Wearable technology meets dermatology
Transcription
Wearable technology meets dermatology
Dermatology Times® Clinical Analysis for Today’s Skincare Specialists February 2015 Wearable technology meets dermatology Volume 36 No. 02 Integrating devices with skin may one day help to monitor, diagnose disease February 2015 | VOL. 36, NO. 02 | Clinical The 8-year-old patient shown above displays psoriasis plaques. Photo: Paradi Mirmirani, M.D. Clinical Analysis for Today’s Skincare Specialists Obese children present with more inflammatory conditions Louise Gagnon | Staff Correspondent Esteya® Obesity is certainly not a public health issue confined to adults, and the rise in obesity in children has shown an impact on dermatological conditions, according to Paradi Mirmirani, M.D., assistant clinical professor in the department of dermatology at the University of California at San Francisco, San Francisco. She is a general dermatologist at Kaiser Permanente Northern California Managed Healthcare System in Vallejo, Calif. “The (excess) adipose tissue is having a large effect on the skin (in children),” Dr. Revolutionizing skin cancer treatment CHILDHOOD OBESITY see page 21 A In This Issue SHOWN HERE are two examples of epidermal electronics. A. A test platform for basic electronic building blocks and skin sensors. B. A fully wireless, radio-enabled system that measures temperature, motion and ECG. Photos: John Rogers, Ph.D. February 2015 VOL. 36, NO. 02 CLINICAL 14 Skin presentations in obese patients Chronic conditions worsen; bariatric skin heals poorly; dermatologists should counsel patients B DermatologyTimes.com COSMETIC 22 Aesthetics and social media in 2015 Are social media platforms really influencing patients’ aesthetic decisions? Lisette Hilton | Senior Staff Correspondent Imagine wearing electronics powerful enough to transdermally measure things like hydration, electrophysiological activity and pulse and cerebral oximetry. But the technology is so thin, breathable, soft and malleable, that you don’t notice it on your skin. It can be on your eyelid, on your lips, over hair. It seamlessly does its job while you live your life without constraint. John A. Rogers, Ph.D., professor of material science and engineering at University of Illinois, and his colleagues are developing this wearable technology and big pharma, dermatology faculty and the beauty industry, including L’Oreal, are studying the technology’s applications and using it to do research “The goal is really to render electronics, radios, advanced sensors in forms that look and feel like the skin, itself. That’s to enable a kind of intimate level of contact and in- ONCOLOGY 32 Cutaneous T-cell lymphoma Targeted therapies may lead to better-understood combinations, higher response rates, better survival Electronic Brachytherapy for Treating Skin Cancer BUSINESS 42 Revving revenues Clinical trials, dispensing skincare products represent opportunities in an ever-changing landscape WEARABLE TECHNOLOGY see page 18 VISIT ESTEYA.COM | THE TAKEAWAY | PETER LIO, M.D., discusses considering treatment plans using alternative medicine. SEE PAGE 57 888.00670 MKT [00] Availability of Esteya® in target markets is dependent on regulatory admissions and approvals. Please contact your Elekta representative for details. Dermatology Times® Clinical Analysis for Today’s Skincare Specialists February 2015 | VOL. 36, NO. 02 | February 2015 Wearable technology meets dermatology Volume 36 No. 02 Integrating devices with skin may one day help to monitor, diagnose disease Clinical The 8-year-old patient shown above displays psoriasis plaques. Photo: Paradi Mirmirani, M.D. Obese children present with more infammatory conditions Clinical Analysis for Today’s Skincare Specialists Louise Gagnon | Staff Correspondent Obesity is certainly not a public health issue confined to adults, and the rise in obesity in children has shown an impact on dermatological conditions, according to Paradi Mirmirani, M.D., assistant clinical professor in the department of dermatology at the University of California at San Francisco, San Francisco. She is a general dermatologist at Kaiser Permanente Northern California Managed Healthcare System in Vallejo, Calif. “The (excess) adipose tissue is having a large effect on the skin (in children),” Dr. CHILDHOOD OBESITY see page 21 A In This Issue SHOWN HERE are two examples of epidermal electronics. A. A test platform for basic electronic building blocks and skin sensors. B. A fully wireless, radio-enabled system that measures temperature, motion and ECG. Photos: John Rogers, Ph.D. February 2015 VOL. 36, NO. 02 CLINICAL 14 Skin presentations in obese patients Chronic conditions worsen; bariatric skin heals poorly; dermatologists should counsel patients B DermatologyTimes.com COSMETIC 22 Aesthetics and social media in 2015 Are social media platforms really infuencing patients’ aesthetic decisions? Lisette Hilton | Senior Staff Correspondent Imagine wearing electronics powerful enough to transdermally measure things like hydration, electrophysiological activity and pulse and cerebral oximetry. But the technology is so thin, breathable, soft and malleable, that you don’t notice it on your skin. It can be on your eyelid, on your lips, over hair. It seamlessly does its job while you live your life without constraint. John A. Rogers, Ph.D., professor of material science and engineering at University of Illinois, and his colleagues are developing this wearable technology and big pharma, dermatology faculty and the beauty industry, including L’Oreal, are studying the technology’s applications and using it to do research “The goal is really to render electronics, radios, advanced sensors in forms that look and feel like the skin, itself. That’s to enable a kind of intimate level of contact and in- ONCOLOGY 32 Cutaneous T-cell lymphoma Targeted therapies may lead to better-understood combinations, higher response rates, better survival BUSINESS 42 Revving revenues Clinical trials, dispensing skincare products represent opportunities in an ever-changing landscape WEARABLE TECHNOLOGY see page 18 | THE TAKEAWAY | PETER LIO, M.D., discusses considering treatment plans using alternative medicine. SEE PAGE 57 magenta cyan yellow black ES557281_DT0215_CV1.pgs 01.22.2015 02:26 ADV magenta cyan yellow black ES555404_DT0215_CV2_FP.pgs 01.17.2015 01:25 ADV INTER FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Resource Center s Best practices in the evaluation and management of actinic keratoses What’s your diagnosis? A 3-year-old girl was brought in with these spots on her feet, and her mom says she has sores in her mouth as well. CHOOSE ONE: HERPES SIMPLEX KAWASAKI DISEASE COXSACKIEVIRUS bit.ly/februarydiagnosis LAST MONTH’S DIAGNOSIS: Erosive Pustular Dermatitis Will a hot tub soak prior to CoolSculpting improve results? 