will reimburse at levels less than is the cost to do services, and so consequently what will happen is the service won’t be there.” Dr. Coburn also pointed out that the IPAB will be performing “comparative effectiveness research,” which, he contended, will be used “to deny or change payments for procedures that patients need.” washington & you see page 18 Proven effective in moderate to severe acne* 1 ,2 Power Now with ease! in a ready-to-use 50g pump ● Neat and simple: No jar, no mess ● Measured dose: Consistent delivery ● Longer shelf life: 10 weeks’ stability at room temperature ● Convenience: Easily portable and meets TSA liquid carry-on limits Indication and Important Safety Information Acanya Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. Acanya Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. Discontinuation is recommended if significant diarrhea, bloody diarrhea, severe abdominal cramping, or colitis (including pseudomembranous colitis) develops. Clindamycin taken orally or through IV may result in severe colitis, which may result in death. Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide. If a patient develops symptoms of an allergic reaction such as swelling or shortness of breath, they should be instructed to discontinue use and contact a physician immediately. Patients should be advised to avoid contact with the eyes or mucous membranes and to minimize sun exposure following the application of Acanya Gel. To learn more, please visit www.AcanyaGel.com Please see brief summary of prescribing information on adjacent page. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov /medwatch, or call 1-800-FDA-1088. *Individual results may vary. References: 1. Pivotal studies, data on file, CORIA Laboratories. 2. Gold M. A new, once-daily, optimized, fixed combination of clindamycin phosphate 1.2% and lowconcentration benzoyl peroxide 2.5% gel for the treatment of moderate-to-severe acne. J Clin Aesthetic Dermatol. 2009;2(5):44-48. © 2012 Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC ACAN-0112-0001 NOW IN A PUMP 18 Dermatology Times washington & you washington & you from page 16 What’s wrong with all of this? Dr. Coburn asked. “We are inserting a government board and government bureaucrat between the patient and the doctor. Think about that for a minute. When I go to my doctor, I don’t want him concentrating about anything except me. And if he’s looking over his shoulder about whether or not he met the IPAB’s comparative effectiveness study on what he’s doing for me when, in fact, the art of medicine as well as the science may say they’re wrong, and he’s going to do what the government says rather than what he thinks is best for me. “The greatest threat for quality of care for seniors in this country is the Independent Payment Advisory Board and their noncaring position, because they’re going to be looking at numbers and words, and they’re never going to lay their hand on a patient,” he adds. “They’re never going | May 2012 to impact a patient directly. They’re never going to listen to a patient. But they’re going to make the ultimate decisions based on what that patient’s going to get.” DT EDITOR’S NOTE: Mr. Gatty welcomes dermatologists’ input about how governmental policies, or pending policies, affect their practices. If you have a specific topic you’d like him to explore in an upcoming issue, email him at ▶ [email protected]. USE IN SPECIFIC POPULATIONS Pregnancy Category C There are no well-controlled trials in pregnant women treated with ACANYA Gel. It also is not known whether ACANYA Gel can cause fetal harm when administered to a pregnant woman. ACANYA Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ACANYA® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% Brief summary. Please see full prescribing information for complete product information. INDICATIONS AND USAGE ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. The safety and efficacy of this product in the treatment of any other disorders have not been evaluated. DOSAGE AND ADMINISTRATION Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond 12 weeks has not been evaluated. Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity. Nursing Mothers: It is not known whether clindamycin is excreted in human milk after topical application of ACANYA Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ACANYA Gel while nursing, taking into account the importance of the drug to the mother. ACANYA Gel is not for oral, ophthalmic, or intravaginal use. Pediatric Use: Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated. Clinical trials of ACANYA Gel included patients 12-17 years of age. CONTRAINDICATIONS ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibioticassociated colitis. Geriatric Use Clinical studies of ACANYA Gel did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. WARNINGS AND PRECAUTIONS Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. When significant diarrhea occurs, ACANYA Gel should be discontinued. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity and impairment of fertility testing of ACANYA Gel have not been performed. Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death. Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fl uids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis. Ultraviolet Light and Environmental Exposure Minimize sun exposure following drug application. (See NONCLINICAL TOXICOLOGY.) ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates. The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, patients were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of patients that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown below. Local Skin Reactions—Percent Patients with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773) Erythema Scaling Itching Burning Stinging Before Treatment (Baseline) Mild Mod* Severe 22 4 0 8 <1 0 10 2 0 3 <1 0 2 <1 0 Maximum During Treatment Mild Mod* Severe 25 5 <1 18 3 0 15 2 0 8 2 0 6 1 0 End of Treatment (Week 12) Mild Mod* Severe 15 2 0 8 1 0 6 <1 0 2 <1 0 1 <1 0 Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown. Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel based on mg/m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation. Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with ACANYA Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g ACANYA Gel, based on mg/m2) revealed no effects on fertility or mating. HOW SUPPLIED ACANYA Gel is supplied as a 50 g pump (NDC 13548-132-50). Dispensing instructions for the pharmacist Dispense ACANYA Gel with a 10 week expiration date. Specify “Store at room temperature up to 25°C (77°F). Do not freeze.” Storage and Handling PHARMACIST: Prior to dispensing, store in a refrigerator, 2°C to 8°C (36°F to 46°F). PATIENT: Store at room temperature at or below 25°C (77°F). Protect from freezing. Keep out of the reach of children. Keep container tightly closed. *Mod=Moderate RX Only DRUG INTERACTIONS Erythromycin ACANYA Gel should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known. Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107 Concomitant Topical Medications Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents. Manufactured by Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213 © 2010 CORIA Laboratories May 2012 | 19 DermatologyTimes.com quick takes news briefs Getty Images/David DearPhotographer’s Choice RF ◾ finasteride labels change Washington — The product labels for finasteride are being changed to warn patients about the potential for sexual side effects that may linger even after they stop taking the drug. Merck’s Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) had already been linked to sexual side effects. The Food and Drug Administration expanded the warnings after receiving reports of sexual disorders that lasted for several weeks to several months after discontinuation of the drug, Medscape reports. Propecia, used to treat male pattern baldness, will now include warnings about the potential for ejaculation, libido and orgasm disorders. Proscar, used to treat symptoms of enlarged prostate, will warn patients about the potential for decreased libido. Both of the medications will also include warnings about the risk for male infertility and poor semen quality, which normalized or improved after patients stopped taking the drug. patients. ICG was administered intravenously and diode laser pulses with different radiant exposures were applied as a single treatment immediately afterward. The patient and a blinded investigator evaluated safety and efficacy at one and three months after treatment. Reference therapy was treatment with pulsed dye laser and diode laser without ICG. HealthDay News reports that the safety of ICG application and diode laser treatment were rated excellent for all patients, with no persisting side effects. Researchers found clearance to be dose-dependent. offThe Beat Healing thyme: Herbal tincture effective for acne dublin — Herbal preparations containing thyme could be more effective for treating acne than prescription creams, according to research presented at the Society for General Microbiology’s recent Spring Conference. Investigators from Leeds Metropolitan University tested the effects of thyme, marigold and myrrh tinctures on Propionibacterium acnes and found that while all three killed the bacterium in vitro after five minutes’ exposure, ◾ fda to rule on lyme testing Washington — The Food and Drug Administration is expected to soon decide whether VGV-L, a drug candidate from Viral Genetics targeting chronic Lyme disease, can move to human trials. PRWeb reports that company researchers, working in conjunction with various institutions, submitted a pre-IND (Investigational New Drug) briefing to the FDA, an early step toward eventual clinical testing of the drug. The pre-IND submission comes after more than two years of testing. A protocol for a human clinical trial was submitted in April to the FDA along with test results. ◾ 70+ sPf sunscreens Protect los angeles — Water-resistant sunscreen with a sun protection factor of 70 or greater can help to adequately protect people against skin cancer and photodamage, even when applied sparingly, a new study suggests. The study, published in the April issue of the Journal of the American Academy of Dermatology, cites the use of sunscreen with a minimum sun protection factor (SPF) of 70. Researchers from Neutrogena and other consumer companies measured the effectiveness of six sunscreens when applied in amounts typically used by consumers. Volunteers applied the sunscreens, with protection labeled from 30 SPF to 100 SPF, in varying densities to determine how well the products shield skin against solar rays. According to HealthDay News, the study found the greatest benefits came from sunscreen labeled 70 SPF or greater, even at lower application densities. Data also showed a linear relationship between application density and actual SPF. ◾ icg, lasers treats leg veins regensburg, germany — German researchers report that diode laser therapy augmented with indocyanine green (ICG) results in good to excellent clearance of telangiectatic leg veins with no persisting side effects. Investigators from University Hospital Regensburg assessed the safety and efficacy of ICG-augmented diode laser therapy for the treatment of telangiectatic leg veins in 15 female ◾ stem cells sParK hair groWth tokyo — Transplanted hair follicles derived from adult stem cells have demonstrated normal hair cycles in bald mice, according to a recent study published in Nature Communications. Researchers at Tokyo University of Science bioengineered hair follicle germ cells from adult epithelial stem cells and dermal papilla cells. They then implanted the bioengineered cells into the skin of bald mice, resulting in thyme was the most effective, according to Medical News Today. The effects were measured against an alcohol control. Researchers also found that thyme had a greater antibacterial effect than standard concentrations of benzoyl peroxide, commonly used in anti-acne creams. The initial findings indicate the need for further tests to determine how such tinctures work, investigators say. DT normal hair cycles and other signs of normal function, including piloerection, or goosebumps, Medical News Today reports. Along with normal functioning, the implanted hair follicles also developed the correct structures and made the right connections with surrounding tissue, according to the report. Age, race, lesion location and area of country for patient treatment were significantly associated with MMS use, the authors write. The highest proportion of MMS among Medicare patients was in Georgia, at 45.1 percent, while the lowest rate was in Louisiana, at 11.0 percent. ◾ medicare surgeries double new york — The use of Mohs micrographic surgery to treat nonmelanoma skin cancer among Medicare beneficiaries doubled from 2001 through 2006, a study published in the April issue of Archives of Dermatology reports. Researchers reviewed a sample of Medicare beneficiaries who received surgical intervention to treat NMSC from 2001 through 2006. About 36 percent of the reported 26,931 operations were MMS. The rate of MMS doubled during this time, while the rate of surgical excision increased slightly. HealthDay News reports that MMS was used to treat about 15 percent of total body lesions, and nearly half of all facial lesions among Medicare recipients. ◾ mystery sKin disease Kills 19 Quang ngai, vietnam — Fourteen out of 26 blood samples from patients with a mysterious skin disease in the central province of Quang Ngai have tested positive for the rickettsia virus, which is transferred from animals to people by lice or fleas, Viet Nam News reports. The disease has affected 172 people and killed 19 in the province’s rural communes. The provincial health department has asked the province to provide financial assistance to equip medical facilities with blood filters and medications to treat affected patients. The World Health Organization has also said that it is ready to support the Vietnamese government in containing the disease, which was first reported last year. DT 20 DT news Dermatology Times | May 2012 ... From page 1 DistAnt DiAGnosinG Reimbursement still a hurdle Dr. Armstrong Currently, there are 37 active teledermatology programs in the United States, according to April W. Armstrong, M.D., M.P.H., assistant professor of dermatology and director of teledermatology at University of California Davis Health System, Sacramento. That’s down from 60 such programs identified in a 2003 survey by the American Telemedicine Association’s Dermatology Special Interest Group. However, the volume of dermatology consults per site actually doubled over that period, says Dr. Armstrong, a member of the American Academy of Dermatology’s Telemedicine Task Force and an author of a 2011 survey of telederm programs. “Even t houg h we have fewer programs, the programs that we do have seem to provide a lot of telemedicine services,” she says. The study, published in the January issue of Archives of Dermatology, gives high marks to teledermatology. Reviewing primary care records, Dr. Armstrong and colleagues found that 1,500 live interactive teledermatology consultations resulted in changes in diagnosis in 69.9 percent of patients and changes in disease management in 97.7 percent of patients. “It is one of the few outcome studies in the field,” Dr. Armstrong says. Who is using it? A broad spectrum of private practices, healthcare organizations and the government are already employing teledermatology, last year’s survey shows. Teledermatology sites offer a range of capabilities, including live interactive videoconferencing and the online store-and-forward approach, with which referring providers upload or send images of patients’ skin problems in encrypted medical records. Health maintenance organizations in particular are embracing the capability, according to Dr. Armstrong. “For example, Kaiser Permanente in southern California last year provided over 6,000 (teledermatology) consultations, and this year they’re story highlights ◾ Teledermatology offers options ◾ Derms can provide consults from workplace or from home ◾ Reimbursement remains limited; training, image quality are issues projected to provide about 10,000 consultations,” she says. Teledermatology can help guide primary care providers where local dermatologists aren’t readily available. The capability also can assist with triaging patients into conventional dermatology clinics and can provide remote support to clinics staffed by physician extenders with some dermatology training, according to Dennis H. Oh, M.D., Ph.D., associate professor of dermatology, University of California, San Francisco, and vice chairman of the American Telemedicine Association’s Teledermatology Special Interest Group. Teledermatolog y a lso br i ngs sophisticated dermatological expertise to rural areas — for example, the Alaska Native Medical Center in Anchorage, operates a well-established program — and provides extensive support to military personnel. “Telederm is one of the most successful telemedicine programs for the Army,” says Dr. Pak, who served 28 years in the Dr. Pak Army, where he designed, developed and implemented one of the largest telederm programs in the country. He later became president of the American Telemedicine Association. With more than 40,000 cases logged to date, the military uses teledermatology not only to support its U.S. clinics but also to get fast answers for providers caring for soldiers at war, Dr. Pak says. Teledermatology also benefits those who have limited access to specialists because of their occupations. One example: the cruise ship industry. University of Miami Miller School of Medicine has contracted with Royal Caribbean International to provide teledermatology consults 24/7 to the cruise line’s 20,000 crew members on 33 ships worldwide. Why all the interest? Dr. Armstrong says organizations and providers are realizing that today’s technology allows them to meet consumer demands for quicker diagnoses and easier access to healthcare. Dermatologists in private practice who want more flexibility and less overhead also see teledermatology as a way to supplement income and stay active in the specialty. For example, Marc E. Goldyne, M.D., Ph.D., clinical professor of dermatology, University of California, San Francisco, Dr. Goldyne has devoted his career to teledermatology. “I’ve seen more than 4,000 consu lts over the last 10 years, and they can be any thing from skin cancer, including melanoma, to psoriasis, to eczema to childhood moles,” he says. “Any of the visible skin conditions that you can find in a textbook will be inclusive of the things that we see in teledermatology.” Dr. Goldyne, who is also staff physician, San Francisco VA Medical Center, and chairman of the American Telemedicine Association’s Teledermatology Special Interest Group, says he has the freedom to work from home when consulting on cases that employ store-and-forward technology. And while he says he makes less in reimbursements for teledermatology than for seeing patients face-to-face, he notes that he doesn’t have the overhead of having to pay staff or office rent. Barriers to growth Still, reimbursement remains the biggest barrier preventing teledermaDistant see page 23 Getty Images/Nicholas Eveleigh/Digital Vision Telederm landscape NOW APPROVED! For more information, visit www.Erivedge.com Indication Erivedge™ (vismodegib) capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS Erivedge (vismodegib) capsule can result in embryo-fetal death or severe birth defects. Erivedge is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of Erivedge exposure through semen. Boxed Warning and Additional Important Safety Information Embryo-Fetal Death and Severe Birth Defects • Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action • Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen • Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant • Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555 Blood Donation • Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge Nursing Mothers • Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother Adverse Reactions • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia • In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge • Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%) Please see Brief Summary of Prescribing Information on the following page. © 2012 Genentech USA, Inc. All rights reserved. HED0000822700 Printed in USA. Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients (cont) MedDRA Preferred Term 2 Metabolism and nutrition disorders Decreased appetite Musculoskeletal and connective tissue disorders Muscle spasms Arthralgias Nervous system disorders Dysgeusia Ageusia Skin and subcutaneous tissue disorders Alopecia ERIVEDGE (vismodegib) capsule Initial U.S. Approval: 2012 This is a brief summary of information about ERIVEDGE. Before prescribing, please see full prescribing information. WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS ERIVEDGE (vismodegib) capsule can result in embryo-fetal death or severe birth defects. ERIVEDGE is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of ERIVEDGE exposure through semen [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)]. All aBCC1 Patients (N = 138) All Grades 3 Grade 3 Grade 4 (%) (%) (%) 35 (25.4%) 3 (2.2%) - 99 (71.7%) 22 (15.9%) 5 (3.6%) 1 (0.7%) - 76 (55.1%) 15 (10.9%) - - 88 (63.8%) - - 1 1 INDICATIONS AND USAGE ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. 2 DOSAGE AND ADMINISTRATION The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies (14)]. ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules. If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Embryo-Fetal Death and Severe Birth Defects ERIVEDGE capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Vismodegib is teratogenic, embryotoxic, and fetotoxic in rats at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day. In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning. If ERIVEDGE is used during pregnancy or if a patient becomes pregnant while taking (or for a male patient, if his female partner is exposed to) ERIVEDGE, the patient should be apprised of the potential hazard to the fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Use in Specific Populations (8.1, 8.6)]. 5.2 Blood Donation Advise patients not to donate blood or blood products while receiving ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer. The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1). Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients All aBCC1 Patients (N = 138) MedDRA Preferred Term2 Gastrointestinal disorders Nausea Diarrhea Constipation Vomiting General disorders and administration site conditions Fatigue Investigations Weight loss All Grades 3 (%) Grade 3 (%) Grade 4 (%) 42 (30.4%) 40 (29.0%) 29 (21.0%) 19 (13.8%) 1 (0.7%) 1 (0.7%) - - 55 (39.9%) 7 (5.1%) 1 (0.7%) 62 (44.9%) 10 (7.2%) - aBCC = Advanced Basal Cell Carcinoma. MedDRA = Medical Dictionary for Regulatory Activities. 3 Grading according to NCI-CTCAE v3.0. Amenorrhea: In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology (13.1)]. Laboratory Abnormalities: Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%). 2 7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on Vismodegib Drugs that Inhibit or Induce Drug Metabolizing Enzymes Vismodegib elimination involves multiple pathways. Vismodegib is predominantly excreted as an unchanged drug. Several minor metabolites are produced by multiple CYP enzymes. Although vismodegib is a substrate of CYP2C9 and CYP3A4 in vitro, CYP inhibition is not predicted to alter vismodegib systemic exposure since similar steady-state plasma vismodegib concentrations were observed in patients in clinical trials concomitantly treated with CYP3A4 inducers (i.e., carbamazepine, modafinil, phenobarbital) and those concomitantly treated with CYP3A4 inhibitors (i.e., erythromycin, fluconazole). Drugs that Inhibit Drug Transport Systems In vitro studies indicate that vismodegib is a substrate of the efflux transporter P-glycoprotein (P-gp). When ERIVEDGE is coadministered with drugs that inhibit P-gp (e.g. clarithromycin, erythromycin, azithromycin), systemic exposure of vismodegib and incidence of adverse events of ERIVEDGE may be increased. Drugs that Affect Gastric pH Drugs that alter the pH of the upper GI tract (e.g. proton pump inhibitors, H2-receptor antagonists, and antacids) may alter the solubility of vismodegib and reduce its bioavailability. However, no formal clinical study has been conducted to evaluate the effect of gastric pH altering agents on the systemic exposure of vismodegib. Increasing the dose of ERIVEDGE when coadministered with such agents is not likely to compensate for the loss of exposure. When ERIVEDGE is coadministered with a proton pump inhibitor, H2-receptor antagonist or antacid, systemic exposure of vismodegib may be decreased and the effect on efficacy of ERIVEDGE is unknown. 7.2 Effects of Vismodegib on Other Drugs Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) or oral contraceptives (ethinyl estradiol and norethindrone) is not altered when either drug is co-administered with vismodegib. In vitro studies indicate that vismodegib is an inhibitor of CYP2C8, CYP2C9, CYP2C19 and the transporter BCRP. Vismodegib does not induce CYP1A2, CYP2B6, or CYP3A4/5 in human hepatocytes. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D ERIVEDGE capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Vismodegib is teratogenic in rats at doses corresponding to an exposure of 20% of the exposure at the recommended human dose (estimated AUC 0-24hr steady-state exposure). In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Vismodegib is embryolethal in rats at exposures within the range achieved at the recommended human dose. If ERIVEDGE is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the embryo or fetus. Report immediately exposure to ERIVEDGE during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to ERIVEDGE during pregnancy, either directly or through seminal fluid, to participate in the ERIVEDGE pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Warnings and Precautions (5.1)]. In an embryo-fetal developmental toxicity study, pregnant rats were administered oral vismodegib at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times the systemic exposure (AUC) in patients at the recommended human dose), which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the recommended dose) resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws). 8.3 Nursing Mothers It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ERIVEDGE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and effectiveness of ERIVEDGE capsule have not been established in pediatric patients. In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the systemic exposure (AUC) in patients at the recommended human dose). Abnormalities in growing incisor teeth (including degeneration/ necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in patients at the recommended human dose). 8.5 Geriatric Use Clinical studies of ERIVEDGE capsule did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 8.6 Females of Reproductive Potential and Males ERIVEDGE capsule can cause harm to the embryo or fetus when administered during pregnancy. Counsel female and male patients regarding pregnancy prevention and planning. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant [see Boxed Warning, Warnings and Precautions (5.1), Use in Specific Populations (8.1)] Female patients Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of ERIVEDGE. If a patient becomes pregnant while taking ERIVEDGE, or during the 7 months after the last dose of treatment, report the pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage pregnant females to participate in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. Counsel pregnant females about the teratogenic risk to the fetus. Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of amenorrhea is unknown [see Adverse Reactions (6), Nonclinical Toxicology (13.1)]. Male patients Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with ERIVEDGE capsule and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib. 8.7 Hepatic Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with hepatic impairment [see Clinical Pharmacology (12.3)]. 8.8 Renal Impairment The safety and effectiveness of ERIVEDGE capsule have not been established in patients with renal impairment [see Clinical Pharmacology (12.3)]. 10 OVERDOSAGE There is no information on overdosage in humans. In clinical trials, ERIVEDGE capsule was administered at 540 mg orally once daily; exposure did not increase between 150 mg and 540 mg daily. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). • Advise patients that ERIVEDGE exposure during pregnancy can cause embryo-fetal death or severe birth defects. • Instruct female patients of reproductive potential to use a highly effective form of contraception (failure rate of less than 1%) while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. • Instruct all male patients, even those with prior vasectomy, to use condoms with spermicide, during sexual intercourse with female partners while taking ERIVEDGE and for at least 2 months after the last dose of ERIVEDGE. • Instruct patients to immediately contact their healthcare provider if they (or, for males, their female partner) become pregnant or if pregnancy is suspected following exposure to ERIVEDGE. • Instruct patients to immediately report any pregnancy exposure to ERIVEDGE and encourage participation in the ERIVEDGE pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. • Inform female patients of the potential for serious adverse reactions in nursing infants from ERIVEDGE, taking into account the importance of the drug to the mother. • Advise patients not to donate blood or blood products while taking ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE. • Advise patients to swallow ERIVEDGE capsules whole and not to crush or open the capsules. ERIVEDGE™ [vismodegib] capsule Manufactured by: Patheon, Inc. Mississauga, Canada Distributed by: Genentech USA, Inc. ERIVEDGE is a registered trademark A Member of the Roche Group of Genentech, Inc. © 2012 Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 1013 5 4 9 3 HED0000832300 May 2012 | DT news DermatologyTimes.com Distant from page 20 tology from reaching its full potential, according to Anne E. Burdick, M.D., M.P.H., associate dean for telehealth and clinical outreach and professor of dermatology, University of Miami Miller School of Medicine, Miami. “There is limited reimbursement by CMS (Centers for Medicare and Medicaid Services) and private payers. In some states, there are mandates for all payers — private and government — to pay for teleconsultations. But in most of the states, including Florida, state mandates do not exist,” she says. Still, doctors or institutions have found ways around the reimbursement issue, such as contracting with groups, organizations or businesses to provide services. Training is another barrier. Most residency programs do not offer practical experience or instruction in teledermatology, according to Dr. Armstrong. “As a result, when dermatologists go out into the workforce, they are less likely to practice telemedicine,” she says. University of Missouri is among the few medical schools and residency programs to include telehealth, according to Karen E. Edison, M.D., Philip C. Anderson professor and chairwoman, department of dermatology, and medical director, Missouri Telehealth Network, University of Missouri Health System, Columbia, Mo. In dermatology, especially, the program thrives, she says. “We conduct two half-day teledermatology clinics weekly — one (in) general dermatology, and one (in) pediatric dermatology,” she says. The program operates telehealth sites in most rural counties throughout the state of Missouri. “In a single dermatology clinic, we may care for patients in 20 or 30 locations,” Dr. Edison says. “Many specialties use telehealth in our institution, but dermatology is one of the top three users.” Yet another issue holding telemedicine back is the quality of transmitted images, even though it is improving, according to Dr. Armstrong. “I think there needs to be a greater effort in terms of educating people who do teledermatology,” she says. “For example, the coordinator at the referral site needs to know how to take the photographs, so it gives us the best chance to an accurate diagnosis.” The upside Doctors who use teledermatology stand by its value. Not only does the virtual consultation method improve access, especially for patients in rural areas and areas underserved by dermatologists, but also it is convenient for providers and patients. “Because we do teleconsultations … I’m not traveling to different counties to provide care,” Dr. Burdick says. As for the research, most studies on teledermatology have been encouraging regarding efficacy, according to Dr. Oh. A 2010 review of literature did report that “Accuracy of teledermatology is inferior to in-person dermatology care, especially for skin malignancies,” but acknowledged that “Little information exists on the impact of teledermatology on clinical outcomes” (Warshaw E, et al., published January 2010 by the Department of Veterans Affairs). That review also found patient and provider satisfaction with teledermatology to be “relatively high, though there were individuals who have strong beliefs for a particular approach.” Another potential benefit: Teledermatology also may help improve primary care providers’ dermatology knowledge because of the collaboration between dermatologists and referring providers, according to Dr. Burdick. “I have seen (that) primary care providers … have gotten an enhanced knowledge base of skin disease and treatment options,” she says. Dr. Goldyne says, as far as he is concerned, the quality of care possible with teledermatology rivals that of an in-person consultation. “Having done store-and-forward telemedicine now for about 10 years, I feel as confident in making the diagnosis as I do if the patient is in my office,” he says. In the rare cases where he isn’t sure, he recommends that the patient visit a dermatologist in person. “I would say that might be three out of 100 patients,” he says. “In a single dermatology clinic, we may care for patients in 20 or 30 locations.” Karen E. Edison, M.D. Medical director, Missouri Telehealth Network What about costs? While dermatologists who practice teledermatology say it is cost-effective, studies have yet to prove this. Even a literature review published in the January 2012 issue of the Journal of Telemedicine and Telecare found no conclusive evidence that telemedicine interventions are cost-effective compared to conventional healthcare. But Dr. Goldyne is convinced that patients save money. For instance, those who must travel hundreds of miles to visit the nearest dermatologist can save expenses such as gas, food and sometimes even lodging, he says. Dr. Armstrong says more studies are needed to determine the costeffectiveness of teledermatology and various telehealth interventions. Tele take-home Experts say access to quality care will push teledermatology into the mainstream. “While in-person dermatology may prov ide bet ter d ia g nost ic and-or management accuracy when compared with teledermatology, teledermatology is always better than no dermatology,” Dr. Burdick says. Dr. Pak says he sees widespread adoption of teledermatology in the next five to 10 years. Medicare and Medicaid will get on board with telemedicine, he predicts, because of pressure from current healthcare reform to increase access, provide evidencebased medicine and cut costs. “This is all about reimbursement,” Dr. Pak says. “Technology has been proven. Outcomes studies have been done. Standards have been developed. Everything (is in place) but the reimbursement policy.” DT 23 24 DT news Dermatology Times | May 2012 ... From page 1 Fine tuning: IL-17 blockade yields ‘high control’ studies published March 29 in the New England Journal of Medicine (2012;366(13):1181-1189 and 11901199, respectively). Both studies were double-blinded and placebocontrolled. “Both trials showed that patients receiving the antibody had marked improvements in the (Psoriasis Area and Severity Index) PASI score,” wrote Ari Waisman, Ph.D., in a commentary editorial (1251-1252). Dr. Waisman is professor of medicine, Institute for Molecular Medicine, University Medical Center at the Johannes-Gutenberg University of Mainz, Germany. He added that the IL-17 approach may address some of the concerns seen with other biologic therapies such as tumor necrosis factor (TNF) inhibitors. While anti-TNF drugs have improved treatment choices for patients with autoimmune diseases, the need for biologic agents that demonstrate “fewer side effects and a milder effect on the immune system” is clear, he wrote. Brodalumab The study on brodalumab involved 198 patients with baseline PASI scores of at least 12 who were randomly assigned to active therapy or placebo. Patients on treatment were further randomized to receive doses of 70 mg, 140 mg or 210 mg on the first day of treatment and at weeks one, two, four, six, eight and 10, or to receive 280 mg monthly through the study’s duration. By week 12, the average improvement was 45.9 percent for those on 70 mg, 85.9 percent for those on 140 mg, 86.3 percent for those on 210 mg, and 76.0 percent for those on 280 mg. The average improvement for those on placebo was 16.0 percent (p<0.001 for all treatment groups compared to placebo). Investigators story highlights ◾ IL-17 inhibitors show promise for treatment of psoriasis ◾ Studies indicate targeting receptor leads to “profound response” ◾ No serious side effects reported saw a PASI improvement of 75 percent in 77 percent of those on 140 mg and 82 percent of those on 210 mg, compared to none on placebo. The second study involved 142 patients on ixekizumab or placebo, with patients on active treatment randomized to 10 mg, 25 mg, 75 mg or 150 mg of ixekizumab at the study’s onset and at weeks two, four, eight and 12. In that study, investigators saw a PASI improvement of 75 percent in 76.7 percent of those on 25 mg, 82.8 percent of those on 75 mg, and 82.1 percent of those on 150 mg, compared to 7.7 percent of patients on placebo (p<0.001 compared to all treatment groups). These improvements persisted through a 20-week follow-up period after treatment was concluded. In separate phone interviews with Dermatology Times, the principal investigators for Dr. Papp t he respec t ive studies discussed the results’ implications. Kim A. Papp, M.D., Ph.D., led t he brodal u m a b s t u d y. He is director of research, Probity Medical Research, a consortium of clinical investigators in Waterloo, Ontario, Canada. Craig Leonardi, M.D., who led the ixekizumab study, is clinical professor of dermatology at Saint Louis University School of Medicine in St. Louis. Breadth of response A new look in the works… You may have noticed some changes to the look of this month’s Dermatology Times. We’re in the process of freshening our layouts in an effort to make the magazine easier and more enjoyable to read! Of course, we’ll continue to bring you the timely, compelling editorial content you need to keep your practices thriving. Stayed tuned for further updates in the coming months… and feel free to contact me with any suggestions at [email protected]. Amy Stankiewicz, Editor-in-Chief “Our study shows that blockade of IL-17 provides a high degree of control of psoriasis,” Dr. Papp says. “That IL-17 is instrumental in the pathogenesis of psoriasis is proven. The breadth of the response is a demonstration of future hope of a very effective treatment for psoriasis and that IL-17 plays a pivotal role.” Targeting the IL-17RA receptor, he says, leads to a “profound response.” While TNF antagonists have been effective, the progress in targeting IL-RA represents “a quantum leap.” Developing new treatments such as brodalumab is particularly important in the treatment of psoriasis, Dr. Papp says. “Psoriasis patients need new therapies,” he says. “We have really not been able to fully address treatment of patients with psoriasis and psoriatic arthritis. We need new therapies and refinements of those already in the clinic.” Novel therapies can address problems commonly seen in the management of psoriasis, such as loss of response and breakthrough symptoms. The ixekizumab trial “showed that the three largest doses (yielded) a high performance with regards to clearing psoriasis,” says Dr. Leonardi D r. L e on a rd i , who was also a co-investigator in the brodalumab trial. “The two studies together validate the i mpor ta nce of blocking IL-17. Both studies had very impressive efficacy and (both drugs) were welltolerated. Improvement is considered significant at the benchmark of PASI improvement of at least 75 (PASI 75). “For the three highest doses of ixekizumab, roughly 80 percent achieved PASI 75,” Dr. Leonardi says. “In addition, 40 percent of patients treated with the two highest doses achieved PASI 100,” or complete clearing. No adverse events Tolerability results caused the investigators to characterize the trial as an “absolutely quiet trial,” Dr. Leonardi says. “There were no serious adverse events of any type, not even accidental injury,” he says. Instead, investigators saw more common adverse events, such as headache and pharyngitis, but “none seemed dose-related.” Two cases of neutropenia were seen. In t he ongoing phase 3 tria l, researchers will seek to determine whether ixekizumab is associated with any safety concerns in a larger database of participants. A phase 3 trial of brodalumab is expected to launch later in 2012. DT Disclosures: Drs. Leonardi and Papp have received consulting fees from both companies as well as others. Neither owns stock in either company. 