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For more information on specialized areas of dermatology, related articles and business resources, go to: modernmedicine.com/ResourceCenters CTIVE Follow us on Twitter to receive the latest news and participate in the discussion @EMJDermatology @LizGoodale Neutrophilic Dermatoses Revisited. #Dermatology ow.ly/Hc07B How #cognitive computing and #analytics could improve #skin #cancer image analysis bit.ly/14dEmOU @ IBMWatson #Oncology #dermatology @DermpathUAMS Monotonous round pericytic cells surround dilated vascular channels in glomangioma #pathologists #dermatology Telemedicine Market to Grow at a CAGR of 14.3 Between 2014 and 2020 Transparency Market Research ow.ly/2Tk7Yt twitter.com/DermTimesNow @Dermatology_bio #Dermatology News: Global Dermatology Times App DermatologyTimes.com/atopicdermatitis magenta cyan yellow black Dermatology Times is part of the ModernMedicine Network, a Web-based portal for health professionals offering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge-sharing among members of our community. Get access to all the benefits Dermatology Times offers at your fingertips. The Dermatology Times app for iPad & iPhone is now free in the iTunes store. ES557023_DT0215_003.pgs 01.22.2015 00:37 ADV placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla IMPORTANT SAFETY INFORMATION (cont’d) Warnings and Precautions (cont’d) for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur ◆ Weight Decrease: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with ◆ Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended Adverse Reactions Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4). ◆ Use in Specific Populations ◆ Pregnancy and Nursing Mothers: Otezla is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when Otezla is administered to a nursing woman ◆ Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information Please turn the next page for Brief Summary of Full Prescribing Information. References: 1. Schafer PH, Parton A, Capone L, et al. Cell Signal. 2014;26:2016-2029. 2. Otezla [package insert]. Summit, NJ: Celgene Corporation; 2014. 3. Data on file, Celgene Corporation. Otezla® is a registered trademark of Celgene Corporation. © 2014 Celgene Corporation 09/14 USII-APR130019h magenta cyan yellow black ES555300_DT0215_004_FP.pgs 01.17.2015 00:13 ADV ◆ Otezla® (apremilast) was evaluated in 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients with moderate to severe plaque psoriasis (N = 1257) were randomized 2:1 to Otezla 30 mg or placebo twice daily for 16 weeks, after a 5-day titration2,3 ◆ Inclusion criteria: Age ≥18 years, BSA involvement ≥10%, sPGA ≥3, PASI score ≥12, candidates for phototherapy or systemic therapy2 ◆ PASI-75 response at week 16 (primary endpoint)2,3 – Study 1: Otezla 33% vs placebo 5% (P < 0.0001) – Similar PASI-75 response was achieved in Study 2 BSA, body surface area; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment. IMPORTANT SAFETY INFORMATION Contraindications ◆ Otezla® is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation Warnings and Precautions Depression: Treatment with Otezla is associated with an increase in adverse reactions of depression ◆ During clinical trials, 1.3% (12/920) of patients treated with Otezla reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of Otezla patients discontinued treatment due to depression compared with none on placebo (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide Carefully weigh the risks and benefits of treatment with Otezla Continued to the left Get the latest news at otezlapro.com magenta cyan yellow black ES555299_DT0215_005_FP.pgs 01.17.2015 00:13 ADV Rx Only OTEZLA® (apremilast) tablets, for oral use The following is a Brief Summary; refer to Full Prescribing Information for complete product information. INDICATIONS AND USAGE OTEZLA® (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. CONTRAINDICATIONS OTEZLA is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Adverse Reactions (6.1)]. WARNINGS AND PRECAUTIONS Depression: Treatment with OTEZLA is associated with an increase in adverse reactions of depression. Before using OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment with OTEZLA in such patients. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with OTEZLA if such events occur. During the 0 to 16 week placebocontrolled period of the 3 controlled clinical trials, 1.3% (12/920) of patients treated with OTEZLA reported depression compared to 0.4% (2/506) treated with placebo. During the clinical trials, 0.1% (1/1308) of patients treated with OTEZLA discontinued treatment due to depression compared with none in placebo-treated patients (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to OTEZLA, compared to none in placebo-treated patients (0/506). Instances of suicidal behavior have been observed in 0.1% (1/1308) of patients while receiving OTEZLA, compared to 0.2% (1/506) in placebo-treated patients. In the clinical trials, one patient treated with OTEZLA attempted suicide while one who received placebo committed suicide. Weight Decrease: During the controlled period of the trials in psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (96/784) of patients treated with OTEZLA compared to 5% (19/382) treated with placebo. Weight decrease of ≥ 10% of body weight occurred in 2% (16/784) of patients treated with OTEZLA 30 mg twice daily compared to 1% (3/382) patients treated with placebo. Patients treated with OTEZLA should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of OTEZLA should be considered. Drug Interactions: Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of OTEZLA. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA is not recommended [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. ADVERSE REACTIONS Clinical Trials Experience in Psoriasis: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial 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. Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for patients taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of patients with psoriasis who discontinued treatment due to any adverse reaction was 6.1% for patients treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated patients. Table 3: Adverse Reactions Reported in ≥1% of Patients on OTEZLA and With Greater Frequency Than in Patients on Placebo; up to Day 112 (Week 16) Table 3: Adverse Reactions Reported in ≥1% of Patients on OTEZLA and With Greater Frequency Than in Patients on Placebo; up to Day 112 (Week 16) Placebo (N=506) n (%) OTEZLA 30 mg BID (N=920) n (%) Dyspepsia 6 (1) 29 (3) Decrease appetite 5 (1) 26 (3) Preferred Term Insomnia 4 (1) 21 (2) Back pain 4 (1) 20 (2) Migraine 5 (1) 19 (2) Frequent bowel movements 1 (0) 17 (2) Depression 2 (0) 12 (1) Bronchitis 2 (0) 12 (1) Tooth abscess 0 (0) 10 (1) Folliculitis 0 (0) 9 (1) Sinus headache 0 (0) 9 (1) *Two subjects treated with OTEZLA experienced serious adverse reaction of abdominal pain. Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) patients following discontinuation of treatment with OTEZLA (apremilast). DRUG INTERACTIONS Strong CYP 450 Inducers: Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers (such as rifampin) and may result in loss of efficacy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C : OTEZLA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OTEZLA during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972. Nursing Mothers: It is not known whether OTEZLA or its metabolites are present in human milk. Because many drugs are present in human milk, caution should be exercised when OTEZLA is administered to a nursing woman. Pediatric use: The safety and effectiveness of OTEZLA in pediatric patients less than 18 years of age have not been established. Geriatric use: Of the 1257 patients who enrolled in two placebo-controlled psoriasis trials (PSOR 1 and PSOR 2), a total of 108 psoriasis patients were 65 years of age and older, including 9 patients who were 75 years of age and older. No overall differences were observed in the efficacy and safety in elderly patients ≥ 65 years of age and younger adult patients <65 years of age in the clinical trials. Renal Impairment: OTEZLA pharmacokinetics were not characterized in patients with mild (creatinine clearance of 60-89 mL per minute estimated by the Cockcroft–Gault equation) or moderate (creatinine clearance of 30-59 mL per minute estimated by the Cockroft–Gault equation) renal impairment. The dose of OTEZLA should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft–Gault equation) [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. Hepatic Impairment: Apremilast pharmacokinetics were characterized in patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment. No dose adjustment is necessary in these patients. OVERDOSAGE In case of overdose, patients should seek immediate medical help. Patients should be managed by symptomatic and supportive care should there be an overdose. Placebo (N=506) n (%) OTEZLA 30 mg BID (N=920) n (%) Manufactured for: Celgene Corporation, Summit, NJ 07901 Diarrhea 32 (6) 160 (17) OTEZLA® is a registered trademark of Celgene Corporation. Nausea 35 (7) 155 (17) Upper respiratory tract infection 31 (6) 84 (9) Tension headache 21 (4) 75 (8) Headache 19 (4) 55 (6) Abdominal pain* 11 (2) 39 (4) Vomiting 8 (2) 35 (4) Fatigue 9 (2) 29 (3) Preferred Term Pat. http://www.celgene.com/therapies ©2014 Celgene Corporation, All Rights Reserved. Based on APRPI.003 OTZ_PsO_HCP_BSv.003 09_2014 (continued) black ES555296_DT0215_006_FP.pgs 01.17.2015 00:13 ADV FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM EDITORIAL ADVISORY BOARD 7 Insight & Opinion From Our Advisory Board Leaders content CONTENT CHANNEL DIRECTOR Heather Onorati } (440) 826-2868 [email protected] CONTENT MANAGING EDITOR Pamela Kreigh } (440) 891-2610 [email protected] AESTHETIC CONTENT EDITOR Eliza Cabana } (440) 891-2671 [email protected] CONTENT SPECIALIST COSMETIC COLUMNIST LASER & LIGHT DEVICES COLUMNIST LEGAL AFFAIRS COLUMNIST GROUP ART DIRECTOR ART DIRECTOR SENIOR PRODUCTION MANAGER The Dermatology Times Editorial Advisory Board qualifies the editorial content of the magazine. Members review meeting programs; suggest story topics, special reports and sources; evaluate manuscripts; conduct interviews and roundtables; and counsel editors as questions arise. Annamarie Iannetta } (440) 891-2606 [email protected] Zoe Diana Draelos, M.D. Joely Kaufman, M.D. David J. 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CEO Joe Loggia EVP, CAO & CFO Tom Ehardt EVP Georgiann DeCenzo EVP Chris DeMoulin EVP, BUSINESS SYSTEMS Rebecca Evangelou EVP, HUMAN RESOURCES Julie Molleston EVP, STRATEGY & BUSINESS DEVELOPMENT SR VICE-PRESIDENT VP, GM PHARM/SCIENCE GROUP VP, LEGAL VP, MEDIA OPERATIONS VP, TREASURER & CONTROLLER Our Mission Dermatology Times is the only clinical news resource serving a readership of more than 14,000 dermatologists and other professionals focused on skincare. Through unbiased reporting, we strive to help practitioners put into perspective developments that affect their business. Our goal is to provide practical information that will help them to better understand clinical, regulatory and financial issues, as well as chart business growth. Mike Alic Tracy Harris Dave Esola Michael Bernstein Francis Heid Adele Hartwick PRINTED IN U.S.A. magenta cyan yellow black Let your voice be heard, contact us: [email protected] ES556507_DT0215_007.pgs 01.21.2015 01:37 ADV 8 EDITORIAL ADVISORY BOARD FEBRUARY 2015 ® ∕ DERMATOLOGYTIMES.COM Insight & Opinion from Our Advisory Board Leaders Zoe Diana Draelos, M.D., is a Dermatology Times editorial adviser and consulting professor of dermatology, Duke University School of Medicine, Durham, N.C. A new product category: pharmacoids ermatologics are entering a new era. The first agents that were developed to treat skin disease were cleansers, originally known as soaps. Soaps were first discovered by man upon examining the ashes of an animal carcass cooked over a wood fire. The combination of potash from burnt wood ash and hydrolyzed animal fat triglycerides yielded potassium soap and glycerol observed as a waxy material in the fire remains. Commercially available hand made soap sold in the ninth and tenth centuries was a possession of the rich with mass use of soap beginning in the early 1900s. As a matter of fact, soap was a major import of the US from France and Italy until 1878 when domestic mass manufacturing began. Today soap is an unclassified substance that is neither a cosmetic nor a drug, since the federal government decided that the regulation of cleansers would possibly increase the cost limiting access to this important mechanism for infection prevention. D The second agents that were developed to treat skin disease were cosmetics. While we presently think of eye shadows, eyeliners and lipsticks as products to color and adorn the face, indeed they were originally purposed to prevent infection through the use of ground natural materials with antibacterial properties. Today we recognize cosmetics as items used for appearance purposes only that do not modify the structure or function of the skin. The third category of skin products developed were the pharmaceuticals that dermatologists presently prescribe encompassing more variety in formulation than any other area of medicine. While