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AVAILABLE AT SELECT CVS/PHARMACY, ULTA, WALGREENS, DUANE READE AND PHYSICIAN OFFICE LOCATIONS AS WELL AS ONLINE AT WWW.LAROCHE-POSAY.US 26 Dermatology Times clinical dermatology Veinadvice 30 32 34 | May 2012 New drug delivery Laser device advancements may target more than fat removal Beyond aesthetics Botulinum toxin plays role for dermatologic conditions Combination care Pairing topical therapies advantageous for psoriasis Careful laser selection, combination therapies set standard for vascular treatment By John Jesitus Senior Staff Correspondent Vascular treatments are undergoing a renaissance that includes combinations of lasers and sclerosing technologies. New York — The revolution in treatments for venous incompetence includes combinations of lasers and sclerosing technologies for leg veins, along with the gold standard of pulsed dye lasers for facial telangiectasias, hemangiomas and port wine stains, according to Neil Sadick, M.D. Successful treatment requires choosing the right wavelength to target blood vessels lying at different levels within the dermis, or those with thicker or thinner endothelial linings, says Dr. Sadick, clinical professor of dermatology at Weill Dr. Sadick Cornell Medical College, New York. “For facial telangiectasias, several wavelengths can be utilized. For very discrete blood vessels, one can use a very short wavelength 532 nm KTP laser. The gold standard for smaller vessels is the pulsed dye laser, at 585 to 600 nm,” along with intense pulsed light (IPL) with cutoff filters at 500 nm to 1,000 nm, he says. For larger blue vessels, particularly around the eyes or in the temporal area, “We sometimes use intermediate- or long-pulsed 1,064 nm Nd:YAG lasers,” Dr. Sadick says. In treating rosacea, vascular-targeting lasers can reduce not only hemoglobin and flushing, but also inflammation, sebaceous gland activity and the presence of pathogens such as Demodex organisms around the pilosebaceous units, Dr. Sadick explains, adding that IPL devices are especially good for diffuse flushing syndromes. “For deeper f lushing syndromes, we like using the intermediate-pulsed 1,064 nm Nd:YAG laser, particularly for diffuse flushing syndromes, for deeper and larger blood vessels and for darker skin phenotypes and periorbital veins,” he says. In treating hemangiomas, Dr. Sadick says, “The pulsed dye laser is the gold standard for superficial lesions. But for deeper lesions, we sometimes use other wavelengths.” For example, he says that for thicker, deeper lesions, “We might use a 1,064 nm Nd:YAG laser, or a 755 nm alexandrite laser. For more superficial vessels, we may also occasionally use a very shortwavelength 532 nm KTP laser.” For port wine stains, “We sometimes use combination approaches as well,” he says. “We usually treat the superficial vessels first, then the deeper, more recalcitrant vessels. Multiple treatments may be necessary. But again, the pulsed dye laser is the gold standard. And we now treat these lesions earlier in life because this approach is associated with fewer treatments and better outcomes.” Vascular advances see page 29 DT Extra Few genes altered in XLRI patients “Topical therapies are important for virtually everyone who has psoriasis.” David M. Pariser, M.D. Norfolk, Va. t a On combination treatments for psoriasis See story, page 34 e g e t A small number of genes have altered expression in patients with X-linked recessive ichthyosis (XLRI), according to a study published online April 5 in the British Journal of Dermatology. Researchers with Uppsala University, Sweden, examined biophysical and molecular changes in the skin of 14 patients with XLRI and 14 controls. Patients with XLRI had increased dryness and a transepidermal water loss but equal skin pH. Patients treated tr e with moisturizers demonstrated improved skin dryness, but bu no n effect on pH, transepidermal water loss or expression of genes n was found. Source: HealthDay News Getty Images/Collection/Credit Quotable May 2012 | clinical dermatology DermatologyTimes.com VascuLar adVancEs: Treatments for venous incompetence grow from page 26 For leg veins, Dr. Sadick says he typically uses external lasers including the gold standard long-pulsed 1,064 nm Nd:YAG to target spider veins. A 52-year-old female patient with volume loss and visible veins on the hands before (left) and eight weeks after one endovenous laser treatment for the hands. Laser advances In recent years, laser technologies have improved through the inclusion of advanced cooling technologies and the ability to match the fluence, spot size and pulse duration with vessel size and color, Dr. Sadick says. “Leg veins differ from facial telangiectasias because leg veins have increased hydrostatic pressure. Also, lower extremity vessels are larger and have an increased thickness of the basal lamina compared to facial telangiectasias,” he says. Dr. Sadick also says it’s more difficult for light sources to access the deeper location of lower-extremity veins. Compared to facial telangiectasias, he adds, leg veins also exhibit altered cytokine patterns upon injury with light sources. Therefore, “Different treatment wavelengths and protocols are used in treating leg veins versus facial veins.” For example, he says that for superficial telangiectasias on the leg, which have a reddish hue because they contain increased amounts of oxygenated hemoglobin, “We would use a 1,064 nm Nd:YAG laser, but with a high fluence, a short pulse duration and a small spot size.” Vessels that look more bluish usually lie deeper, Dr. Sadick says. In such cases, “We’d use the 1,064 nm Nd:YAG laser with a slightly larger spot size and a slightly more extended pulse duration.” A larger spot size and longer pulse allow the energy to be delivered to deeper, slightly larger vessels, he explains. Moreover, he says that after leg vein treatment with light sources, patients do not need compression therapy. In a study that Dr. Sadick co-authored, investigators used a tunable pulsed dye laser (VBeam, Candela) to treat both legs of 13 patients with leg veins measuring 0.5 nm to 1.0 mm in diameter. They then had patients wear Class II compression stockings on the left leg during waking hours for one week. At this point, investigators found no significant differences between patients’ right and left legs in terms of results or (Photos: Neil Sadick, M.D.) side effects (Sadick NS, Sorhaindo L. Phlebology. 2006. 21(4):191-194). Indications for cosmetic laser treatment of leg veins (versus sclerotherapy) include the presence of non-cannulizable vessels, needle phobia, sclerosant resistance and multiple sclerosant allergies, Dr. Sadick says. In recent years, dermatologists also have revolutionized the treatment of incompetence in axial veins including the short and long saphenous vein by using endovenous laser fibers operating at various wavelengths to target either hemoglobin, or water and collagen, Dr. Sadick says. Presently, dermatologists commonly use diode lasers operating at 810 nm, 940 nm and 980 nm for this purpose, he explains. “However, these lasers are being replaced by longer-wavelength water- and collagen-absorbing lasers operating at 1,319, 1,320 and 1,470 nm. Lasers that target water and collagen rather than hemoglobin seem to be associated with less patient discomfort and post-treatment bruising.” EVLT Endovenous laser therapy (EVLT) of the saphenous vein causes ablation of reflux via vein occlusion, says Dr. Sadick. “It also shrinks the vein by causing damage to endothelial cells and the inner vein wall, and secondary occlusion of the lumen through the formation of a blood clot.” Additional advantages of EVLT include the fact that it’s done as an outpatient procedure under tumescent anesthesia, the latter of which makes the procedure virtually painless and bloodless, Dr. Sadick says. After treatment, “Patients are wrapped in an elastic bandage, then undergo compression therapy for 10 to 14 days. But usually, they can go back to work the next day,” he says, adding that postoperatively, EVLT results in very little discomfort, no scarring and minimal downtime. In practice, “We commonly use a combination of EVLT with either foam sclerotherapy of associated tributaries, or ambulatory phlebectomy,” Dr. Sadick says. With either approach, “It’s been shown in long-term studies that the outcomes in terms of recurrence are at least as good as or better than those of the older, more invasive surgical ligation and stripping techniques.” In one such study, Dr. Sadick and his co-authors analyzed four-year followup data from a series of 90 patients treated for greater saphenofemoral junction incompetence using 810 nm diode EVLT plus ambulatory phlebectomy of remaining truncal varicosities. To ensure closure, investigators performed duplex ultrasound examinations at one week, then at one, three, six, 12, 24, 36 and 48 months post-treatment. Among a total of 94 limbs treated, researchers observed a recurrence rate of only 4.3 percent (Sadick NS, Wasser S. J Cosmet Laser Ther. 2007;9(1):9-13). DT Disclosures: Dr. Sadick has received research grants from Cutera, Cynosure, Palomar, Solta and Syneron. He is also a consultant for Solta and Cynosure. 29 30 Dermatology Times clinical dermatology | May 2012 Noninvasive news Future laser and other technologies will target more than fat, physicians say By John Jesitus Senior Staff Correspondent Wailea, Hawaii — In coming years, the trend toward less invasive technologies will continue not only in fat removal and body sculpting treatments, but also in new modalities for delivering a variety of drugs, according to physicians who spoke at MauiDerm 2012: Advances in Cosmetic and Medical Dermatology in February. “Some of the most exciting future technologies include using fractional laser technology to deliver drugs across the skin,” says Omar Ibrahimi, M.D., assistant professor of dermatology, dermatologic and Mohs surgery and director of cutaneous laser and cosmetic surgery at the University of Connecticut Health Center, Farmington. Recent research from the Wellman Center has shown that “a single hole made by ablative fractional resurfacing (AFR) increases the delivery of a drug logarithmically — it’s not just a two- or fourfold increase. It’s manyfold,” he says. “Some of the most exciting future technologies include using fractional laser technology to deliver drugs across the skin.” Omar Ibrahimi, M.D. University of Connecticut Health Center In a porcine model, investigators found that CO2 laser-ablated channels cut 1,850 µm deep, facilitating significantly increased topical methyl aminolevulinate (MAL)-induced porphyrin fluorescence and photodynamic therapy (PDT) response, both superficially and deep, versus topical MAL alone (Haedersdal M, Katsnelson J, Sakamoto FH, et al. Lasers Surg Med. 2011;43(8):804-813). In an earlier porcine study, the same Dermatologists increasingly will use noninvasive devices for much more than fat treatments. team of investigators found that treatment with an ablative fractional CO2 laser followed by topical MAL enhanced drug delivery, providing significantly higher porphyrin f luorescence of hair follicles (P<0.0011) and dermis (P<0.0433) versus MAL alone at skin depths ranging from 120 µm to 1,800 µm (Haedersdal M, Sakamoto FH, Farinelli WA, et al. Lasers Surg Med. 2010;42(2):113-122). Other medical advances “People are using fractional CO2 lasers followed by PDT to enhance therapies for skin cancers and actinic keratosis,” says Michael H. Gold, M.D., medical director, Gold Skin Care Center and Tennessee Clinical Research Center, and clinical assistant professor, Division of Dermatology, Vanderbilt University School of Medicine and Vanderbilt University School of Nursing, Nashville. “Those technologies are starting to play a big role now.” In a small case series, investigators have shown how AFR with a fractional CO2 laser improves MAL uptake and may intensify results of treatments for basal cell carcinoma (Haedersdal M, Togsverd-Bo K, Paasch U. Lasers Med Sci. 2012 Jan 6. [Epub ahead of print]). Likewise, Dr. Gold says that with the Legato iPixel plus ultrasound device (Alma), commercially available in Europe and Asia, “You can create holes in the skin. Then you apply an active onto the skin and ‘hammer’ it with ultrasound into the skin. The plan is to conduct U.S. trials on this device, which are expected to start within the next six to 12 months,” he says. “The machine is doing very well outside the United States, and its results are pretty impressive.” Dr. Gold says he has submitted an article on the device for publication. One very recent study shows that investigators were able to vaccinate mice using AFR (Chen X, Shah D, Kositratna G, et al. J Control Release. 2012 Jan 9. [Epub ahead of print]). Dr. Ibrahimi says this study showed that it’s possible to deliver large molecules through the skin, “whereas traditionally you couldn’t do that by topically applying large protein or peptide molecules.” Also in a mouse model, researchers used a blue methylene dye and red light to cure cutaneous Candida albicans infections (Dai T, Bil de Arce VJ, Tegos GP, Hamblin MR. Antimicrob Agents Chemother. 2011;55(12):5710-5717. Epub 2011 Sep 19). “AFR might ultimately be an ideal way to deliver insulin to diabetics so they won’t have to undergo needle sticks. This technology has many promising applications,” Dr. Ibrahimi says. regarding lipids With energy-based treatments such as lasers, Dr. Ibrahimi says, “Traditionally, we’ve been targeting pigment, blood or water in the skin. Now the next generation of applications might focus on other targets in the skin, such as lipids, which are present in sebaceous glands.” In this regard, he says, research might one day produce a laser that’s more selective in treating acne than current products are. Unlike PDT, which requires a photosensitizing agent, “This would be using a wavelength that’s absorbed more selectively by sebaceous glands,” Dr. Ibrahimi says. “There’s no photosensitizer needed.” Examples of such technology include the 1,720 nm laser under development at Harvard’s Wellman Center for Photomedicine, where Dr. Ibrahimi is a visiting assistant professor of dermatology. May 2012 | DermatologyTimes.com Presently, lipid- and acne-targeting devices are in very early developmental stages, Dr. Ibrahimi says, adding that such products likely will reach the market within the next five years, Dr. Gold dramatically changing the way acne is treated. aesthetic factors “Around the world,” says Dr. Gold, “researchers are looking at delivering skin lightening agents, minoxidil and botulinum toxins” using AFR. However, he says that because it’s difficult to get a prescription drug/device combination approved in the States, “We’ll be looking at over-the-counter active agents.” Examples could include hyaluronic acid for skin rejuvenation, and skin-lightening ingredients such as vitamin C and other skin-lightening actives, he says. Fractional technology also might allow delivery of growth factors or other wound-healing agents with greater efficiency than is currently possible topically, Dr. Ibrahimi says. He says that he and Suzanne Kilmer, M.D., have used AFR to treat a handful of patients with birthmarks, large congenital nevi or moles. “We’ve found that it’s an effective way to lighten these things and soften their appearance,” Dr. Ibrahimi says. “I can envision these applications becoming more popular in the future as well. We’re getting to applications beyond rejuvenation” with fractional lasers. Focusing on fat Dr. Gold says that presently, manufacturers and researchers are focusing primarily on improving existing devices that use cold or other targeted energy sources to reduce fat or cellulite, possibly by adding ultrasound or combining ultrasound and radiofrequency energy. “The fat devices we have on the market now are the CoolSculpting procedure (Zeltiq), Liposonix (Medicis), and perhaps someday the Contour 1 (UltraShape),” he says. “We’re taking these devices and seeing what kinds of improvements can be made as we move into their next generations.” He says that with ultrasound devices particularly, “We’re looking for ways to decrease pain, which will be very important.” Dr. Ibrahimi says that future lipid-targeting wavelengths might facilitate noninvasive fat treatments that appeal to patients hesitant to undergo more invasive procedures. Fat-fighting lasers also might provide a complement to the CoolSculpting procedure, which essentially freezes off fat, but only in areas of skin that can be drawn into its handpiece, he says. DT Disclosures: Dr. Ibrahimi has received an honorarium from Lumenis for a hair-removal study and owns stock in Zeltiq and Procter & Gamble. Dr. Gold has received grant/ research support from Ulthera. He is also a consultant for Syneron, Lumenis, Alma Lasers, Sciton, Ulthera and Venus Concept, and a speaker for Alma Lasers, Lumenis (in which he also owns stock), Syneron, Sciton, Ulthera, Venus Concept and Jeisys. Dermatology Times clinical dermatology | May 2012 Expanding role Clinical uses for botulinum toxin shine where standard therapies fail By Ilya Petrou, M.D. Senior Staff Correspondent Lisbon, Portugal — Above and beyond its therapeutic value in cosmetic medicine, botulinum toxin can be useful in a number of medical indications and can represent an adjunct treatment option, said Philippe Humbert, M.D., Ph.D., at the 20th annual European Academy of Dermatology and Venereology Congress last October. Both physicians and the public are well aware of the cosmetic benefits that botulinum toxin can have in skin rejuvenation treatments. The toxin can also prove useful in the treatment and/ or relief of numerous medical conditions, including hyperhidrosis, inverse psoriasis, hidradenitis suppurativa, eccrine tumors and vestibulodynia, says Dr. Humbert, professor and head of the department of dermatology, University Hospital, Besançon, France. “The common denominator of many dermatologic conditions and diseases is increased sweating, which in many cases can significantly aggravate the affected skin region, particularly in the folds of the skin. Treatments with botulinum toxin can at least temporarily minimize the sweating, subsequently resulting in an improvement of the local symptoms, which often can offer a great relief in affected patients,” Dr. Humbert says. sweating success According to Dr. Humbert, botulinum toxin treatments are very useful in treating dermatologic conditions associated with profuse sweating in the skin folds (axillary, inguinal and palmar and plantar hyperhidrosis). Other conditions associated with increased sweating in the folds with subsequent Botulinum toxin can improve numerous dermatologic conditions, and physicians should consider its use when more conventional therapies fall short. skin maceration and localized pain include inverse psoriasis, Hailey-Hailey disease (benign familial pemphigus) and Darier’s disease. Many of these conditions are challenging to treat, manage and control, Dr. Humbert says, and disease flare is sometimes aggravated by increased localized sweating (particularly in the fold areas). “I believe that for these dermatoses, botulinum toxin treatments should not be used as a monotherapy but instead used in combination with more conventional therapeutic approaches. Alleviating and/or stopping the localized increased sweating can offer a better milieu for the affected skin regions to heal,” Dr. Humbert says. Botulinum toxin treatments could be performed approximately every six months, which is very similar to the treatment protocols seen in cosmetic medicine. The doses of botulinum toxin used vary, Dr. Humbert says, depending on the type of toxin used and the severity of disease. “It must be said that these indications are off-label and do not offer a cure for the patient,” he says. “As such, the physician has the difficult task to establish that improvements achieved are due to the botulinum toxin treatment. There- fore, as these are symmetrical diseases, I would suggest to treat one side of the patient first and observe the therapeutic benefit, and if there is a good response, one can proceed to treat the other side. This approach helps to establish the treatment efficacy of the toxin in that particular disease and patient.” neurologic know-how Botulinum toxin treatment can also find utility in conditions and diseases that have a neurologic component, such as anal fissures, vestibulodynia, lichen simplex and notalgia paresthetica, Dr. Humbert says. Traditionally, anal fissures were surgically treated, he says, but the toxin approach antiquates the need for surgery. A one-time injection of 20 units of botulinum toxin will often suffice to close the fissure within only a few weeks to a few months time. Vestibulodynia can be a ver y debilitating condition characterized by chronic pain of the vulvar region, and it occurs without any identifiable cause or visible pathology. Patients will complain of severe pain every time they have contact with the vulvar area, and here, botulinum toxin can help to alleviate symptoms, Dr. Humbert says. Dr. Humbert has treated more than 30 patients with botulinum toxin for this condition, and he has achieved good outcomes regarding pain relief. At the three- and six-month follow-up after a 100 unit botulinum toxin treatment, he says he found that the pain was significantly reduced in his patients. DT Disclosures: Dr. Humbert reports no relevant financial interests. Getty Images/Science Photo Library/LAGUNA DESIGN 32 BREAKTHROUGH SCIENCE THAT TRANSFORMS SKIN HYDRATION Introducing Professional Repair, Eucerin’s first 3-dimensional system that sets a new standard in skin care, with a unique proprietary formulation that actively addresses the causes of xerosis Gluco-Glycerol — an enhanced glycerol derivative increases water content to the stratum corneum NMF — Natural moisturizing factor components bind and maintain water in the stratum corneum Ceramide 3 — designed to strengthen skin barrier function and minimize water loss NEW ©2012 Beiersdorf Inc. Dermatology Times clinical dermatology | May 2012 Perfect fit Topical combination therapies for psoriasis offer high degree of efficacy, safety By John Jesitus Senior Staff Correspondent Norfolk, Va. — Topical combina- tion treatments for psoriasis offer a high degree of clinical efficacy, patient safety and f lexibility in designing treatment regimens, says David M. Pariser, M.D. “Combination therapy in psoriasis is absolutely the standard of care,” says Dr. Pariser, professor of dermatology, Eastern Virginia Medica l School, and a Norfolk, “Both the American Academy of Dermatology and the National Psoriasis Foundation include combination therapy in their guidelines for psoriasis treatment.” David Pariser, M.D. Eastern Virginia Medical School Studies show that combination therapies for treating psoriasis provide a wide variety of advantages. Va., dermatologist in private practice. “Virtually all patients with psoriasis are treated with combination therapy. If they’re on systemic agents, there will often be a few spots that don’t respond as well. Therefore, topical therapies are important for virtually everyone who has psoriasis,” no matter how mild or serious their disease. “ To pi c a l c or t i c o s t e r oi d s i n one form or another, usually the more potent ones, are the most commonly prescribed topical agent for psoriasis,” he says. In addition, “There’s a lot of interesting data on combination therapy using vitamin D topica l ly, a long w it h topica l steroids.” Meta-analysis A recent meta-analysis of 50 randomized, controlled trials analyzed combination psoriasis treatments in comparison to monotherapies. When researchers stratified results by corticosteroid class, Dr. Pariser says, “They concluded that by adding a corticosteroid to a calcipotriene regimen, the likelihood of disease clearance increased by 28 percent for a Class 1 corticosteroid (95 percent confidence interval/CI: 16 to 41 percent) and 14 percent for a Class 2 steroid (95 percent CI: 5 to 22 percent; Bailey EE, Ference EH, Alikhan A, et al. Arch Dermatol. 