most physicians prescribe only pills or injections, dermatologists prescribe creams, ointments, lotions, gels, suspensions, powders, and sprays, in addition to pills and injections. Over-the-counter drugs that are formulated based on ingredients, ingredient combinations, ingredient concentrations specified in a monograph, We now enter the new era of dermatology where we have prescription products ... They are temporary in nature, much like a cosmetic, requiring daily application to maintain the optimal effect, yet addressing the appearance need of reduced facial redness. magenta cyan yellow black are a subset also widely utilized by dermatology to include sunscreens, antiperspirants and skin protectants. A NEW CATEGORY OF PRODUCTS A newer category of dermatologic products includes active cosmetics, also known as cosmeceuticals. The term cosmeceuticals is not recognized by the United States government and thus has no regulatory meaning, as cosmeceuticals are simply cosmetics described previously, and nothing more. But, we now enter the new era of dermatology where we have prescription products that temporarily change the color of facial skin. These products are indeed pharmaceuticals, as they have been approved by the Food and Drug Administration, are only available for purchase with a prescription, and are covered by many insurance companies. They are temporary in nature, much like a cosmetic, requiring daily application to maintain the optimal effect, yet addressing the appearance need of reduced facial redness. Indeed, rosacea is a disease where facial redness is part of the disease presentation; thus, this is the indication for which these drugs are prescribed. These unique pharmaceuticals are in many ways the newest category of products to grace our armamentarium. They are drugs that improve appearance temporarily in those with disease. What are they? They are pharmacoids! A word I propose to linguistically convey the concept that these pharmaceuticals bridge the borders of the newest dermatologic medicinal frontier. DT ES556508_DT0215_008.pgs 01.21.2015 01:37 ADV “THANKS, DOC.” When you tell your patients about Mederma ®, they’ll get the #1 doctor-recommended 1 brand for scars. Plus, they’ll get confidence from using products that are clinically shown to improve the appearance of scars and stretch marks. Because the only thing more powerful than making people feel better is making people feel better about themselves. Mederma® PM Intensive Overnight Scar Cream, the first scar therapy formulated to work with skin’s nighttime regenerative activity. Call 1-888-925-8989 to request samples and literature. 1 IMS Health. NDTI, December 2013 ©/®/™ 2015 Merz North America, Inc. magenta cyan yellow black ES555291_DT0215_009_FP.pgs 01.17.2015 00:12 ADV 10 LEGAL ® EAGLE FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM David J. Goldberg, M.D., J.D. is director of Skin Laser and 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. My actions were innocuous. Did I commit fraud? D r. Derm has run an honest, reputable, successful dermatology practice for 30 years. She is respected by her colleagues and loved by her patients. Her usual Medicare office visit charge of $45 is considered reasonable and customary by all of the managed care providers in her service area. Unfortunately, Dr. Derm’s office manager becomes ill, and the doctor hires an insurance/billing specialist. The specialist notes that the $45 is a minimal amount of money when compared with the effort undertaken by the physician. He suggests that the dermatologist simply upcode, without changing the $45 fee; with this, reimbursements will be improved. Since the fee charged would not be changed, he innocently suggests, there can be no harm. He further explains to Dr. Derm that her coding could be undertaken in an honest, yet more aggressive, manner. Dr. Derm takes this advice and assumes that since she is not charging more than the original $45 fee, there cannot be a problem. Unfortunately, her “level of care” documentation is abysmal. In one year she bills 1,000 patients in this manner. She continues to provide impeccable care, but unfortunately she receives a Medicare audit that suggests fraud on her part. She is convinced that she is innocent. After all, she is still charging the same $45. She knows that if she had better documentation, she could charge higher fees. Is this really fraud? HEALTHCARE FRAUD Only violent crime ranks higher than the white-collar crime of healthcare fraud according to the Department of Justice (DOJ). Ten percent of the DOJ’s financial resources are directed to healthcare fraud. The General Accounting Office claims 10 percent of the trillion dollar magenta cyan yellow black healthcare industry is lost to fraudulent provider claims. The resulting cost to federal and state governments are tens of billions of dollars a year. The numbers have only increased over the past decade. Healthcare fraud is a classic example of a white-collar crime. There are eight major theories of fraud under which a healthcare provider can be prosecuted: ➊ Treatment by fraud (violations of statutes regulating controlled substances, ➋ billing for services not provided, ➌ misrepresenting the nature of services provided, ➍ auto accident scams, ➎ quackery (misrepresenting credentials or remedies), ➏ false cost reports, ➐ illegal remunerations, and ➑ providing unnecessary or substandard health services. The General Accounting Office claims 10 percent of the trillion dollar healthcare industry is lost to fraudulent provider claims. The Healthcare Financing Administration’s Web site notes that the most common forms of fraud include billing for services not provided, misrepresenting the diagnosis to justify payment, soliciting, offering or receiving a kickback, unbundling or “exploding” charges, falsifying plans of treatment and medical records to justify payment, and billing for a service not furnished as billed – so called upcoding. STATUTES ADDRESSING FALSE CLAIMS Both civil and criminal statutes deal with such false claims. The Medicaid and Medicare fraud and abuse laws make it a felony to misrepresent the nature of services rendered and provide for imprisonment, as well as fines. The False Claims Act (FCA) allows the government to recover three times the amount of damage to the government as well as fines up to $10,000 per claim. The FCA also allows private citizens to bring actions in their own name and the name of the government. Referred to as “qui tam” actions, a person bringing such an action (known as a relator) is entitled to share in the proceeds of any recoveries, which result from the action. The financial rewards to a qui tam plaintiff can run in the millions of dollars. By sharing in the government’s recoveries, qui tam actions encourage private individuals to report fraud. The intent of the qui tam provisions, in the FCA, is to encourage “whistleblowers” to assist the government in its pursuit against fraud. A Washington Times journalist once referred to qui tam relators as “bounty hunters.” As with FCA convictions, providers can incur catastrophic losses when prosecuted under the Medicaid and Medicare fraud and abuse laws. The Office of the Inspector General also has administrative authority to exclude providers from the Medicaid and Medicare program. A provider dependent upon these programs for a significant segment of his/her practice can be economically destroyed by such a sanction. Dr. Derm thought her actions were innocuous; she followed the advice of her specialist. It does not matter. Her actions will be considered fraudulent. DT ES556468_DT0215_010.pgs 01.21.2015 01:32 ADV Your patients will feel softer, smoother skin after just one shower Introducing our mildest formula ever, using only our most gentle surfactants—mild enough for infants and your eczema patients New Dove Sensitive Skin Body Wash is the ONLY body wash that includes: • Glycinate for its mildness and excellent lathering ability with a clean rinse • DEFI* to preserve and replenish skin lipids, and • NutriumMoisture®, a unique blend of 100% skin-natural moisturizers that can be fully absorbed in the skin For the mildness and moisturization you want and the results your patients will love • Only Dove is proven to replenish stearic acid, a fatty acid that is easily removed during cleansing, at a 1-to-1 ratio NEW *Directly Esterified Fatty Isethionate. © 2014 Unilever magenta cyan yellow black ES555388_DT0215_011_FP.pgs 01.17.2015 01:25 ADV 12 ADVANCES HUMAN COLLAGEN COMPOSITE COMPARED AGAINST COMMERCIAL FILLERS Journal of Microbiology and Biotechnology December 2014 A team of Korean researchers has developed a composite filler made of cross-linked hyaluronic acid (HA) and human collagen (COL) derived from the umbilical cord. The researchers, from CHA University in Pocheon, South Korea, write that their goal was to improve the kind of biocompatibility and durability found in commercially available fillers. With that in mind, the researchers made HA /COL composite fillers in two distinct ratios: one at 10:1, the other at 5:1. To evaluate their biocompatibility and durability in vivo, the researchers injected the composite fillers into nude mice subcutaneously. Interior morphologies and in vivo degradation were characterized at one to 16 weeks after injection. The variations of injected gel weight were measured and compared with commercial dermal fillers Restylane and TheraFill. The authors write that the composites showed improved or similar physical properties over the commercial fillers. Sixteen weeks after injection, the ratio of remaining composite filler weight to initial weight was greater than that of either of the commercial fillers. In addition, immunohistochemical analysis with angiogenesis-related markers revealed newly formed blood vessels and cellular influx into the composite filler — something that was not observed with the commercial fillers. “These results clearly suggest that the HA/COL composite filler is a superior candidate for soft-tissue reconstruction,” the authors write. “The filler we developed may be a suitable candidate as an injectable dermal filler for tissue augmentation in humans.” DT — Bill Gillette Read the study bit.ly/humancollagen magenta cyan yellow black FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Study identifies molecular mechanisms behind AD Journal of Allergy and Clinical Immunology December 2014 Atopic dermatitis is an immune-driven disease at the molecular level, according to results of a new study. The study, headed by researchers at the Icahn School of Medicine at New York’s Mount Sinai Hospital, was conducted in collaboration with Regenoron Pharmaceuticals, Sanofi and Rockefeller University. Previous studies have found that drugs that broadly suppress the immune system reduce AD symptoms, but those studies did not describe the molecular mechanisms involved. Some research pointed to genetic or environmental factors as being greater contributors to risk, according to a Mount Sinai news release. The current study found that the investigational drug dupilumab (Regeneron Pharmaceuticals), a monoclonal antibody treatment that blocks the action of signaling proteins interleukin (IL)-4 and -13, reversed disease processes seen in the skin at the molecular level. Dupilumab is in clinical trials for several conditions with immune or autoimmune mechanisms. “Our pioneering study showed that the abnormalities in the skin barrier and in the immune system that characterize atopic dermatitis can be reversed by drugs that narrowly target just these two immune signaling proteins,” lead author Emma Guttman-Yassky, M.D., associate professor of dermatology at the Icahn School of Medicine, said in a news release, Patients treated with dupilumab experienced significant clinical improvements compared with those who were given a placebo. Improvements included reversal of the abnormalities that characterize AD in skin tissues within four weeks of the dupilumab treatment, according to the release. According to Dr. Guttman-Yassky, the study is the first involving a drug “that targets specific immune proteins in atopic dermatitis where mechanistic changes track closely with clinical measures of disease and relief from it.” The researchers say it’s uncertain when phase 3 studies will be completed, but add that new AD drugs should be available in the next few years. DT — Bill Gillette Read the study bit.ly/ADmolecularmechanisms EXPERIMENTAL SMALL MOLECULE INHIBITOR SHOWS PROMISE AS MELANOMA TREATMENT OPTION Molecular Cancer Therapeutics, November 2014 tent inhibitor of a known melanoma pathway. It was highly effective against melanoma and the method of our study – using TAK-33 inhibited and regressed tumor patient-derived tumor samples grown in growth in melanoma cell lines and patientmice – makes us especially optimistic derived xenograft models. This “robust” that we should see similar results success in the lab justifies continin the human disease,” study auued clinical development as a pothor John Tentler, Ph.D., associtential therapy for melanoma paate professor in medicine at Unitients, a recent study suggests. The amount versity of Colorado says in a UniUniversity of Colorado Cancer of tumor versity of Colorado Cancer Center Center researchers studied melashrinkage in press release. noma samples, using patient-deThe FDA approved vemurafenib rived xenografts, which are human 10 of 11 tumor samples to treat BRAF-mutant melanoma melanomas grown in mice. They