2011 Dec 19. [Epub ahead of print]).” Compared to vitamin D derivative monotherapy, combining vitamin D with corticosteroids conferred a 22 percent higher likelihood of clearance, he says. “That’s a significant finding that supports the notion that we’ve all had clinically over many years that adding the corticosteroid to the vitamin D does make it work better, and over time can actually achieve clearance” in the percentages specified above, Dr. Pariser says. In two studies that contained sufficient data to analyze efficacy in terms of reductions in disease severity scores, investigators found that combination therapy with any Perfect fit see page 36 Getty Images/Photodisc/Studio 504/Photographer’s Choice RF/Gregor Schuster 34 36 Dermatology Times clinical dermatology | May 2012 PErFEcT FiT: Combo therapies for psoriasis of fer ef ficacy, safet y from page 34 corticosteroid class decreased disease severity by 1.52 units of standard deviation (95 percent CI: -2.56 to -0.48) versus vitamin D derivative monotherapy. Conversely, in the same meta-analysis, if patients used a Class 3 or weaker steroid in combination with topical vitamin D, it did not improve disease clearance compared with vitamin D derivative monotherapy, says Mark Lebwohl, M.D. Topical vitamin D preparations carry very few side effects, Dr. Pariser says. Product update Combination products available in the United States include a fixed combination of betamethasone dipropionate and calcipotriene, Dr. Pariser says. In a four-week study, the combination product worked better than either of its ingredients used separately, or its vehicle (Kaufmann R, Bibby AJ, Bissonnette R, et al. Dermatology. 2002;205(4):389-393). In this study, investigators randomized 1,603 patients to one of four double-blinded treatments: oncedaily combination ointment, betamethasone dipropionate ointment, calcipotriol (known as calcipotriene in the United States) ointment, or the ointment vehicle. When treatment ended, mean percentage improvements in Psoriasis Area and Severity Index (PASI) scores were 71.3 percent, 57.2 percent, 46.1 percent and 22.7 percent, respectively. Additionally, investigators concluded that the combination treatment was well tolerated: 6 percent of patients who used it experienced local adverse reactions, versus 4.9 percent of betamethasone dipropionate users, 11.4 percent of calcipotriol users and 13.6 percent of vehicle users. Patients a lso can accomplish combination regimens by purchasing topical steroid and topical vitamin D products separately, or having the combination compounded a compounding pharmacy, Dr. Pariser says. CI: 22 to 47 percent). Conversely, investigators found that vitamin D-UVB combination therapy did not confer a statistically significantly higher likelihood of clearance when compared to UVB monotherapy: the increased likelihood calculated among five studies of this type was 11 percent (95 percent CI: -2 to 24 percent). Options for regimens side effects Combination topical regimens can take various forms, says Dr. Pariser. For exa mple, a pu lsed regimen involves a brief period of intense steroid use followed by a period of vitamin D use. In contrast, sequential regimens consist of steroid followed by vitamin D, each for a predetermined, nonoverlapping time period. Alternating regimens can involve using a topical steroid in the morning, then topical vitamin D in the evening, or vice versa. Other regimens involve weekday/weekend alternation, Dr. Pariser says. “Those are both effective ways to do it. You can get about 80 percent of patients’ psoriasis to be mild or better by using the a.m./p.m. regimen. Patients can do perhaps not quite as well, with 60 percent to 70 percent achieving mild or better ratings, and perhaps up to 80 percent, by using the steroid on the weekends and vitamin D during the week,” he says. “That’s generally what most dermatologists do in terms of combination therapy. They’ll gravitate toward one of those approaches, or sometimes they’ll be able to use both of those regimens.” Topical vitamin D preparations carry very few side effects, Dr. Pariser says. These include minor irritation and the theoretical side effect of altered calcium metabolism as a result of covering too much of the skin’s surface with vitamin D analogues. “But even in the clinical trials, that has never manifested itself,” he says. Side effects of topical steroid overuse include local skin atrophy, striae, telangiectasias, and, with extreme overuse, the possibility of systemic absorption and adrenal suppression. “However, with the quantities that we would normally use for treatment of psoriasis, those are not really an issue,” he says. Accordingly, “Both the American Academy of Dermatology and the Nat iona l Psor iasis Fou ndat ion include combination therapy in their guidelines for psoriasis treatment,” Dr. Pariser says. One of the first publications to highlight the synergistic effects of combining topical steroids and vitamin D appeared 16 years ago (Lebwohl M, Siskin SB, Epinette W, et al. J Am Acad Dermatol. 1996;35(2 Pt 1):268-269.), he adds. DT Phototherapy As for the impact of combining phototherapy and topical vitamin D, the meta-analysis mentioned above found that two studies had sufficient data to draw conclusions regarding clearance efficacy. In this regard, the combination of vitamin D derivative and UVB therapy increased the likelihood of clearance by 34 percent versus vitamin D derivative monotherapy (95 percent Disclosures: Dr. Pariser has performed clinical trials for all makers of topical vitamin D analogue products available in the United States, and for the maker of the steroid/calcipotriene combination product (LEO Pharma). However, he is not a speaker or consultant for any of these companies. May 2012 | SPECIAL REPORT DermatologyTimes.com 40 42 44 Better together 39 skin Ipilimumab, radiotherapy target metastatic melanoma cancEr Keep it simple Ingenol mebutate gel works quickly, easily for AK patients Closer look Photoacoustic devices help guide lesion biopsy decisions Expanding options Novel melanoma therapies portend a ‘golden age’ of cancer care By Paula Moyer Staff Correspondent National report — Several newly approved therapies have changed and are continuing to change the treatment of melanoma therapy so that it is no longer the “black sheep” of cancer therapy, according to Adil Daud, M.D. “These treatments have made a tremendous difference to the treatment of melanoma,” says Dr. Daud of what he calls “game-changing” therapies such as vemurafenib (Zelboraf, Genentech) and ipilimumab (Yervoy, Bristol-Myers Squibb). Dr. Daud is co-director, Melanoma Program, University of California, San Francisco. “In 2010, when I would see a patient with melanoma, I would say the likelihood of response was 20 percent. That meant most patients would progress (even) on treatment,” he says. Broadened options Getty Images/Studio ZooCollection/Imagezoo/Scott Heiner/iStock Vectors Two melanoma experts concurred w it h Dr. Daud’s assessment. Newly approved drugs such as vemurafenib and ipilimumab are creating a “game-changing” era for treatment of metastatic melanoma, clinicians say. “Both of these agents have changed our options,” says Edward S. McClay, M.D., a medical oncologist in private practice in San Diego, and director, Institute for Melanoma Research and Education, California Cancer Associates for Research and Excellence. The genetic mutation that many melanoma patients have is a type of rapidly accelerating fibrosarcoma (RAF) involving serine/threonineprotein kinase B, known as BRAF. “Vemurafenib is designed to interr upt t he BR AF pathway,” Dr. McClay says. DT Extra DT High ExtraSPF sunscreens effective Sunscreens with sun protection factors of 70 or higher provide adequate protection against photodamage and skin cancer, even with irregular application, according to a study published in the Journal of the American Academy of Dermatology. Researchers with Neutrogena measured actual SPF values of six sunscreens, SPF 30 to 100. Sunscreens with SPF 70 and 100 resulted in actual SPF values of 19 and 27, respectively. A linear relationship existed between application density and actual SPF, researchers found. Source: HealthDay News “For patients who have this mutation, there is a 50 to 60 percent chance of a response.” “Clearly, those two drugs have created a huge shift in the way we are going to manage melanoma,” says Arkadiusz Dudek, M.D., Ph.D. He is associate professor of oncology, University of Minnesota, Minneapolis, where he heads the solid tumor oncology group of the Cancer Experimental Therapeutics Initiative at the Masonic Cancer Center. “Before they were approved, we only had one chemotherapy with very little ability to control this disease. High-dose interleukin-2 is also very limited. These two drugs are the result of our understanding better the biology of melanoma,” Dr. Dudek says. This improved understanding has led investigators to understand that BRAF-mutation melanoma will eventually develop resistance to vemurafenib. “We are already developing the drugs to delay resistance to vemura fenib,” Dr. Dudek says. “ The Drug development see page 46 Quotable “Patients with metastatic melanoma have a lot more hope now than they had previously.” Michael A. Postow, M.D. New York On combining ipilimumab with radiotherapy See story, page 40 40 Dermatology Times SPECIAL REPORT | May 2012 skin cancEr potent combo Radiotherapy boosts efficacy of ipilimumab in metastatic melanoma By Diane Angelucci Staff Correspondent New York — Although ipilimumab (Yervoy, Bristol-Myers Squibb) has been a tremendous advance for patients with metastatic melanoma, only a subset of patients benefits from treatment. As researchers continue to study the effects of adjunctive therapies with ipilimumab, however, a recent report suggests radiotherapy may increase its efficacy, according to Michael A. Postow, M.D., medical oncology fellow, Memorial SloanKettering Cancer Center, New York. “It wasn’t until the radiation was delivered that her tumors started to regress and decrease in size.” Michael A. Postow, M.D. New York reported case Dr. Postow is part of a team led by medical oncologist and immunologist Jedd D. Wolchok, M.D., Ph.D., that reported in the New England Journal of Medicine a case of a woman with metastatic melanoma (Postow MA, Callahan MG, Barker CA, et al. N Engl J Med. 2012;366(10):925-931). The patient had been enrolled in a Although ipilimumab has shown promise in treating metastatic melanoma, only a subset of patients benefits. Radiotherapy combined with the drug, however, may be efficacious in some patients. clinical trial and treated with ipilimumab as part of her treatment, which failed to halt the spread of the disease. However, after she received palliative radiotherapy for back pain resulting from a paraspinal mass, her targeted paraspinal mass as well as lesions outside the irradiated area remarkably regressed. “What made this case particularly interesting to us is that this is the first time that we have seen that there was a clear, documented case where someone really benefited with a combination of radiotherapy when it was administered with ipilimumab,” Dr. Postow says. Researchers hope this finding will lead to further investigation of possible mechanisms of synergy between the two anticancer treatments and potentially increase the number of patients benefiting from ipilimumab. The patient’s response after radiotherapy hinted that radiotherapy may have boosted the efficacy of ipilimumab. “It’s a little bit different in our patient because she had been getting ipilimumab for quite a long time, and it hadn’t been working as we had been hoping, in that her tumors were slowly increasing in size,” Dr. Postow says. “It wasn’t until the radiation was delivered that her tumors started to regress and decrease in size,” he says. The medical literature reports a rare occurrence known as the abscopal effect, resulting in regression of tumors outside the irradiated area when radiotherapy is targeted to one tumor area, Dr. Postow says. role of the dermatologist Dr. Postow urges caution in interpreting these results. “I think this case report generates great enthusiasm for the concept and the possibility of synergy between these two treatment modalities,” Dr. Postow says. “But before we move forward too definitively with these thoughts, I think that this needs to be tested more rigorously in a prospective clinical trial.” Dr. Postow says he believes these findings are promising, however. “I think what’s important for dermatologists to know about this is this exciting possible combination and ipilimumab in general have dramatically changed the treatment of metastatic melanoma,” he says. “Patients with metastatic melanoma have a May 2012 | SPECIAL REPORT DermatologyTimes.com lot more hope now than they had previously.” Dermatologists are often the first physicians patients encounter when they are diagnosed with melanoma, so they need to understand all of the new treatment modalities and how to counsel patients before referral for medical or surgical oncology evaluation. “ These patients a re of ten quite reasonably anxious when faced with this initial diagnosis that they are typically discussing first with their dermatologist,” Dr. Postow says. Researchers believe one component of ipilimumab differs from other anticancer treatments. In a small group of patients, their disease disappears or remains stable for many years, Dr. Postow says. “It’s enticing to imagine that there’s a concept of cure for a small group of patients,” he explains. “This is what is driving much of the enthusiasm for this medication.” Less than 50 percent of patients benefit from the drug, however, and a phase 3 trial reported a median survival of 10 months for previously treated patients with advanced melanoma (Hodi FS, O’Day SJ, McDermott DF, et al. N Engl J Med. 2010;363(8):711-723), he says. “So certainly there’s room to go, for sure,” he says. “But the key component of that is, there is a small slice of this population of patients that get this medicine that do quite well for many, many years, some of whom have all of their tumors go away,” he continues. Dr. Postow cautions against placing too much weight on one case. “What I do think is that if there are any patients that need ipilimumab and have a need for palliative radiotherapy independently, there is a possibility of synergy when delivered together,” he says. “We don’t believe that there’s any particular hazard in trying that combination for the appropriate patient, although we await the results of more rigorous prospective trials to be more definitive in any kind of recommendation for practice,” Dr. Postow says. In this regard, however, he says dermatologists may play an important role by obtaining tissue biopsies from willing patients to help medical and surgical oncologists understand how the immune system is either eradicating or not eradicating tumors and which tumor features may be responsible for resistance to the immune system. 41 “Cooperation in that regard may really help advance our understanding of this disease,” he says. DT Disclosures: Dr. Postow reports no relevant financial interests. ,QWKHÀUVWOLQHWUHDWPHQWRIH[WHUQDOJHQLWDODQGSHULDQDOZDUWV(*:« Put patients in the clear. 9(5(*(1®'HOLYHUV &RPSOHWH &OHDUDQFH:LWK /RZ5HFXUUHQFH*1 RISDWLHQWVGHPRQVWUDWHGFRPSOHWHFOHDUDQFH1 ³2QO\RISDWLHQWVZLWKFRPSOHWHFOHDUDQFHH[SHULHQFHGUHFXUUHQFHDWZHHNV posttreatment1 6LQHFDWHFKLQV2LQWPHQWLVQRZLQFOXGHGLQWKH&HQWHUVIRU'LVHDVH&RQWURODQG 3UHYHQWLRQ&'&6H[XDOO\7UDQVPLWWHG'LVHDVHV7UHDWPHQW*XLGHOLQHV —Listed as a patient-applied treatment option for EGW 7KHPRVWFRPPRQDGYHUVHUHDFWLRQVZHUHORFDOVNLQDQGDSSOLFDWLRQVLWHUHDFWLRQV1 $WZHHNVSRVWWUHDWPHQWLQWKHWZRSKDVHVWXGLHV VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Important Selected Safety Information VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds. Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed patients or patients under 18 years of age, or pregnant women, or for the treatment The FIRST of external genital and perianal warts %27$1,&$/'58* approved for prescription beyond 16 weeks or for multiple use in the United States treatment courses. The most common adverse reactions are local skin and application site reactions LQFOXGLQJLQFLGHQFHHU\WKHPD pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, and rash vesicular. 5HIHUHQFHV VEREGEN®2LQWPHQW>3UHVFULELQJ,QIRUPDWLRQ@0HOYLOOH1<3KDUPD'HUP a division of Fougera Pharmaceuticals Inc. :RUNRZVNL.$%HUPDQ6&HQWHUVIRU'LVHDVH&RQWURO DQG3UHYHQWLRQ6H[XDOO\WUDQVPLWWHGGLVHDVHVWUHDWPHQWJXLGHOLQHVMMWR Recomm Rep. 55'DWDRQÀOH3KDUPD'HUP Please see adjacent page for Brief Summary of full Prescribing Information. 9(5(*(1LVDUHJLVWHUHGWUDGHPDUNRI0HGL*HQH$*'3ODQHJJ0DUWLQVULHG*HUPDQ\ 3KDUPD'HUPDGLYLVLRQRI)RXJHUD3KDUPDFHXWLFDOV,QF0HOYLOOH1<$OOULJKWVUHVHUYHG19( 42 Dermatology Times SPECIAL REPORT | May 2012 AK alternative Ingenol mebutate gel provides easy-to-use treatment option skin cancEr By Louise Gagnon Staff Correspondent New York — The approval of ingenol mebutate gel presents an easy-to-use option to treat actinic keratoses (AKs), but the flexibility in dosing of a treatment like imiquimod will ensure its place in the armamentarium of AK treatments, according to the professor and chairman of the department of dermatology, Mount Sinai School of Medicine, New York. “There is a big need for a drug that works quickly,” says Mark Lebwohl, M.D., who has conducted studies on ingenol mebutate gel (0.015 percent for face and scalp; 0.05 percent for trunk and extremities), which is known by the brand name Picato (LEO Pharma). “All of the drugs are either very irritating or somewhat irritating, and they have to be used for a longer period of time. Most patients want to get treatment over with quickly rather than slowly.” Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com ® Veregen (sinecatechins) Ointment, 15% Rx Only For Topical Dermatologic Use Only Nursing Mothers It is not known whether topically applied Veregen® is excreted in breast milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects. ADVERSE REACTIONS INDICATIONS AND USAGE Veregen® is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Limitations of Use: Safety and effectiveness of Veregen® have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses. CONTRAINDICATIONS None CLINICAL STUDIES Two randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment). Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30). The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication. Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397) 213 (53.6%) Vehicle (N = 207) 73 (35.3%) United States ® Veregen 15% (N = 21) 5 (23.8%) Vehicle (N = 9) 0 (0.0%) Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205) 97 (47.3%) Vehicle (N = 118) 34 (28.8%) Females Veregen® 15% (N = 192) 116 (60.4%) Vehicle (N = 89) 39 (43.8%) Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials. The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle. WARNINGS AND PRECAUTIONS Veregen® should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease. Use of Veregen® on open wounds should be avoided. Avoid exposure of Veregen® treated areas to sun/UV-light as Veregen® has not been tested under these circumstances. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks. Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers. Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%). A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only. Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle. The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment. Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia. In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions. DOSAGE AND ADMINISTRATION Veregen® is to be applied three times per day to all external genital and perianal warts. Apply about an 0.5 cm strand of ointment to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Veregen® is not for ophthalmic, oral, intra-vaginal, or intra-anal use. HOW SUPPLIED/STORAGE AND HANDLING Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube. Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze. Manufactured for: Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany U.S. Patent Nos. 5795911 and 5968973 98NVE060312 While imiquimod remains a go-to therapy for actinic keratosis, ingenol mebutate gel serves as a substitute that works quickly and is easy for patients to use, a clinician says. The therapy is derived from the active ingredient in the sap of the plant Euphorbia peplus, regarded as a traditional remedy for common skin lesions. Many current therapies for AKs, which are precursors to squamous cell carcinoma, have to be used for long periods of time and are either somewhat or very irritating, according to Dr. Lebwohl. topical comparisons Ingenol mebutate gel 0.015 percent is used once daily on the face and scalp for three consecutive days, while the 0.05 percent concentration is used daily on the trunk and extremities for two consecutive days. Imiquimod 3.75 percent therapy, by contrast, requires a six-week dosing cycle consisting of once-daily, two weeks on, two weeks off, and another two weeks of daily treatment, for AKs that present on the face and scalp. The therapy is indicated for application to surface areas larger than 25 cm 2 , whereas ingenol mebutate is not. The therapy needs to stay on the face for eight hours. Applied in a less accelerated dosing schedule than imiquimod 3.75 percent, imiquimod 5 percent cream is applied in a number of regimens with the approved regimen being two applications per week for four months. Like ingenol mebutate, it is indicated to be applied to a contiguous area less than 25 cm2. A topical therapy such as imiquimod offers patients flexibility of dosing, Dr. Lebwohl says. With Zyclara (imiquimod, May 2012 | SPECIAL REPORT DermatologyTimes.com Medicis) cream 3.75 percent now available in another delivery model, a pump rather than packets, it will allow patients the opportunity to increase the amount of the therapy they apply to the skin, he says. “You are not limited to the amount that you use whereas you are with a packet,” he says. “You can dispense more (and cover a wider area).” Dr. Lebwohl describes the results of treatment with either ingenol mebutate or imiquimod as “amazingly comparable” and adds that the therapies are also comparable in terms of their ability to reduce recurrence of AKs. treatment outcomes Mo s t re c e nt l y, D r. L e bwoh l a nd co-investigators published data in March in the New England Dr. Lebwohl Journal of Medicine f rom fou r mu lt icenter, randomized, double-blind studies where patients were randomly assigned to receive eit her ingenol mebutate or placebo (Lebwohl M, Swanson N, Anderson LL, et al. N Engl J Med. 2012;366(11):1010-1019). They observed statistically significant differences in the rate of complete clearance of AKs on the face and scalp between ingenol mebutate and placebo, 42.2 vs. 3.7 percent, p<0.001, and on the trunk and extremities, 34.1 vs. 4.7 percent, p<0.001. Both therapies can cause local skin reactions such as erythema, scabbing, crusting, flaking, scaling and dryness, Dr. Lebwohl says. In addition, swelling around the eyes can occur. For isolated lesions, Dr. Lebwohl says most AKs are treated with cryotherapy, but a field therapy is typically employed to treat multiple lesions that are present. Although most AKs do not develop into invasive squamous cell carcinomas, the relative risk of developing SCCs increases with the number of AK lesions. The ability, therefore, of a therapy to treat not only clinically visible lesions but also subclinical disease is significant. Both ingenol mebutate and imiquimod can act as field treatments, Dr. Lebwohl says. “They both clear fields very effectively,” he says. Cost and reimbursement of a therapy ultimately determine what therapy is used to treat AKs, he says. Older thera- pies such as fluorouracil, also referred to as 5-FU, or diclofenac are typically used before newer therapies such as imiquimod or ingenol mebutate. “Insurance companies, to a large degree, determine what we use (to treat AKs),” Dr. Lebwohl says. “It (5-FU) is quite irritating, and the treatment lasts for weeks. Compliance is a challenge because of skin irritation and how long the therapy needs to be applied.” In i mmu nocompromised pat ients, imiquimod as a therapy to treat AKs has been studied to be both safe and effective while ingenol mebutate has not been tested in populations of patients who have undergone organ transplants. DT Disclosures: Dr. Lebwohl is a paid consultant for LEO Pharma. STRENGTH TO PERFORM SAVE UP TO $4,240 430 SERIES QUAD-POWER PROCEDURE TABLE QDETAILS Purchase an MTI 430 Series Table and a Centurion Standard Single 43,000 Lux Surgery Light between February 1, 2012 and June 30, 2012, with delivery taken by July 31, 2012 and receive FREE Programmability and a 5-caster Aire Ride Stool. Upgrade to the NEW MI-1000 LED 64,500 Lux Light which is almost heat free, brighter, dimmable, and has LEDs that last up to 50,000 hours. QTIME This promotion is only valid for invoiced sales from February 1, 2012 to June 30, 2012, with delivery taken no later than July 31, 2012. QQUESTIONS For more information on this promotion or inquiries about the MTI 430 Series Procedure Table, please call MTI’s Sales Department at (800) 924-4655 or visit our web site at www.mti.net. 3655 West Ninigret Drive, Salt Lake City, Utah 84104 tt'BY www.mti.net Strength in patient care.™ Model 430 Optional plush upholstery shown 43 44 Dermatology Times SPECIAL REPORT | May 2012 skin cancEr id assistance Photoacoustic devices help clinicians to determine which lesions to biopsy By Paula Moyer Staff Correspondent New York — Newly available photo- acoustic devices can help dermatologists identify which pigmented lesions to biopsy, according to Darrell S. Rigel, M.D., M.S. Such devices only aid the trained specialist in the assessment of such lesions, however, and do not substitute for the professional, he says. “Nothing replaces a good set of eyes,” says Dr. Rigel, clinical professor of dermatology, New York University Medical Center. “Typically, patients come in with multiple lesions, and you have to determine which to biopsy. That’s where the devices come in. They give you another piece of information to help you with the biopsy decision.” “Typically patients come in with multiple lesions, and you have to determine which to biopsy. That’s where the devices come in.” Darrell S. Rigel, M.D., M.S. New York University Medical Center The various digital programs that have developed in the 21st century use different mechanisms to identify pigmented lesions that are suspicious for melanoma. The most recent to be approved, MelaFind (MELA Sciences), obtains data about atypical pigmented lesions about atypical pigmented lesions from up to 2.5 mm below the cutaneous surface. New photoacoustic screening devices will facilitate clinicians’ decision-making regarding which pigmented skin lesions to biopsy. All involve some learning curve, however, and none replace a dermatologist’s trained eye. It uses 10 wavelengths varying from 450 nm to 950 nm and can visualize lesions as small as 20 µ in diameter. The system then incorporates the data into an algorithm that makes a biopsy recommendation and displays the suspicious lesion in the various wavelengths. Formulas and thresholds “The new digital systems all work differently,” Dr. Rigel says. “Some enter the data into an algorithm automatically, while some require that the operator enter the information. Some require so much manual input that by the time you enter the data, you know whether or not to biopsy the lesion.” Some require skilled technologists, while others are virtually operatorindependent, he says. Some, such as MelaFind, gather information with light while others utilize ultrasound or genetic analysis. “The idea behind it is to determine whether a biopsy is necessary, and they all work on formulas,” Dr. Rigel says. The formula will score the lesion so that lesions above a certain threshold get a biopsy recommendation while those below that threshold will be considered benign and therefore not needing a biopsy. Because the worst scenario is to miss a melanoma, all of the devices are adjusted to increase the sensitivity of detecting a melanoma, he says. S e ve r a l ne w d e v ic e s s hou ld become available in the next few years, Dr. Rigel says, noting that the approval of Verisante Aura (Verisante Technology) is expected soon. Verisante Aura takes advantage of the principle that melanoma lesions have a different vibrational frequency than healthy tissue when visualized by monochromatic light. The system utilizes multiple biomarkers for melanoma and other skin cancers to identify lesions for biopsy. A l l of t he de v ic e s i nvolve a learning curve, Dr. Rigel says. “You can’t teach in a short training session which lesions to image,” he says. “Dermatologists will still have to have the primary judgment in making the biopsy decision.” in the pipeline Other systems currently in the investigational pipeline will be of interest to dermatologists as well. One system utilizes mRNA information from suspicious moles. The dermatologist puts tape on the tested mole. When the tape is removed, the mRNA on the tape is analyzed. The results still take several days to come back to the dermatologist, however. Another system utilizes a probe placed on both sides of the mole and takes advantage of the fact that melanoma cells differ in their electrical resistance from healthy cells. Biopsy decisions see page 46 PROS TRUST How do you get to be a household name in Dermatology? The Personna DermaBlade® is the name for the highest quality product of its kind available. Designed for shave biopsies, it has a unique look and feel that will make your job easier than ever. The Personna DermaBlade's flexible design provides the sharpest blade available, while our MicroCoat® technology reduces tissue trauma. Special side grips allow for a three digit grip for extra control and make it a snap to pick up. Each DermaBlade is packaged to guarantee sterility and complete protection. And DermaBlade is disposable, for added safety. So use the product that Dermatologists swear by. DermaBlade by Personna. To learn more, visit us at personnablades.com Personna DermaBlades are the sharpest on the market. Our exclusive MicroCoat® coating process allows blades to glide with smooth, clean precision. © 2012 Personna. All rights reserved. 46 Dermatology Times SPECIAL REPORT | May 2012 skin cancEr drug dEvElopmEnt: New approvals augment cancer therapy options potential for broadened treatment options created a lot of interest in new approaches to treating melanoma, such as combining drugs, determining which drug to use first, whether to use high-dose IL-2 first.” cost may be barrier Dr. Daud cautions that the new therapies come with encumbrances of cost and adverse effects. The high cost of the new treatments is particularly worrisome, he says. Vemurafenib costs approximately “I’m very concerned that drug companies are pushing the boundaries with these prices. We risk a regulatory backlash.” Adil Daud, M.D. University of California, San Francisco $9,400 per month, with a treatment typically lasting approximately six months, or a total cost of $56,400. Ipilimumab costs approximately $30,000 per infusion, so that a full course, consisting of four infusions in a three-month period, costs $120,000. The specter of significant treatment barriers is obvious and serious, according to Dr. Daud. “I’m very concerned that drug companies are pushing the boundaries with these prices,” he says. “We risk a regulatory backlash.” from page 39 One potential affordability issue that can arise is that some insurance companies don’t consider vemurafenib a cancer therapy because it is administered orally, and therefore they categorize it as a prescription drug, Dr. McClay says. “For patients with a 20 percent co-pay, that approach can make the cost of care prohibitive,” he says, but he notes that the manufacturer often finds ways to help patients with affordability issues. adverse effects Further, these drugs are associated with adverse effects with which clinicians are struggling to familiarize themselves. For example, Dr. Daud says vemurafenib is associated with squamous cell cancer and excessive photosensitivity. Therefore, in his practice, patients on vemurafenib see a dermatologist monthly. Ipilimumab is associated with autoimmune colitis and hormone deficiency syndromes. “Both these drugs have unusual side effects with some learning curves,” he says. The adverse effects associated with these therapies differ from the typical chemotherapy-related effects, clinicians using them need to know how to manage them, Dr. Dudek says. For example, the hypersensitivity and photosensitivity associated with vemurafenib necessitate collaboration between oncologists and dermatologists. The autoimmune effects associated with ipilimumab, such as colitis and rashes, should also be on the radar of clinicians using this therapy. However, these hurdles need to be seen in the broader context of their overall contributions to melanoma treatment, Dr. Daud says. “This is a golden age for melanoma therapy,” he says. the place for vismodegib? Dr. Daud was less optimistic about a role for vismodegib (Erivedge, Genentech/Roche), recently approved for the treatment of metastatic basal cell carcinoma. “This is a modest advance clinically because metastatic basal cell carcinoma is very rare,” he says. While metastatic basal cell carcinoma is relatively rare, Dr. McClay says he saw a role for vismodegib in patients who have large tumors in difficult areas, such as the face, where surgical removal could create intolerable defects. Vismodegib can also shrink such lesions to a resectable size, and may expand options for patients with multiple recurrences. “It provides us with an option not there before,” he says. DT Disclosures: Dr. Daud has received research funding from Roche, GlaxoSmithKline and Pfizer. He has consulted for and Bristol-Myers Squibb and Merck. He reports no financial shares or other interests. Dr. McClay is a speaker for Genentech/Roche, but he owns no stock the company. Dr. Dudek reports no relevant financial interests. Biopsy dEcisions: Photoacoustic devices help to guide actions from page 44 a discerning look should also learn from a variety of the meantime, Dr. Rigel says dermaWhen new devices become available, Dr. Rigel urges dermatologists to be discerning. “We need to know how a device is tested to validate it,” he says. “The original data set where the device learns from the lesions should be from multiple centers and consist of at least 1,000 pigmented lesions.” The validating data set should also be at least 1,000 pigmented lesions and consist of different lesions from the original set, he says. The system lesions. “If it is only exposed to advanced melanomas, it would be easy to test,” Dr. Rigel says. At their best, the new devices will help dermatologists to be more accurate. When tested without such aids against data sets of pigmented lesions, dermatologists correctly identify 80 percent of melanomas, while primary care physicians’ accuracy rate is 20 percent, he says. Eventually, some systems will prove to be superior to the others. In tologists need to know the quality of science behind any digital screening system they are considering for their own practices. DT Disclosures: Dr. Rigel has consulted for MELA Sciences, developing digital systems for screening pigmented skin lesions. He reports no other relevant financial interests. For more information: Rigel DS, Russak J, Friedman R. CA Cancer J Clin. 2010;60(5):301-316. May 2012 | cosmetic dermatology DermatologyTimes.com 50 53 49 cosmetic conundrums Skin assessment Pigment measurement tool boosts safety of laser device Zoe Diana Draelos, M.D., is a Dermatology Times editorial adviser and consulting professor of dermatology, Duke University School of Medicine, Durham, N.C. Questions may be submitted via email to [email protected]. Injecting synergy Newer technologies address facial aging in patients of color DNA discoveries Exploring theories, potential opportunities of gene-matched cosmetics Q Is it possible to design a cosmetic to match a patient’s genes? Getty Images/Science Photo Library/PASIEKA a: One new marketing concept is to design boutique cosmetics that complement the genes of the consumer. This idea builds on the current genomic approach to cosmeceutical research where gene expression is being used to study the effect of ingredients on the skin. Problems arise when extrapolation is made from one individual gene in one cell turning on at a molecular level and the appearance of the skin. The behavior of many, many, many cells must be influenced for the skin to undergo a change observable by the cosmetic user. It actually is unknown how single genetic changes translate into appearance changes. It is possible to design a cosmetic to match a patient’s genes, but it’s uncertain exactly what this means. Some companies have the consumer fill out a questionnaire regarding skin type, eye color, hair color, tendency to sunburn, lifestyle habits, ethnicity, degree of photodamage, etc. Much of the information needed to recommend a skin care regimen can be obtained from this type of questionnaire because the ability to fit specific ingredients to specific skin needs really has not evolved to the genetic level. DT Extra A buccal mucosal swab may also be submitted supposedly with the consumer’s DNA, but how this is processed and analyzed is subject to controversy. There have been some Federal Trade Commission inquiries into this process. Sequencing the genome of an individual is expensive, and specific markers for certain skin conditions are still beyond the reach of current technology. Designing cosmetics to meet specific genetic needs may still be more marketing hype than practical reality. Q How effective are the new at-home blue light devices for treating acne? a: Several devices have been introduced into the at-home market for treating acne. Some of the devices simply use resistive heating to warm the acne lesion. While corporate studies show a reduction in acne lesion healing time by two days, it is hard to do a controlled study of acne lesions because they heal without intervention. These heating devices claim to speed acne lesion healing, but they are not preventative. This is in contrast to the blue light devices that do not claim to speed acne lesion healing, but prevent the development ICG laser clears leg veins Telangiectatic leg veins treated with indocyanine green (ICG)-augmented diode laser therapy achieve good clearance, according to a study published in Lasers in Surgery and Medicine. Researchers with University Hospital Regensburg, Germany, gave ICG intravenously in 15 female patients, and then applied diode laser pulses with different radiant exposures. Diode laser treatment at radiant exposures of 100 J/cm2 to 110 J/cm2 led to good clearance. Source: HealthDay News of new acne lesions. Blue light energizes the porphyrins in Propionibacterium acnes (P. acnes) organisms and kills the bacteria that may be responsible for acne, however, newer theories of acne etiology indicate that the P. acnes may be a bystander and not an initiator of acne. This may explain why blue light does not cure acne. It has been demonstrated that blue light can improve acne, but the home use devices have some challenges. The devices are to be used with goggles similar to those used in tanning booths, which provide limited vision. The device must be stroked over the face for prevention and held over the individual acne lesions for treatment. It is estimated that this procedure takes 30 minutes for each side of the face, making total treatment time around one hour. Of course, this may vary depending on the number of acne lesions, the size of the face, the severity of acne, the size of the blue light aperature, and fluence of the light device. Most device studies have demonstrated results similar to topical benzoyl peroxide. Home blue light devices are a newcomer to the over-the-counter acne treatment market, and further data accompanied by design improvements may be forthcoming. DT Quotable “I tend to work with lower doses of neuromodulators, in conjunction with fillers.” Hema Sundaram, M.d. Washington On combining treatments for patients of color See story, page 53 50 Dermatology Times cosmetic dermatology | May 2012 light on lasers Joely Kaufman, M.D., is in private practice at Dr. Brandt Dermatology Associates and a voluntary assistant professor, University of Miami Department of Dermatology & Cutaneous Surgery. Jeremy Green, M.D., is in private practice at Dr. Brandt Dermatology Associates and a voluntary assistant professor, University of Miami Department of Dermatology & Cutaneous Surgery. Elizabeth R. Geddes, M.D., a resident at the University of Texas Health Science Center, Houston Medical School. Melanin insights Pigment measurement tool can increase safety, efficacy of light-based devices T he primary goal of the dermatologic laser surgeon is to deliver effective treatments without compromising patient safety. Laser and light-based technologies continue to evolve at a torrid pace, whereas the methodology by which laser surgeons assess the skin to be treated has lagged behind. Fitzpatrick’s eponymous skin-typing scale was introduced in 1975 to aid in determining therapeutic UVA light doses for oral methoxsalen photochemotherapy in white patients typed I to IV (Fitzpatrick TB. J Med Esthet. 1975;2:33034). Later expanded to include darker skin types, his system is a subjective assessment based on genetic disposition (eye, hair and skin color as well as freckling), tanning habits and reaction to sun exposure that, when combined with the laser surgeon’s therapeutic experience, dictate device treatment parameters (Fitzpatrick TB. Arch Dermatol. 1988;124(6):869-871). Melanin absorbs light over a broad spectrum, most avidly in the ultraviolet domain, and its absorbance decreases through the near-infrared spectrum. Patients with darker skin and higher melanin density are at increased risk of injury when they are treated with light energy in the visible and near-infrared spectrum. Thus, the pretreatment skin type assessment is absolutely crucial to ensure procedural safety. There are some commercially available noninvasive devices that aim to reduce the subjectivity of skin-type assessment by quantifying the amount of melanin in the skin. Due to their costs, cumbersome design, and inability to reliably distinguish between erythema and The primary goal of the dermatologic laser surgeon is to deliver effective treatments without compromising patient safety. melanin, however, these devices have primarily been employed for research. In previous investigations, such devices have been used to objectively measure skin color and determine the efficacy of lightening agents on melasma (Shin JW, Choi SY, Park KC. J Dermatol. Epub 2 Dec 2011) and lentigines (Yoshimura K, Harii K, Aoyama T, et al. Aesth Plast Surg. 2001;25(2):129-133). They have also been found useful in differentiating vitiligo from nevus depigmentosus (Park ES, Na JI, Kim SO, et al. Skin Res Technol. 2006;12(4):298302), as well as in evaluating treatment response of these conditions to narrow band UVB therapy (Hwang SW, Kang JH, Jung SO, et al. Ann Dermatol. 2010;22(4):482-485). The majority of these products utilize reflectance spectroscopy, which operates on the premise that two main chromophores contribute to skin color — melanin and hemoglobin. Light is delivered to the target surface via a probe and a photodetector is used to collect the reflected light. The more melanin in the skin, the less light reflected. However, in order to account for the contribution of hemoglobin, more than one spectral band must be assessed (Stamatas GN, Zmudzka BZ, Kollias N, Beer JZ. Pigment Cell Res. 2004; 17(6):618-626). Current classes The two main classes currently in use are the tristimulus reflectance colorimeters, which include the Minolta Chroma Meter and Photovolt ColorWalk, and the narrowband reflectance spectrophotometers, examples of which are the Cortex Technologies DermaSpectrophotometer and the Courage+Khazaka Mexameter. The tristimulus colorimeters emit white light and use a photodiode or specific wavelength filters to measure the intensity of the reflected light, which is analogous to the way the human eye detects color — shades of red, green and blue. Results are conveyed in a standardized color system, L* (lightness/darkness), a* (green/red), b* (yellow/blue), with L* and b* values most often used to express pigment. Narrowband spectrophotometers utilize the fact that melanin and hemoglobin have different spectral curves for light absorption. Hemoglobin has a large peak in the green light wavelengths with little absorption of red light wavelengths, and melanin readily absorbs red light. The reflectance of narrowband red light can provide an estimate of the amount of melanin in the skin (Taylor S, Westerhof W, Im S, Lim J. J Am Acad Dermatol. 2006;54(5 Suppl 2):S282-S290). Spectrophotometers use light emitting diodes (LED) of specific wavelengths and express the computed results in melanin and erythema indices. One example May 2012 | is the Mexameter, which uses the intensity of absorbed and reflected light at 660 nm (red) and 568 nm (green) for erythema and 660 nm (red) and 880 nm (near-infrared) for melanin (Clarys P, Alewaeters K, Lambrecht R, Barel AO. Skin Res Technol. 2000;6(4):230238). Readings of 0 and 999 correspond to white and black, respectively. A few clinical studies have compared these two types of devices. Shriver and Parra found a strong correlation between the melanin index (MI) and L* value and concluded that both devices provide accurate measurements of skin and hair color in persons of European, Asian and AfricanAmerican ancestry (Shriver MD, Parra EJ. Am J Phys Anthropo. 2000;112(1):17-27). In a comparison of the tristimulus chromameter and the narrowband spectrophotometers the Mexameter and the DermaSpectrophotometer for evaluation of various skin color changes (erythema, irritation, blanching, artificial and UV tanning), it was found that the sensitivity and reproducibility of all devices were good. The Mexameter showed the weakest sensitivity, but the day-to-day repeatability of melanin measurements was better for the narrow band spectrophotometers (Clarys P, Alewaeters K, Lambrecht R, Barel AO. Skin Res Technol. 2000;6(4):230-238). One of the more challenging considerations when measuring changes in pigment is how to minimize the confounding effects of erythema that can occur with both bleaching regimens and phototherapy. The narrowband spectrophotometers may be more appropriate in this situation (Yoshimura K, Harii K, Aoyama T, et al. Aesth Plast Surg. 2001;25(2):129-133) and have shown to be less affected by increased redness of certain body sites secondary to higher vascularization (Shriver MD, Parra EJ. Am J Phys Anthropo. 2000;112(1):17-27). Efforts should be made to keep environmental conditions constant in position and temperature and the probe held correctly to avoid pressure and blanching (Taylor S, Westerhof W, Im S, Lim J. J Am Acad Dermatol. 2006;54(5 Suppl 2):S282-S290). New to the market The latest entry into this device class is the Skintel Melanin Reader (Palomar Medical Technologies). The Skintel is a narrow-band spectrophotometer consisting of LED lights of three wavelengths (640 nm, 700 nm, 910 nm). The device measures skin reflectance based on epidermal thickness, wavelength and average absorption coefficient to obtain a value called the melanin optical density light on lasers see page 52 51 cosmetic dermatology DermatologyTimes.com One of the more challenging considerations when measuring changes in pigment is how to minimize the confounding effects of erythema that can occur. For the symptoms of psoriasis and severe eczema 6JGUVTGPIVJ QHCJKIJRQVGPE[ UVGTQKFKPCOQKUVWTK\KPI DCUG t Diflorasone diacetate demonstrated clinical efficacy in treating the signs and symptoms of psoriasis and eczema1-3 t Provides the benefits of an emollient-based formulation in a cream vehicle4-6 t Offers flexible QD–TID dosing options based on severity7 Instant Savings Card t Available for eligible patients Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Safety Information Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (please see adjacent page for full Prescribing Information). References: 1. Squires DJP, Masson EL. An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. J Int Med Res. 1981;9(1):79-81. 2. Lawless JF, Stubbs SS. Comparative efficacy of once-a-day diflorasone diacetate and T.I.D. hydrocortisone in treating eczematous dermatitis. Curr Ther Res. 1978;23(2):159-165. 3. Lebwohl MG, Medansky RS, Savin RC, Alton AV. Diflorasone diacetate cream in an optimized vehicle versus fluocinonide cream for the treatment of psoriasis. J Dermatol Treat. 1995;6:219-222. 4. Clark C. How to choose a suitable emollient. Pharm J. 2004;273:351-353. 5. Kraft JN, Lynde CW. Moisturizers: what they are and a practical approach to product selection. Skin Therapy Lett. 2005;10(5):1-8. 6. Factsheet: emollients. National Eczema Society Web site. http://www.eczema.org/Factsheet_Emollients.pdf. Accessed May 2, 2011. 7. ApexiCon® E Cream [Prescribing Information, 2008]. Melville, NY: PharmaDerm, a division of Nycomed US Inc. APEXICON is a registered trademark of PharmaDerm, a division of Nycomed US Inc. ©2011 PharmaDerm, a division of Nycomed US Inc. Melville, NY 11747. All rights reserved. 98NAPE030611 ,SLNHU[S`LMMLJ[P]L 52 Dermatology Times cosmetic dermatology Based on our experience, the ability to quantify cutaneous melanin levels eliminates the subjectivity inherent in the current means of skin assessment. ApexiCon E Cream (diflorasone diacetate cream USP 0.05%[emollient]) ® ApexiCon Cream ® (diflorasone diacetate cream USP 0.05% [emollient]) Rx only NOT FOR OPHTHALMIC USE DESCRIPTION: Each gram of ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) contains 0.5 mg diflorasone diacetate in a cream base for topical dermatological use. Chemically, diflorasone diacetate is: 6p,9-difluoro-11q,17,21-trihydroxy-16q-methylpregna-1,4diene-3,20-dione 17,21-diacetate. The structural formula is represented below: O CH2OCCH3 C=O H CH3 HO CH3 CH3 H H F O OCCH3 H O F H Each gram of ApexiCon E Cream (diflorasone diacetate cream USP 0.05% [emollient]) contains: 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified water. CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.) Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE: Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. CONTRAINDICATIONS: Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS: Pediatric Use). ® If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on an infant or child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free-cortisol test; ACTH stimulation test. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use: Safety and effectiveness of diflorasone diacetate emollient cream in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in pediatric patients. HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. ADVERSE REACTIONS: The following local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS). DOSAGE AND ADMINISTRATION: ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) should be applied to the affected areas as a thin film from one to three times daily depending on the severity or resistant nature of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated. HOW SUPPLIED: ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) is available in the following size tubes: NDC 0462-0395-30 NDC 0462-0395-60 30 gram tube 60 gram tube Store at controlled room temperature 20° - 25°C (68° -77°F) [see USP]. A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8395C/IF8395C #35 R1/08 | May 2012 Light on Lasers f rom page 51 (MOD). The higher the MOD, the lower the damage threshold of the epidermis. The calculated MOD minimizes the effect of tissue scatter and the competing chromophore hemoglobin. The MI measured by the Skintel device is directly proportional to the MOD and is expressed in values ranging from 0 (white) to 99 (black). The Skintel is handheld and is applied to clear facial skin, not directly over hair, lentigines or other pigment that could influence the reading. Each measurement is taken in less than a second, and after three measurements the device wirelessly transmits the average MI to the intense pulsed light (IPL) base station. The user can then utilize this information to help in selecting the optimal treatment setting. The authors’ practice consists of a diverse patient population, including many patients of Latin American and Caribbean descent. Unlike other devices we’ve tried, we found the Skintel quantification of melanin to be very consistent and usually within one to two units when measured on the same person in the same region several times. We also compared our pulsed light settings that were developed based upon years of experience without the use of Skintel to the recommended starting test spot fluence settings using Skintel readings. Recommended fluence settings were at or just below our experienced-based settings and helped streamline the number of test spots needed to identify optimal treatment settings. In some cases, particularly with mixed ethnicities, the MI readings gave us an excellent starting point for settings and increased our confidence in treating challenging patients with our IPL device. Due to its ease of use and reliability, the authors have also used the Skintel to assess patients’ MI prior to other treatments, including fractional, qualityswitched pigment and tattoo lasers, as well as longer-pulsed vascular and hair removal lasers. Based on our experience, the ability to quantify cutaneous melanin levels eliminates the subjectivity inherent in the current means of skin assessment, thereby providing an added level of patient safety for both beginning and advanced laser surgeons. DT Disclosures: Drs. Green and Kaufman have received research grants from Palomar Medical Technologies. May 2012 | DermatologyTimes.com cosmetic dermatology Colorful world Newer injectables, energies prove to suit darker skin types By John Jesitus Senior Staff Correspondent Washington — Just as they do in lighter- an ideal filler for that.” Belotero Balance also skinned patients, new injectable and allows very precise definition of the lip borders energy-based aesthetic treatments work and restoration of the white roll at the vermilion synergistically for patients of color, border, she says. “You can inject it all along the according to Hema Sundaram, M.D. In particular, combining newer neuromodulators and fillers with the latest radiofrequency (RF) and ultrasound-based treatments can provide results that are greater than the sum of their individual parts, says Dr. Sundaram, a Washington dermatologist and cosmetic surgeon in private practice. “The idea is to look at each patient individually. What Dr. Sundaram combination of procedures is going to give the patient what he or she is looking for — or hopefully results above and beyond what they’re looking for?” she says, adding that this requires an understanding of the patterns of aging, which are unique in skin of color, and how newer technologies can help address these changes. In the latter area, Dr. Sundaram says combining newer injectables and technologies allows multi-plane rejuvenation — targeting tissue levels from the epidermis to the subcutaneous and supraperiosteal tissue and the superficial muscular aponeurotic system (SMAS). “By combining treatments that address different tissue planes, we can get a very good synergistic effect,” she explains. Injecting synergy Among injectable fillers, “Belotero Balance (Merz/BioForm) is a different type of hyaluronic acid (HA) filler,” Dr. Sundaram says. Because it’s a cohesive polydensified matrix HA, “When you inject it, it distributes very smoothly and homogeneously through the skin, so there are no lumps or particles. That means you can inject it very superficially.” The product contains no particles to scatter back shortwave blue light, she adds, so injectors need not worry about the Tyndall effect. These characteristics make Belotero Balance especially well suited to fine lines, Dr. Sundaram says. “Although we as clinicians often think in terms of volumizing the face, patients are still very concerned about fine lines such as smokers’ lines in the perioral region. This is border, and superficially, and it will give a very nice restoration.” On a broader scale, she says this product fits Colorful world see page 54 53 54 Dermatology Times cosmetic dermatology | May 2012 Colorful World: Injectables, energ y-based devices rejuvenate darker skin from page 53 well within the multiplane rejuvenation technique. Dr. Sundaram uses high-viscosity, high G prime fillers such as Radiesse (calcium hydroxylapatite, Merz) or Perlane (HA, Medicis) for deep lifting volumization. “The high G prime confers a lot of lift; the high viscosity confers contour stability. I inject above the bones in the supraperiosteal plane, or subcutaneously,” she says. Dr. Sundaram then uses Belotero Balance superficially to get what she calls superficial tension volumization. “I run it through the dermis as a sheet. For all patients, including patients of color, injecting into the dermis creates a phenomenal restoration of radiance to the skin. It’s a very lustrous appearance, because you’re re-volumizing superficially,” she says. Additionally, physicians can use Belotero Balance for fine lines that remain after treatment with Botox (onabotulinumtoxinA, Allergan), Dysport (abobotulinumtoxinA, Medicis) or Xeomin (incobotulinumtoxin, Merz) in areas such as the forehead. “You can’t completely freeze the forehead or overinject neuromodulators there because that may look unnatural or drop the eyebrows,” she says. Presently, “I tend to work with lower doses of neuromodulators, in conjunction with fillers,” Dr. Sundaram says. “For instance, for the forehead or glabella, I might be using 20 to 22 units of Xeomin or Botox. The equivalent for Dysport would be about 50 to 55 units.” Among new neuromodulators, “Xeomin behaves exactly the same as Botox terms of dosing, effects, onset of effects and longevity. But it’s a purified toxin that doesn’t have accessory proteins,” as Botox does, she says. Xeomin’s lack of accessory proteins is considered an advantage in some respects, Dr. Sundaram says, because it may decrease the risk of resistance. “It makes for a very predictable neuromodulator,” she says. “We now have some evidence from basic science literature that the accessory proteins influence behavior of the toxin, even though they are supposed to dissociate from the toxin within a minute or two after injection (Cheng LW, Onisko B, Reader JR, et al. Toxicology. 2008;249(23):123-129. Epub 2008 May 2).” Conversely, she says Dysport has a broader field of effect, which physicians can leverage to patients’ advantage. In the lower face, for example, “Because of the beneficial spread, I can target a little bit of the depressor anguli oris along with the platysma to accomplish neck lifting and target a little bit of the masseter to achieve lower-face slimming. You can target multiple treatment areas from just a few injection points.” A split-face controlled study on which Dr. Sundaram served as a principal investigator in collaboration with San Diego dermatologist Mitchel Goldman, M.D., has shown that for crows’ feet in various skin types, Dysport via one injection site performs comparably to the same dose of Dysport delivered via three injection sites (American Society for Dermatologic Surgery Annual Meeting. Nov. 3-6, 2011. Washington). “You inject the same dose as you would with three injection points, but using one injection point may be beneficial because it reduces the risk of bruising and increases patient comfort,” she says. Getting energized As for energy-based treatments, Dr. Sundaram says that the Ulthera device May 2012 | cosmetic dermatology DermatologyTimes.com (Ulthera) delivers microfocused ultrasound energy at 3 mm, targeting the deep dermis, and at 4.5 mm, targeting the hypodermis, the SMAS and in the submental area, the platysma. In a recent study, “We looked at a very novel paradigm where we added additional targeting at 1.5 mm, which is superficial within the dermis,” she says. With this approach, patients had no post-treatment downtime, as the device spared the epidermis. “That’s important for patients of color — sparing the epidermis resu lt s i n a no -dow nt i me procedure and reduces or even eliminates the risk of postinflammatory hyperpigmentation,” she adds. “Nevertheless, using a validated scale, we saw significant improvement in pigmentation, particularly for the under-eye circles (Sundaram H, Onwudiwe O. American Society for Dermatologic Surgery Annual Meeting. Nov. 3-6, 2011. Washington).” I n a n o t h e r s t u d y, D r. Sundaram and her colleagues addressed pain control. In this double-blinded pilot study, researchers compared the impact of giving a single pretreatment dose of hydrocodone plus acetaminophen versus ibuprofen 800 mg one hour before treatment. “Then we did a full-face Ulthera treatment, upper and lower face, and asked patients to use a validated 10-point pain scale to assess their comfort level after treatment of each region,” she says. “You must use a validated scale to produce a high level of evidence.” Ibuprofen and the narcotic earned very comparable pain scores (Sundaram H. American Society for Dermatologic Surgery Annual Meeting. Nov. 3-6, 2011. Washington). Investigators found that for all areas treated at the 3 mm and 4.5 mm depths, “Pain scores came down to a very acceptable level of five or less, except for the 4.5 mm depth in the brow area,” where scores averaged six or seven, she says. Because studies of other types of skin treatment show that patients’ memories of the final treatment area can color their assessment of the entire experience, Dr. Sundaram suggests not treating the brow area last. The eTwo (Syneron) offers bipolar fractional radiofrequency (RF) energy for the dermis and epidermis. “Often, I will perform the dermal treatment first,” she says. Treating the dermis improves wrinkles and pigmentation and tightens the skin, she says. “Adding the epidermal bipolar fractional RF provides more improvement in pigmentation and improves fine lines, pores and even telangiectases.” The ePrime device (Syneron) uses 32-gauge microneedles to deliver bipolar RF energy into the reticular dermis. The treatment stimulates production of collagen, elastic tissue and HA, thereby providing volumization or remodeling of dermis, Dr. Sundaram says. She has used the procedure, sometimes with neuromodulators and fillers, in patients of color. The CO2RE laser (Syneron) provides RF-excited CO2 laser resurfacing. “The advantage of the RF-excited technology is that it enables you to turn the laser pulse on and off very precisely,” she says. The laser is tolerated by all skin types, even in a highly efficacious fusion mode combining deep and mediumdepth treatment. “With some of the older technologies, you can get this little ‘tail’ because there’s a little lag time in turning off the pulse,” she says. Because the tail delivers a low energy level, it does little therapeutically. “But it can generate enough heat in the skin to potentially cause postinflammatory hyperpigmentation.” DT Disclosures: Dr. Sundaram is a clinical investigator and consultant for Medicis, Mentor, Merz, Suneva, Syneron/Candela and Ulthera. 