rein 2011. But while vemurafenib reported anti-cancer activity in 10 of sponse rates are around 80 percent 11 tumor samples treated with TAKfor patients with BRAF mutations, 733. Treated tumors shrunk from response duration often is limited zero to 100 percent. to two to 18 months. In the study’s While TAK-733 is a second-generPERCENT abstract, authors reported partication inhibitor in patients with BRAF ular interest in TAK-733’s activmutations, this study suggests drug ity in BRAF WT models, where approved activity in the cancer regardless of BRAF therapies, such as vemurafenib, have not mutation status. Particularly interesting is been shown to be active. DT the activity in BRAF WT (wild type) models, — Lisette Hilton where current approved therapy such as vemurafenib has been reported not to be active. “The importance of this molecule is Read the study bit.ly/smallmoleculeinhibitor that it’s a next-generation and highly po- 0-100 ES556473_DT0215_012.pgs 01.21.2015 01:33 ADV For patients with dry skin INTRODUCING CeraVe Hydrating Cleanser Bar ® • Contains 5% CeraVe® Moisturizing Cream, unlike any other cleansing bar • Includes ceramides 1, 3, & 6-II to help repair the skin barrier, plus hyaluronic acid and niacinamide • Gentle, non-irritating formula for normal to dry skin • Non-comedogenic; free of soap, dye, and fragrance *In a clinical study, CeraVe® Hydrating Cleanser Bar was shown to lock in moisture 3 times longer than the leading brand. LOCKS IN MOISTURE LONGER THAN DOVE® BEAUTY BAR1† Percentage of corneometer reading improvement from baseline for CeraVe® Hydrating Cleanser Bar and competitors % improvement from baseline 40 a 35 30 a 25 20 15 10 a a a a CeraVe® Hydrating Cleanser Bar increases skin moisture content for 3x longer than Dove® Sensitive Skin Unscented Beauty Bar and 6x longer than Cetaphil® Daily Cleansing Bar1† a a a a 5 CeraVe® 0 Dove® -5 Cetaphil® -10 15 min 30 min 1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr a(p≤0.05) †Data derived from a bio-instrumental study conducted in 15 female subjects using corneometry. Study was shown to increase moisture content. Measured against Dove® Sensitive Skin Unscented Beauty Bar and Cetaphil® Daily Cleansing Bar. Recommend CeraVe® for long-lasting moisture.1 REFERENCE: 1. Data on file. Valeant Consumer Products. Moisturization study. May 2014. CeraVe is a registered trademark of Valeant Pharmaceuticals International, Inc., or its affiliates. MVE is a registered trademark of DFB Technology, Ltd. Patent No. 6,709,663. All other trademarks are the property of their respective owners. Valeant Consumer Products, a division of Valeant Pharmaceuticals North America. ©2015 Valeant Pharmaceuticals North America SK/CVE/14/0201a 01/15 magenta cyan yellow black www.CeraVe.com ES557425_DT0215_013_FP.pgs 01.22.2015 04:21 ADV 14 CLINICAL DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Skin presentations common in obese patients LOUISE GAGNON | STAFF CORRESPONDENT Obesity is a public health epidemic associated with cardiovascular disease, stroke, and diabetes, but the presence of obesity is also linked to numerous dermatological presentations related to the increased amount of skin and to the pathophysiology of obesity. “Obesity can lead to skin tags,” explains Benjamin Barank in M.D., F.R.C.P.C., a dermatologist based in Toronto, Ontario, Canada and Co-Founder of the Toronto Dermatology Centre. “People who are obese have more skin tags, in more areas, and they are bigger skin tags. Stretch marks also appear more often in obese individuals.” Dr. Barankin notes another condition linked to obesity is acanthosis niObesity may lead to numerous skin presentations in patients of all ages. Shown here, an obese patient with skin tags under the arm (A); a 12-year-old obese child with acanthosis nigricans in the armpit (B); and a 44 year-old obese patient with acanthosis nigricans and skin tags of the neck (C). (A) Photos: Benjamin Barankin, M.D. QUICK READ Several skin presentations in obese patients are associated with the presence of excess skin while others are associated with the pathophysiology of obesity. Dermatologists should have a conversation about weight loss with obese patients. gricans, a thickening and darkening of the skin in sites like the armpits, groin, neck and other intertriginous areas. General thickening of the skin and darkening of the elbows and knees is common in larger patients compared to patients of normal weight, Dr. Barankin adds. Infections, both bacterial and fungal, are also more common in obese than non-obese patients, he says. (B) (C) “If a patient is bothered by his or her psoriasis, here is another reason to take steps like see a dietician, lose weight, and exercise more.” Benjamin Barankin M.D. Toronto PATIENT COUNSELING A condition like hidradenitis suppurativa is associated with the carriage of excess weight, as is chronic plaque psoriasis, and shedding excess weight is associated with improvements in those conditions, a point that creates an opportunity for dermatologists to communicate with their patients about how they can influence their disADULT OBESITY see page 17 DTExtra The Food and Drug Administration approved Bellafill (Suneva Medical) for the treatment of acne scars. It is the first dermal filler to win the agency’s approval for that indication. The approval was based on a placebo-controlled study at 10 clinical centers in which the researchers found that, at six months, the response rate for Bellafill was 64 percent, as compared with 33 percent for placebo. At 12 months, Bellafill registered a response rate of 71 percent as measured by an unblinded assessment. READ MORE: BIT.LY/ACNESCARTHERAPY magenta cyan yellow black ES556973_DT0215_014.pgs 01.21.2015 23:19 ADV HELP THEM LOOK FORWARD TO CLEARER SKIN WITH EPIDUO GEL— • Early results and the power to help prevent future breakouts1-4 • The ONLY antibiotic-free xed-dose combination Prescribe # THE BRANDED TOPICAL ACNE PRODUCT AMONG DERMATOLOGISTS AND PEDIATRICIANS5 1 Important Safety Information Indication: EPIDUO® (adapalene and benzoyl peroxide) Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (≥1%) in patients treated with EPIDUO® Gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. Warnings/Precautions: Patients taking EPIDUO® Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of EPIDUO® Gel and may necessitate discontinuation. You are encouraged to report negative side efects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see brief summary of full Prescribing Information on next page. magenta cyan yellow black ES555371_DT0215_015_FP.pgs 01.17.2015 01:24 ADV IMPORTANT INFORMATION ABOUT ® EPIDUO GEL (adapalene and benzoyl peroxide) Gel, 0.1% / 2.5% BRIEF SUMMARY WHAT ARE THE MOST COMMON SIDE EFFECTS OF EPIDUO GEL? This summary contains important information about EPIDUO (EP-E-Do-Oh) gel. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you start using EPIDUO gel. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about EPIDUO gel. For full Prescribing Information and Patient Information please see the package insert. WHAT IS EPIDUO GEL? EPIDUO gel is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age or older. Acne vulgaris is a condition in which the skin has blackheads, whiteheads, and pimples. The most commonly reported side effects when using EPIDUO gel include erythema, scaling, dryness, application site irritation, stinging and burning. Depending upon the severity of these side effects, patients should be instructed to use a moisturizer, reduce the frequency of the application of EPIDUO gel, or discontinue use. Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using EPIDUO gel. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of EPIDUO gel. For more information, ask your doctor or pharmacist. WHO IS EPIDUO GEL FOR? EPIDUO gel is for use in people 9 years of age and older. It is not known if EPIDUO gel is safe and effective for children younger than 9 years old. You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA LABORATORIES, L.P. at 1-866-735-4137. Do not use EPIDUO gel for a condition for which it was not prescribed. Do not give EPIDUO gel to other people, even if they have the same symptoms you have. It may harm them. HOW SHOULD I USE EPIDUO GEL? • Use EPIDUO gel exactly as your doctor tells you to use it. EPIDUO gel is for skin use only. Do not use EPIDUO gel in or on your mouth, eyes, or vagina. • Apply EPIDUO gel 1 time a day. • Do not use more EPIDUO gel than you need to cover the treatment area. Using too much EPIDUO gel or using it more than 1 time a day may increase your chance of skin irritation. WHAT SHOULD I TELL MY DOCTOR BEFORE USING EPIDUO GEL? Before you use EPIDUO gel, tell your doctor if you: • have other skin problems, including cuts or sunburn. • have any other medical conditions. • are pregnant or planning to become pregnant. It is not known if EPIDUO gel can harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if EPIDUO gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use EPIDUO gel. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. • Especially tell your doctor if you use any other medicine for acne. Using EPIDUO gel with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation. • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. WHAT SHOULD I AVOID WHILE USING EPIDUO GEL? • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. EPIDUO gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with EPIDUO gel if you have to be in the sunlight. • You should avoid weather extremes such as wind and cold as this may cause irritation to your skin. • You should avoid applying EPIDUO gel to cuts, abrasions and sunburned skin. • You should avoid skin products that may dry or irritate your skin such as harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol. • You should avoid the use of “waxing” as a hair removal method on skin treated with EPIDUO gel. • EPIDUO gel may bleach your clothes or hair. Allow EPIDUO gel to dry completely before dressing to prevent bleaching of your clothes. APPLYING EPIDUO GEL: • Wash the area where the gel will be applied with a mild cleanser and pat dry. • EPIDUO gel comes in a tube and a pump. If you have been prescribed the: ο Tube: Squeeze a small amount (about the size of a pea) of EPIDUO gel onto your fingertips and spread a thin layer over the affected area. ο Pump: Depress the pump to dispense a small amount (about the size of a pea) of EPIDUO gel and spread a thin layer over the affected area. WHERE SHOULD I GO FOR MORE INFORMATION ABOUT EPIDUO GEL? • Talk to your doctor or pharmacist • Go to www.epiduo.com or call 1-866-735-4137 GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Revised: February 2013 References: 1. Gollnick HPM, Draelos Z, Glenn MJ, et al; Adapalene–BPO Study Group. Adapalene–benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients. Br J Dermatol. 2009;161(5):1180-1189. 2. Czernielewski J, Michel S, Bouclier M, Baker M, Hensby C. Adapalene biochemistry and the evolution of a new topical retinoid for treatment of acne. J Eur Acad Dermatol Venereol. 2001;15(suppl 3):5-12. 3. Phase 3 (CSR 18088). Data on file. Galderma Laboratories, L.P. 4. Pariser DM, Westmoreland P, Morris A, Gold MH, Liu Y, Graeber M. Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris. J Drugs Dermatol. 2007;6(9):899-905. 5. According to data from Symphony Health Solutions, Pharmaceutical Audit Suite, Retail Audit, July 2013-June 2014. All trademarks are the property of their respective owners. ©2014 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EPID-280B Printed in USA 12/14 black www.epiduo.com/hcp ES555297_DT0215_016_FP.pgs 01.17.2015 00:13 ADV FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM CLINICAL DERMATOLOGY 17 ADULT OBESITY: Some chronic conditions worsen with obesity; bariatric skin heals poorly from page 14 ease course through their diet and activity, Dr. Barankin explains. “We are always looking for reasons for people to adopt healthy lifestyle choices and behaviours,” Dr. Barankin says, stressing obesity exacerbates psoriasis. “If a patient is bothered by his or her psoriasis, here is another reason to take steps like see a dietician, lose weight, and exercise more.” “The cardiologist will tell patients obesity is bad for the heart, and an orthopedist will tell patients that obesity is bad for the knees. They (patients) have to understand the repercussions (of obesity) to their skin health.” Laurie Parsons M.D., F.R.C.P.C. Calgary, Alberta, Canada OBESITY, PSORIASIS LINK Indeed, there is strong relationship between obesity and psoriasis, likely based on shared inflammatory pathways. “There is clear evidence linking obesity and psoriasis,” Melissa Peck Piliang M.D., a dermatologist at the Cleveland Clinic in Cleveland, Ohio, told MedPage Today. “Patients who are obese are at higher risk of developing psoriasis, and they have more treatment-resistant psoriasis.” Dr. Piliang noted that cytokines elevated in patients who are obese are the same ones that lead to psoriasis and psoriatic arthritis. “Obesity complicates treatment of psoriasis,” Dr. Pilian told Dermatol- magenta cyan yellow black ogy Times. “Many biologic medications are less effective in obese patients and require a higher dose. The higher dosing regimen can significantly increase the cost of treatment.” Dr. Barankin agrees that the efficacy of psoriasis therapies is often compromised in obese patients. “You have to use a larger dose of drug to be distributed to a larger