55 56 practice management Dermatology Times business consult 60 Elizabeth Woodcock is the principal of Woodcock & Associates and a speaker and writer specializing in practice management. Visit her Web site at www. elizabethwoodcock.com. | May 2012 Aim for accuracy E&M coding documentation critical for avoiding audits Service success Quality of care can make the difference between good and great encounters P hysicians with the most satisfied patients aren’t necessarily the ones who spend the most time with patients. Sometimes, even getting the highestquality goods or services doesn’t make up for a poor interaction. Think of staying at a luxurious hotel with a beautiful view but a surly staff. You might not rate that experience as highly as a stay at the friendly, wellkept bed-and-breakfast down the street. Are you creating satisfied patients? Assume that you’ve smoothed many of the bumps in your practice’s work flow processes so that patients are not waiting for significant periods of time, and let’s take it as a given that you and your practice are well regarded in the community. Superior customer service — the type that turns patients into advocates for your practice — hinges on more than just speed and quality, however. “There really is no preferred way of documentation. Any system is acceptable.” Quotable Allan S. Wirtzer, M.D. Sherman Oaks, Calif. On accurate E&M coding to avoid CMS audits See story, page 60 Creating delighted patients is a daunting proposition, considering the limited amount of time you spend with each patient. But it’s not impossible. Here are 10 strategies to make the most of each encounter. Introduce yourself. The patient, of course, knows who you are — they have an appointment scheduled with you — but this act of deference shows respect and always leaves the patient with a good impression. When appropriate, offer a handshake or a gentle touch during this introduction. Establish rapport. Treat each encounter as a building block in your relationship with the patient. Rapport doesn’t necessarily require an extensive conversation. It may just take one or two comments — an observation about a change in the weather, the big game last weekend, or perhaps an inquiry about how school is going for a child. By finding a bit of commonality with the patient, you establish a measure of camaraderie and trust. Listen. Of course, you listen to your patients, but physician, researcher and author Jerome → → → DT Extra Groopman observes that doctors typically interrupt their patients within 18 seconds of the start of a conversation. For many people, an interruption can feel like an insult. Try these techniques to refine your listening and communication techniques with patients: → Give the patient the opportunity to talk, then summarize their thoughts by saying: “Ms. Jones, I want to make sure that I understood you correctly. You said …(summarize complaint).” In two short sentences you are assuring patients they have been heard and you are establishing the agenda for the visit. By coming to agreement early on about the nature of the visit, you have the platform to politely defer any extraneous topics raised to a future visit. → Handle additional, unrelated issues like a pro. If the patient brings up additional complaints unrelated to the chief complaint, stress the need to give that new issue(s) proper consideration at another visit. For example, reply: “Mr. Jones, the issue you raise is so important that I’d like to allow business consult see page 59 Checklists set task accountability To ensure exam rooms are in order, determine the ideal state of every room and develop a checklist to use at the start of each day. Before clinic starts each morning, use the checklist to evaluate the readiness of each room. Assign responsibility for the task to one person — an assignment that may rotate — or each physician’s clinical support staff. Using a checklist to record what needs to be ready will mean you start off on the right foot, and allows you to establish accountability for tasks. Source: Elizabeth Woodcock, M.B.A., C.P.C., F.A.C.M.P.E. May 2012 | practice management DermatologyTimes.com business consult: Superior customer service creates satisfied patients from page 56 enough time to thoroughly discuss it with you. Let’s schedule a follow-up appointment about that.” • Use body language to your advantage. Lean in, not away, when talking or listening to patients. Make eye contact and avoid the football stance, which is sitting down with your knees apart. It gives the patient the impression that you’re about to leap out of your chair. Instead, sit down and cross your legs. Periodically, take your hands off the keyboard, or put your pen down. These actions show the patient that they are more than a record. Don’t look at your watch. Yes, you do have to keep track of time, but there are polite ways to do so. Hang a clock behind the head of the exam table at about eye level when seated. You can keep your focus on the patient with the clock also in your line of sight. To get help with the patients who really monopolize your time, ask your staff to page you (on vibrating mode) when you run more than, say, 30 minutes behind. One dermatologist told me he instructed his medical assistant to knock on the exam room door after a certain amount of time to say, “Dr. Gonzalez is on the phone for you.” Only he and his assistant knew that Dr. Gonzalez’ first name is “Speedy.” If you plan to deploy either of these “get a move on” techniques, be sure to also have a way to signal your staff that you really do need more time, such as telling them to “take a message.” Use your EHR: Part 1. Instead of poking your head out the door to summon a nurse or exploring the hallways to find a medical assistant, use the messaging capacities of your electronic health record system. Alternately, you can simply create your orders in the EHR with the expectation that your nurse or medical assistant will carry them out. Use your EHR: Part 2. Turn your EHR and its hardware into an exam-room located educational device. Position the computer monitor on a swivel base so you can share the information on the screen with the patient. Even better, install an LCD panel or flat screen on the wall of the exam room — 19-inch and 24-inch screens have become quite affordable. • • • It can give you a powerful way to show the patient who’s in for a skin check what suspicious moles look like, for example. If appropriate, you may even share the patient’s record with them on screen. The personalization possibilities an EHR offers will impress patients while educating them. Engage your patients. Waits and delays often are a result of paperwork. Establish a process by which your patients can complete medical history forms online or download them to complete before appointments. Your schedulers must be trained to encourage patients to visit your practice website. They also should collect an email address along with the other contact information so the patient can be sent a link to your website. In addition to helping patients fill out registration forms faster, a patient portal can allow you to channel appointment requests, medication renewals and other tasks that formerly required telephone calls to complete. If you don’t have access to an online portal for pre-registration, consider ways to make the on-site form completion go faster. Hand patients an iPad or tablet in the reception area on which to complete their forms, which can then be automatically fed into your EHR. Not only will it free your staff from rekeying information from written forms (and the ever-present risk of typos and errors), but front office employees will have more time to tend to patients. Your patients will appreciate a smoother, quicker process of completing registration, medical histories and other forms. • • Get the work pulled to you. The more time you spend between visits, the less time is left for each visit. When between patients, don’t wander around the office looking for messages, picking up test results, trying to locate staff and giving orders. Instead, create a workstation adjacent to the exam rooms you use most often. Teach staff to gather information and deliver it directly to your workstation. Set up your workstation with designated bins or areas specific to a purpose, such as a “red” bin for emergencies that you check between each patient. Designate another bin for standard messages from patients or referring physicians, and another bin to hold test results. Make sure your staff knows how to take complete and coherent messages from patients and referring physicians so that you — and they — do not waste time making callbacks for clarifying information. Physicians with the most satisfied patients aren’t necessarily the ones who spend the most time with patients. Sometimes, even getting the highest-quality goods or services doesn’t make up for a poor interaction. • Use videos. Computers and display panels in the exam room offer the opportunity for patients to watch educational videos. There are many commercially available products, but consider taping yourself explaining what to expect during a Mohs procedure, for example. If the patient watches it before or after your in-person explanation, so much the better. This reiteration of information via video helps patient compliance and allows you a few minutes to slip into the next room to see another patient who is in for a quick follow-up check. Some practices post their dermatologists’ videos on YouTube and encourage patients to watch them later, too. As payers put the squeeze on reimbursements, requiring you to work faster and see more patients, it seems that patients are getting more demanding of your time. While it is hard to find the happy medium, there is much you can do to ensure that patients get superior and respectful service at each visit. It’s the small things that transform service from good to great. DT 59 60 Dermatology Times practice management | May 2012 coding confidence Attention to documentation, decision-making requirements key to avoiding audits By John Jesitus Senior Staff Correspondent San Diego — Accurately coding for “If you undercode for fear of audits, you could penalize yourself in terms of reimbursement.” Allan S. Wirtzer, M.D. Sherman Oaks, Calif. E&M services account for the majority of services rendered by dermatologists for Medicare patients, Dr. Wirtzer says. However, if one codes too aggressively without appropriate supporting documentation, “You could potentially be targeted for audits,” he says. Conversely, “If you undercode for fear of audits, you could penalize yourself in terms of reimbursement,” he explains. “Your comfort level with coding has a profound effect on your ability to run your practice effectively.” One key to correct coding is the fact Abnormal, or not? Accurate E&M coding not only maximizes revenues — it can go a long way toward helping dermatologists avoid audits. that “it’s not about what you do or what you think you did — if it’s not documented, you didn’t do it,” Dr. Wirtzer says. Some physicians have developed impressive-looking documentation aids such as templates or diagrams, he says, “but not uncommonly, when I review charts, I’ll notice that these are not filled in adequately, and as a result, the aids go to waste.” By the same token, he says that in light of the push toward electronic health record (EHR) adoption, the Centers for Medicare and Medicaid Services (CMS) is taking a closer look at templates used for medical documentation. “It’s easy to use a macro or template,” Dr. Wirtzer says, “but if it is not in some way specific to the patient, it could be judged unacceptable.” In other words, CMS frowns upon what it calls production-line documentation systems, Dr. Wirtzer says. “Make sure your templates can be modified to take into account the situation at hand and how the patient is presenting to you. Sometimes in a record, I will see templates that contradict each other when you look at them carefully,” he explains. To further complicate matters, Dr. Wirtzer says that according to CMS, “There really is no preferred way of documentation. Any system is acceptable,” as long is it satisfies a handful of conditions that CMS has specified. However, “You can’t have a notation in the chart of something being abnormal without elaborating” on the abnormality, he says. For example, CMS will reject a notation that a patient’s lips are abnormal unless the EHR also indicates in what way they’re abnormal. “Furthermore, you can’t be too general with what you say is normal or abnormal,” Dr. Wirtzer says. “CMS has specifically said that they don’t particularly like the idea of documenting an entire organ system as being ‘negative.’” Dr. Wirtzer says some dermatologists may jot down a phrase such as “total body exam (sometimes abbreviated TBE) negative.” However, he explains, “According to CMS, that’s unacceptable.” Instead, CMS prefers that physicians spell out which portions of an organ system — or, in the case of dermatology, which areas of the skin — deviate from the norm, and how. Decisions, decisions The concept of medical decisionCoding confidence see page 60 Doctors: Getty Images/Siri Stafford/Digital Vision; Numbers: Getty Images/Digital Vision/Yagi Studio evaluation and management (E&M) services billed to Medicare requires mastering subtleties that aren’t always spelled out in coding instructions, said Allan S. Wirtzer, M.D., medical director, Mid Valley Dermatology and Cosmetic Surgery Center, Sherman Oaks, Calif., at the 2012 annual meeting of the American Academy of Dermatology. 62 Dermatology Times practice management | May 2012 coDinG conFiDence: Accuracy in documentation key to avoiding audits Another View making, a key component of E&M services, also can be unclear — especially if one relies solely on what the American Medical Association’s Current Procedural Terminology (CPT) manual says about this topic, Dr. Wirtzer says. To choose a level of medical decisionmaking for coding purposes, according to the manual, physicians must consider the following parameters: the number of possible diagnoses or treatment options; the amount and complexity of data required to make a decision; and the table of risk associated with the presenting problem, and with diagnostic options and tests used, as well as with the physician’s chosen method of managing the problem. More specifically, physicians must make a determination in each of these areas before choosing a level of medical decision-making for which to code, Dr. Wirtzer says, because these parameters drive one’s ultimate choice in E&M coding. Although this may sound complicated, Dr. Wirtzer says he has analyzed the CPT manual in this area and distilled it to a relatively simple rubric: “A single stable or improving condition is a straightforward level of medical Mark S. Nestor, M.D., Ph.D., voluntary associate professor, department of dermatology and cutaneous surgery, University of Miami Miller School of Medicine, spoke about contesting an audit at the 2011 annual meeting of the American Society of Dermatologic Surgery. Here’s some of what he had to say: “Fighting an audit is a huge burden, particularly for individual physicians … However, it is a battle worth fighting by those who know they are in the right.” “When we have gone through the process of appeal, we’ve won 99.4 percent of the claims appealed, and the few exceptions were not necessarily any different from the cases won.” Quick tip Some dermatologists tend to undercode for their services for fear of an audit. Dr. Wirtzer says understanding the documentation requirements for the CPT codes, and the modifiers used, will enable dermatologists to code confidently and withstand any critical review of their records. decision-making. If a patient has one worsening problem or two active problems, it’s equivalent to a low level of decision-making. And if a patient has a new, undiagnosed problem, the decision-making is moderate. “It’s critical that the physician or his or her staff carefully document the patient’s history, because the history portion of the documentation includes those details that will also determine the level of decision-making,” he adds. If documentation of the history reveals that a patient presented with both acne and a hand rash that have improved, “That’s two active problems, and it’s equivalent to a low level of decision-making,” Dr. Wirtzer says. “No matter how complex the process seems by going back to the CPT book, this is a simple way of determining medical decision-making.” Modifier 25 The -25 modifier, which provides separate identification for evaluations of unrelated problems handled during the same visit, also has prompted confusion among physicians, Dr. Wirtzer says. “This is important because CMS is sponsoring recovery audit contractor (RAC) audits,” he says. “Outside subcontractors are auditing records and requesting repayment of fees paid because CMS believes that money has been paid out inappropriately. The auditors are being very aggressive in their attempts to recoup money because they’re getting a portion of whatever they recover, like bounty hunters.” These audits focus specifically on the -25 modifier, Dr. Wirtzer says, which dermatologists can use when they perform an E&M service and a surgical service at the same visit. “The auditors are taking a very critical look at doctors’ records. If there isn’t what the auditors consider to be a very significant and separately identifi- from page 60 able service associated with the E&M code, they’re not going to allow payment for it,” he says. For example, if a patient hasn’t been seen for awhile and presents with lesions that are recognized as actinic keratoses (AKs), “CMS will not pay for a separate E&M service even though there is a legitimate argument that the doctor performed a separate cognitive service determining the need for a destructive procedure,” he says. Therefore, whenever physicians use the -25 modifier, “They must be very clear that the service performed is completely distinct from the surgery they’re performing,” Dr. Wirtzer says. For instance, he says that if a patient presents with numerous AKs — and the physician must distinguish them from many other benign lesions on the patient’s body such as moles or seborrheic keratoses — the doctor should clearly use the correct International Classification of Diseases (ICD)-9 codes to distinguish these other benign lesions from the AKs. In this case, “The destruction service will be correlated with the ICD-9 code for AKs, and the E&M service will be associated with the ICD-9 code for benign lesions,” he explains. “Dermatologists shouldn’t forget that sometimes, the time they spend explaining things to patients will be the basis for the E&M code they select,” Dr. Wirtzer adds. “E&M services in which counseling and/or coordination of care (account for) more than half of the faceto-face time of the visit may be coded based on time alone. “If a patient comes back with an acne condition that’s not improving, the CPT code selected based upon the key components of the examination may indicate a Level III service,” he says. However, if during a 25-minute visit the physician spends a significant amount of time — which CMS defines as greater than half the encounter time — talking about Accutane (isotretinoin, formerly manufactured by Roche) and its benefits and risks, “This would be a Level IV service based on the amount of time the physician spent with the patient and/or the patient’s family,” he says. DT Disclosures: Dr. Wirtzer reports no relevant financial interests, other than in the success of his practice, he says. Raising the Bar for Skin Health. New Protocols and Solutions for Creating Healthy Skin. ZO® Therapeutic Solutions ZO Skin Health Circle ® ™ Comprehensive & Continuous Solutions ZO® Daily & Preventive Skincare Dr. Zein Obagi, Medical Director ZO® World Premiere Under the guidance of Dr. Zein Obagi, ZO Skin Health, Inc. has developed a wide spectrum of new therapeutic treatments and daily skincare solutions that create and maintain healthy skin. 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Both Cetaphil DermaControl products are gentle, noncomedogenic and have been clinically tested with common acne medications for tolerability and performance. For more information: www.cetaphil.com The newly launched Intense Skin Rehab System is a targeted hydration and barrier repair kit. The system was designed to be a takehome regimen following moderate to deeper skin rejuvenation procedures. Comprised of the Epionce enriched firming mask and the Epionce medical barrier cream, the two products provide a boost of hydration while rapidly restoring healthy barrier function. They help soothe and calm highly sensitized skin. Patients using the Intense Skin Rehab System following ablative laser procedures recovered five to six days faster than normal postprocedure downtime, the company says. The enriched firming mask rapidly relieves redness, provides additional hydration and helps increase elasticity and firmness in the skin. For more information: www.epionce.com GlyTone Peel system targets aging Glytone introduces its Glytone by Enerpeel PA peel system (pyruvic acid, 50 percent), which includes 15 peel systems, for signs of premature aging and acne. These advanced single-dose exfoliation peels use a carrier technology for optimal results. The peel system delivers better chemoexfoliation with less surface trauma to minimize fine lines and wrinkles, reduce acne and provide an immediate glow, according to the company. Its indications are for seborrhea and comedogenic acne occurring with seborrhea; actinic keratosis of moderate severity; fine lines, wrinkles and signs of chrono- and photoaging; and skin damage due to environmental factors and/or oxidative stress. For more information: www.glytone-usa.com To have information about your company’s product or service considered for this section, send news releases and photos to: New Products and Services Dermatology Times 24950 Country Club Blvd. Suite 200 North Olmsted, OH 44070 or fax to (800) 788-7188 Publication is subject to space availability and appropriateness, at the editors’ discretion. Topix pharmaceuTicals Moisturizing lotion is fortified Replenix Green Tea antioxidant moisturizing lotion is a silky, fast-absorbing moisturizer that helps restore and maintain a healthy skin barrier function while preventing transepidermal water loss. The lotion delivers a blend of nourishing and protective antioxidants and emollients to help soften dry skin, according to the company. The lotion is nontoxic, noncomedogenic, nonirritating and is free of preservatives, oil, alcohol and fragrances. The lotion uses such ingredients as green tea polyphenols, caffeine, resveratrol, hyaluronic acid, ceramide 2, bisabolol and natural sterols. It contains selected penetrating lipids, which repair the natural moisture barrier to provide healing benefits to the skin. The lotion is ideal for daily use, the company states. For more information: 800-445-2595 www.topixpharm.com nail creaTions Nail prototype covers toenail loss A Cleveland barber has a solution to help disguise women’s toenail loss — a nail prototype designed to cover exposed toes. Maria Barile engineered Nail Creations, a latex-free adhesive wrap available online, through physicians’ offices and at several shops. The product includes 16 adhesive nails in assorted sizes. The product is designed to allow wearers to put on the wrap, add nail polish, and then remove the product when desired. The “nail” can be worn for up to two days. Nail Creations is not a medical device, but a temporary, cosmetic adhesive cover. Companies interested in selling the product wholesale can contact NailCreations at its website. For more information: www.appealingwhilehealing.com www.facebook.com/NailCreations1 polloGen Skin system contours body The apollo system is an aesthetic solution based on TriPollar radiofrequency technology. It helps to safely and effectively contour the face and body, according to the company. The treatment is noninvasive, painless, and is effective on all skin types. The focused energy eliminates the need for a cooling mechanism, the company states. The office-based treatment offers immediate visible results. The system addresses localized fat reduction, circumference reduction, facial contouring, fine lines and wrinkle reduction, skin tightening, improved décolletage and stretch marks. For more information: 877-701-2699 www.pollogen.com molesafe Melanoma screening diagnoses early MoleSafe, an advanced melanoma screening program, helps diagnose melanoma at the earliest possible stage and provides a complete digital record of the skin down to the microscopic level. The digital record of the patient’s skin becomes the baseline by which changes to moles may be identified on follow-ups. Utilizing skin surface epiluminescence microscopy (dermoscopy), lesions are digitally imaged, archived and linked to the relevant body location. The patient’s history of skin cancer, sun exposure and other relevant clinical data are recorded. All images and associated data are encrypted and sent via a secure network to be diagnosed and reported on by one of the panel of experts. For more information: www.molesafe.com Your patients deserve a stretch marks therapy that lives up to its promises. Wear your skin proudly.™ Mederma® Stretch Marks Therapy is specifically formulated and clinically shown to reduce discoloration and improve the appearance of stretch marks.1 • 76% of women who used Mederma® Stretch Marks ACTUAL RESULTS Therapy for 12 weeks were satisfied with their results.2 • 80% of women in a clinical study showed visible improvement in 12 weeks.1 ® Before More information at mederma.com. ©/ /™ 2012 Merz Pharmaceuticals, LLC 1 SKINmed: Dermatology for the Clinician, April 2010. 22011 Survey conducted by Merz Pharmaceuticals, LLC After 12 weeks 66 Dermatology Times calendar Product American Dermoscopy upcoming events American Safety Razor - Personna Dermatology Times lists meeting announcements for the following three months in our print issue. For a full listing of events, go to www.dermatologytimes.com www.mohscollege.org May 3-6, 2012 Fairmont Hotel Chicago May 2012 ad index Advertiser American College of Mohs Surgery 44th Mohs College Annual Meeting | Dannemiller and American Dermoscopy Meeting www.americandermoscopy.com June 22-23, 2012 Four Seasons Resort Jackson Hole, Wyo. Page 55 DermaBlade 045 Aqua Pharmaceuticals Monodox 7 Bayer Dermatology Corporate 5 Eucerin 33 Beiersdorf Ceptaris Therapeutics Inc 15 Connectivision 35 Coria Labs Retin-A CV2-3 Dusa Pharmaceuticals Inc Levulan 12-13 Galderma Laboratories Inc Cetaphil CV3 International Dermoscopy Society 3rd World Congress of Dermoscopy International Federation of Psoriasis Assocations 3rd World Psoriasis & Psoriatic Arthritis Conference www.dermoscopycongress2012.org May 17-19, 2012 Brisbane Convention & Exhibition Center Brisbane, Australia http://ifpaworldconference.com June 27-July1, 2012 Stockholm Waterfront Congress Centre Stockholm, Sweden Galderma Laboratories Inc Differin 57-58 Galderma Laboratories Inc Epiduo 47-48 Australasian College of Dermatologists 45th Annual Scientific Meeting Society of Dermatology Physician Assistants Summer Dermatology Conference Galderma Laboratories Inc Oracea 37-38 Genentech Inc Erivedge 21-22 www.dermcoll.asn.au May 20-23, 2012 Brisbane Convention & Exhibition Center Brisbane, Australia www.dermpa.org July 11-15, 2012 The Westin Seattle Seattle American Society for Mohs Surgery Dermatologic Surgery: Focus on Skin Cancer Society for Pediatric Dermatology 38th Annual Meeting www.mohssurgery.org May 24-27, 2012 Sheraton Wild Horse Pass Resort & Spa Chandler, Ariz. Georgia Society of Dermatology & Dermatologic Surgery 57th Annual Meeting www.gaderm.org June 1-3, 2012 Westin Hilton Head Island Resort & Spa Hilton Head Island, S.C. Chinese Society of Dermatology 3rd World Congress on Genodermatology www.cmacsd.org/wcg2012/ June 12-14, 2012 China National Convention Center Beijing Alabama Dermatology Society Summer Symposium www.alabamaderm.org June 21-24, 2012 Sandestin Hilton Hotel Sandestin, Fla. La Roche Posay 25 Medical Technology 43 Merz Pharmaceuticals Mederma 65 www.pedsderm.net July 12-15, 2012 Portola Hotel & Spa at Monterey Bay Monterey, Calif. Merz Pharmaceuticals Naftin 27-28 North Carolina Dermatology Association 2012 Annual Meeting Palomar Medical Technologies Pacific Bioscience Laboratories 09 Icon CV4 Pharmaderm Apexicon E Cream 51-52 Pharmaderm Veregen 41-42 8th Annual Cosmetic Bootcamp Promius Pharmaceuticals Promiseb Cover Tip www.cosmeticbootcamp.com July 19-22, 2012 Broadmoor Resort Colorado Springs, Colo. Ranbaxy Pharmaceuticals Inc Halog 11 Ranbaxy Pharmaceuticals Inc Kenalog 31 National Medical Association 2012 Annual Convention & Scientific Assembly Revision Skincare Teamine 61 Spear Dermatology Refissa 53-54 Valeant Dermatology Acanya 17-18 www.ncmedsoc.org July 13-15, 2012 The Homestead Hot Springs, Va. www.nmanet.org July 28-Aug. 1, 2012 New Orleans Convention Center New Orleans, La. ZO Skin Health 63 This index is provided as an additional service. The publisher does not assume any liability for errors or omissions. May 2012 | 67 DermatologyTimes.com Go to: products.modernmedicine.com Products & Services ShowcaSe cosmeceuticals AZACleAr COMING SOON - AzA Skin Whitening System • Diminishes the appearance of fine lines & wrinkles • Visibly reduces breakouts • Targets dark spots; improves skin texture & tone Search for the company name you see in each of the ads in this section for FREE INFORMATION! Search 68 Dermatology Times | Products & Services ShowcaSe Go to: May 2012 products.modernmedicine.com education ASMS Search American Society for Mohs Surgery Upcoming CME Activities Annual Clinical Symposium – Dermatologic Surgery: Focus on Skin Cancer Closures Course and Fundamentals of Mohs Surgery November 5 - 7, 2012 – Closures Course for Dermatologists Course prerequisite is basic experience in cutting and sewing skin, and program is designed to take dermatologists to the next level of dermatologic surgery practice. This is an intense 2-day experience in closure considerations for the surgeon with a primary interest in closing surgical defects. It will feature practical techniques, site specific discussions, and numerous reconstruction “pearls,” based upon presenters’ extensive derm surgery experience. Memorial Day Weekend, May 24 - 27, 2012 Sheraton Wild Horse Pass Resort & Spa – Chandler, Arizona Top experts in the field will provide updates on a wide range of dermatologic surgery and Mohs surgery topics. Separate interactive panels will discuss appropriate repair strategies for a variety of surgical wounds and innovative approaches to melanoma treatment. Both Mohs and non-Mohs cases will be featured in the microscope laboratory. Mohs nursing staff, technicians and other Mohs support personnel will increase their knowledge of skin cancer treatment and develop a greater appreciation for their unique roles in supporting high quality dermatologic care. AMA PRA Category 1 Credit Available For additional information regarding ASMS educational activities, membership opportunities, and patient resources, please contact: Novella Rodgers, Executive Director American Society for Mohs Surgery 5901 Warner Avenue, Box 391 Huntington Beach, CA 92649-4659 Tel: 800-616-2767 or 714-379-6262 Fax: 714-379-6272 www.mohssurgery.org [email protected] November 8 - 11, 2012 – Fundamentals of Mohs Surgery for Dermatologists and Mohs Technicians Developed as a comprehensive introduction to Mohs surgery, the course provides an overview of Mohs indications, mapping techniques, office set-up and instrumentation, and interpretation of Mohs histopathology. Instruction in key concepts is facilitated by lectures, “pearls” discussions, interactive Q&A sessions, video microscope demonstrations, and challenging microscope electives. The Mohs technician program will feature hands-on training in Mohs laboratory techniques and incorporate important safety and regulatory guidelines and updates. A high faculty-to-student ratio helps ensure rapid skill development and advancement, and allows for discussion of critical troubleshooting techniques relative to tissue processing and slide preparation. AMA PRA Category 1 Credit Available education ASDS Tired of getting lost in the crowd? Search When you join the ASDS family, you’re face-to-face with the best and brightest experts in the field. 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Search May 2012 | 71 DermatologyTimes.com Go to: products.modernmedicine.com Products & Services ShowcaSe services Search for the company name you see in each of the ads in this section for FREE INFORMATION! 72 Marketplace Dermatology Times | May 2012 products & services office space available practice for sale OFFICE FOR SUBLEASE/SHARE NYC Upper East Side Medical Office AAASC Certified Includes 2 Exam Rooms, Reception & Operatory Perfect for a Dermatologist For more information contact: [email protected] practice for sale national PRACTICE SALES & APPRAISAL oregon Suburban North Atlanta. Practice for Sale Fee for Service Dermatology Practice for Sale. Branded Name. Affluent equestrian, lake, and golf community. Top public and private schools. 4500 active charts, 2500 monthly newsletter participants, high organic internet search placement. Highly experienced sales and medical staff are eager to assist in transition. Equal balance of medical and cosmetic services offered. Equipment included in the sale: all office furnishings in the 3000 square foot office, 5 equipped examination rooms/surgical suites, sterilization area, 1 Fraxel SR 1500 laser, 3 Thermage Radiofrequency Devices, 1 Liposonix HIFU system, 1 Zimmer Cooler system, 1 Silk Peel Microinfusion system, 5 Station Computer System with 7 Provider Office Hours Software, branded lobby loop plasma TV advertising program, passive retail product sales area generating $5000-8000/month, branded website coded for new provider. $700,000. For more information, please contact Mr. Ross at [email protected] Expert Services for: Buying or Selling a Practice Practice Appraisal Practice Financing Partner Buy-in or Buy-out 64 YO Mohs surgeon / dermatologist contemplating retirement in 6-18 months. Looking for someone who enjoys a combination of Mohs, reconstruction, lasers, cosmetic and general derm. I have a productive PA and a loyal staff. It would be great if that staff still had a place to work after I retire. We are a few minutes from Portland, Oregon, land of biking, hiking, beautiful scenery and a relaxed lifestyle. Principals only. Please respond to [email protected] www.GoodSkinMD.com Peter Goodkin kentucky PRACTICE FOR SALE OR LEASE E L I Z ABE T H T O W N , K E N T U C K Y 36 YEAR ESTABLISHED FUNCTIONING PRACTICE Critical need for a Dermatologist in growing area near Ft. Knox. Tremendous potential. Office is a 2-story converted home on 2/3 acres of commercial land on main traffic route, across from Hospital with a Human Resource center located 10 miles from office containing a large Federally Employed population. Turn-key operation with experienced staff. Located 40 miles south of Louisville, Kentucky on I-65. Call or email to discuss generous terms. Call for a Free Consultation (800) 416-2055 www.TransitionConsultants.com We Buy Practices • • • • • georgia Call Karen Gerome to place your Products & Services FREE SPACE ad at 1 col x 2 800.225.4569 ext. 2670 [email protected] Available at (877) 769-6327 [email protected] or (423) 821-8230 jmgalex@epbfi.com Retiring Monetization of your practice Locking in your value now Succession planning Sell all or part of your practice products Please call Jeff Queen toll free at (866) 488-4100 or email [email protected] www.MyDermGroup.com Marketplace Can Work For You! ★ ★ Reach highly-targeted, market-specific business professionals, industry experts and prospects by placing your ad here! ★ ★ ★ Together, we can save a life 1-800-GIVELIFE www.redcross.org American Red Cross May 2012 | Marketplace DermatologyTimes.com recruitMent california florida pennsylvania BC/BE Dermatologist and/or Mohs Surgeon Needed in Las Vegas We seek a dynamic Northeast PeNNsyLvaNia Very Competitive salary & benefits. Excellent opportunity. Please send CV to: [email protected] florida Southeast Coast • Lucrative, well-established basic and skin cancer oriented practice seeks FT • BC/BE, MD/DO - Associate Needed “ Beautiful Year round Climate and Beaches” Call 561-498-2028 SARASOTA BAYFRONT • Growing Dermatology Practice • Ready for Associate • Medical/Surgical/Cosmetic “Practice like you dreamed about” Fax (941)951-1966 DERMATOLOGIST OPPORTUNITY IN FLORIDA (between Tampa and Orlando) Financially stable multi-specialty group seeks a BE/BC Dermatologist to join our existing collegial group of 6 Dermatologists, 2 Dermatopathologists and Mohs surgeon. Option to read your own slides. •ExtensiveservicesIn-house(lab,radiology includingMRIandCT,phototherapywith UVB&PUVA) •MedicalSpa •200+physician-ownedandrunpractice; 40specialties •Verycompetitive1styrsalaryguarantee+ bonus;Partnershipafter2yrs •Extensivebenefitswithprofessionalliability insurance&relocationassistance •Exceptionalsuburbansettingwithexcellent reimbursement •Abundantrecreationyearround–500+lakes andnumerousparks;within45minutesof Orlando&Tampaattractions •NO STATE INCOME TAX! WATSON CLINIC LLP 1600 Lakeland Hills Blvd. Lakeland, FL 33805 800-854-7786 • Fax 863-680-7951 email: [email protected] BC/BE Mohs Surgeon and General Dermatologist to join our progressive, young practice. This is a full time opportunity with the potential to earn an equity interest in the practice in Southwest Florida. Our dermatology practice provides general & cosmetic dermatology, Mohs surgery, in house pathology, and much more. In addition, we provide insurance benefits, malpractice coverage and great compensation package. Busy dermatology practice seeks BE/BC dermatologist for our 32 year old, four physician, four physician assistant practice. General dermatology and subspecialty interest welcomed. Excellent compensation, benefits and partnership opportunity. www.lackawannadermatology.com. Please contact Kathryn Colombo, Practice Manager at [email protected] or by fax 570-207-5579 Email: [email protected] BC/BE Dermatologist PENNSYLVANIA illinois Well-established, thriving practice with 7 dermatologists seeks BC/BE Dermatologist. State of the art 12,000 sq. ft. new facility with in-house Mohs, dermatopathology, aesthetic services, lasers and phototherapy. Excellent benefits, malpractice, health insurance, vacation/ CME. Partner buy-in after 2 years. Located in a rapidly-growing, affluent, family-oriented community with a population of 519K. Dermatologist BC/Bs ottawa, illinois Busy Practice - 1 Hour from Chicago Please Call Lori 708-460-7890 Fax Resume 708-460-5537 Email: [email protected] Call Bonnie Oberholtzer at (717) 509-5968 or e-mail to: [email protected] new jersey Dermatologist tennessee General/Cosmetic/Surgical Dermatology Medford, NJ (near Philadelphia, PA and Cherry Hill, NJ). Brand new state of the art office, fabulous opportunity, benefits offered. FT/PT position available. email inquiry or CV to: [email protected] new york E B C/ B Scenic S.E. city on the TN River offers wonderful recreation and cultural activities 4 busy midlevel providers, Mohs, Histolab Full partnership and earnings of 1.5 mil after P/T Dermatopathologist for practice in Nassau County, N. Y. Please fax CV to: 516-482-6039 or email: [email protected] 3 years. No out of pocket buy in Email - [email protected] Fax - 423-899-2703 virginia RICHMOND, VA Call Jacqueline Moran to place your Recruitment ad at 800.225.4569, ext. 2762 [email protected] Opportunity available in historic Richmond, VA. Well-established practice seeking BC/BE General/Surgical/ Cosmetic dermatologist. State-of-the-art facility. Excellent benefits, malpractice, health insurance. Email CV to [email protected] 73 74 Dermatology Times | May 2012 physician’s profile John E. Olerud, M.D. Born: Fargo, N.D., 1943 Medical degree: University of Washington, Seattle Internship: University of Washington Residencies, internal medicine and dermatology: University of Washington Hobbies: Baseball, golf, photography Family: Wife, Lynda Olerud; son, John G. Olerud; daughter, Erica Olerud; and three grandchildren John E. Olerud, M.D., holding his son in Albuquerque, New Mexico, after a game in 1970. (Photo: John E. Olerud, M.D.) Up to bat From baseball to dermatology, physician stays on top of his game with talent, passion In His Own Words: What is the best professional advice you ever received? While playing for WSU under coach Chuck “Bobo” Brayton, Dr. Olerud says he learned these important lessons about life: Take pride in your organization, pride in your country and pride in the work you do. Don’t let anyone outwork you. Don’t let anyone be better prepared than you are. A swinging bat is a dangerous bat. If you’re not swinging a bat, you’re not going to get any hits. Over a long period of time, excellence and quality are the most important things to come out of an organization. By lisette Hilton Staff Correspondent A ccording to dermatologist John E. Olerud, M.D., “Life is a lot like baseball.” In fact, Dr. Olerud often shares with his trainees the life lessons he learned as a professional baseball player. He focused on the topic in a recent acceptance speech, when Washington State University honored him last year with its Regents’ Distinguished Alumnus Award. And the dermatologist’s beloved sport remains a part of his daily teaching. “My poor residents have to listen to all the metaphors about baseball,” he says. Baseball is a topic near and dear to Dr. Olerud. While earning his undergraduate degree at Washington State University during the mid1960s, he was team captain and catcher for the WSU Cougars. The team went to the College World Series, and Dr. Olerud was named to the All-American Team. He continued a career in baseball while attending medical school at University of Washington, Seattle, playing professional ball every summer. After six years of medical school and seven summers playing in the minor leagues for such clubs as the Seattle Angels, San Jose Bees, El Paso Sun Kings, Tulsa Oilers and Win- nipeg Whips, Dr. Olerud pursued a career in dermatology. “Baseball was my first passion and medicine was what I knew I’d do in the long term,” he says. “If I had been as good a ballplayer as my son, I probably would have played as long as I could.” After Dr. Olerud’s successful run in the sport, he lived vicariously through his son, John G. Olerud, who made his mark as a major league first baseman. From 1989 to 2005, John Olerud played professionally for the Toronto Blue Jays, New York Mets, Seattle Mariners, New York Yankees and Boston Red Sox. A three-time Gold Glove winner, John Olerud won the American League batting title in 1993, and he was runnerup for the National League batting title in 1998. From sports to medicine Dr. Olerud’s claim to fame in dermatology is a focus on teaching and research. Head of the dermatology program at the University of Washington, he says he is proud of the school’s dermatology training program. His research, especially in wound healing, has resulted in more than 90 publications and several government and other grants. His main area of research is diabetic wound healing and developing models to study wound healing. His clinical research and publications have been in T-cell lymphoma. Still time for baseball Dr. Olerud never lost his competitive nature on the field. He catches for a team in the Seattle area, which year after year wins the Roy Hobbs adult amateur World Series in Florida. “We have quite a bunch of ball players up here that won’t give it up,” he says. “I was a catcher then and am still a catcher.” While his goal on the field might be to keep winning the World Series, Dr. Olerud, who is a past-president of the Association of Professors of Dermatology, says his approach in dermatology can be summarized in the movie line, “If you build it, they (residents) will come.” “We’ve been trying to create an environment at University of Washington where young people can succeed and become leaders in clinical and academic dermatology,” he says. “I’m hoping that when I hand the division off to the next generation, it’s in better shape than it was when I received it. And I hope this will continue to be thought of as an outstanding dermatology program.” DT Now achieve harmony in acne management Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 for patients with acne-prone skin CONTROL oil with a highly tolerable regimen formulated with advanced zinc technology1-4 PROTECT with an SPF 30 moisturizer and restore barrier function with ceramide technology5 BALANCE control of both acne symptoms and acne treatment effects1* *Formulated to be used with acne treatments. References: 1. Data on file. Galderma Laboratories. 2. Bigotti C, Guala F, Merlo E, Gazzaniga G, Villa G. Zinc and its derivatives: their applications in cosmetic. J Appl Cosmetol. 2005;23:139-147. 3. Rigano L, Merlo E, Guala F, Villa G. Stabilized solutions of zinc coceth sulfate for skin cleansing and skin care. Cosmetics Toiletries. 2005;120:103-108. 4. Schwartz JR, Marsh RG, Draelos ZD. Zinc and skin health: overview of physiology and pharmacology. Dermatol Surg. 2005;31:837-847. 5. Castiel-Higounenc I, Chopart M, Ferraris C. Stratum corneum lipids: specificity, role, deficiencies and modulation. OCL. 2004;11(6):401-406. cetaphil.com © 2012 Galderma Laboratories, L.P. Galderma is a registered trademark. Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CETA-393R Printed in USA 02/12 CONFIDENCE IS EMPOWERING. CONFIDENCE TRANSLATES INTO RESULTS. INTRODUCING THE PALOMAR ICON ™ LASER AND OPTIMIZED LIGHT ™ AESTHETIC PLATFORM FEATURING TURBOCHARGED COOLING AND SMOOTH PULSE SM TECHNOLOGY. WITH TREATMENTS SO COMFORTABLE, IT TAKES COSMETIC PROCEDURES TO NEW HEIGHTS. OWN THE NEW SYMBOL OF INNOVATION, AND FEEL THE CONFIDENCE. TM WWW.PALOMARMEDICAL.COM/ICON © 2012 Palomar Medical Technologies, Inc. Palomar is a registered trademark, Palomar Icon, and Optimized Light are trademarks and SmoothPulse is a service mark of Palomar Medical Technologies, Inc. ALL RIGHTS RESERVED. 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