area,” Dr. Barankin explains. “Some drugs, however, come in a fixed dose, and you can’t increase the dose. If you look at biologics such as etanercept or adalimumab, they may not work as well if they have to be distributed in a larger area.” If patients lose weight, “the drug needs to be distributed to a smaller volume,” so patients will do often better with treatment, Dr. Barankin adds. BARIATRIC SKIN AND WOUND CARE At the recent meeting of the Canadian Wound Care Association, clinicians discussed issues around bariatric skin and wound care. “Bariatric skin often heals poorly,” e x pl a i n s L au r ie P a r s on s M . D., F.R.C.P.C., Medical Director of the Southern Alberta Wound Clinic in Calgar y, Alberta, Canada, and assistant clinical professor of dermatology at the University of Calgary in Calgary, Alberta, Canada. “There are more inflammatory cells in adipose tissue, and these cells contribute to stiffening of connective tissue.” As a result, Dr. Parsons explains there is diminished perfusion of oxygen from vessel to the tissue, making tissue relatively hypoxic. “If the tissue is hypoxic, it takes longer for an injury to heal, and it heals poorly,” Dr. Parsons notes. “If you have tissue that is not well oxygenated, you are certainly more prone to infection. Macrophages need oxygen to kill bacteria. Consequently, when they (obese patients) get their wounds, they are harder to heal.” The frequent co-morbid presentation of diabetes with obesity impairs the wound healing process, Dr. Parsons adds. Another consideration are the skin folds in the moist, intertriginous zones of obese patients, which are an ideal set- ting for yeasts like Candida, with lesions developing under the breasts, under abdominal folds, and in inguinal areas, Dr. Parsons says. “Obesity complicates treatment of psoriasis. Many biologic medications are less effective in obese patients and require a higher dose. The higher dosing regimen can significantly increase the cost of treatment.” Melissa Peck Piliang M.D., Cleveland, Ohio “Treating yeast infections in the skin folds is important,” Dr. Parsons says. “We need to use non-talcum powder to absorb moisture and make sure that skin folds are cleansed properly on a daily basis, and this is particularly true in the morbidly obese patients where moisture-associated skin damage can result in skin ulcers.” The conversation about weight loss is one that a dermatologist should try to have with an obese patient, according to Dr. Parsons. “The cardiologist will tell patients obesity is bad for the heart, and an orthopedist will tell patients that obesity is bad for the knees,” Dr. Parsons says. “They (patients) have to understand the repercussions (of obesity) to their skin health.” DT Drs. Barankin, Piliang, and Parsons all report no relevant disclosures. ES556974_DT0215_017.pgs 01.21.2015 23:19 ADV 18 CLINICAL DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM WEARABLE TECHNOLOGY: Integrating device platforms with the skin from page 1 tegration between the device platform and the skin, in a way that can conform to the textures of the skin and follow the motions and the natural processes of the skin without constraint,” Dr. Rogers says. STUDIES WELL UNDERWAY He says there are two implications for the wearable technology’s use. One is as a continuous monitoring system, which uses the skin as a window for measuring physiological status and health. The other is as a diagnostic tool with utility in a clinical or hospital environment. The devices would be softly laminated onto the skin to measure critical skin properties, which would help clinicians determine courses of action related to skin disorders, including cancers of the skin, as well as healing of surface wounds or surgical sites. Murad Alam, M.D., professor of dermatology, otolaryngology and surgery at Northwestern University Feinberg School of Medicine, Chicago, and colleagues have used the electronic bandage technology to better understand wound healing in skin. “Specifically, we have placed the bandage next to patients’ healing wounds after surgery, including both wounds that had been closed with stitches and those that were left to heal by themselves, to understand how conditions at the wounds change over time,” Dr. Alam says. “We know that temperature, tension, and water content of skin changes as wounds heal, and this technology allows us to non-invasively obtain precise QUICK READ Wearable technology is being worked into forms that look and feel like the skin itself. Devices would be softly laminated onto the skin to measure critical skin properties, which would help clinicians determine courses of action related to skin disorders, including cancers of the skin, as well as healing of surface wounds or surgical sites. information about these and other factors minute by minute and even second by second.” The technologyispatient-friendly and highly accurate, he says. “For instance, we can tell temperature at the site to within hundredths or thousandths of a degree, a level of accuracy previously only achievable with big and cumbersome temperature detectors,” Dr. Alam says. “As we use the electronic bandages to collect more of this information about small changes A test platform for basic electronic building blocks and skin sensors placed on the wrist. Photo: John Rogers, Ph.D. during wound healing, we will be better able to understand exactly how wound healing works. This may, in turn, help us develop better dressings, medicines, and techniques to speed wound healing and improve scars.” The technology’s potential applications in continuous monitoring, sports and fitness and in beauty-related products are numerous. “We’re interested in all of them,” Dr. Rogers says. Dr. Rogers and colleagues are collaborating with L’Oreal on a commercial product (which he can’t yet discuss) and on basic research to study the skin’s properties, like skin stiffness, mechanical properties, hydration level, UV exposure and temperature distribution. “We’ve explored and developed new sensor modalities that coincide with what L’Oreal feels is important. Part of it is scientific discovery. Part of it is aimed at establishing foundations for measurement protocols that they can use internally in their own research … as they develop new products for the skin,” Dr. Rogers says. “The kinds of systems that they use now are comparable to clinical gold standard measurement interfaces that you would see in hospital settings for hydration, for example. But those [other] devices are big, bulky instruments with lots of disadvantages and measurement limitations.” There’s also research with the department dermatology at University of Arizona Medical Center, according to Dr. Rogers. WEARABLE TECHNOLOGY see page 21 Links to study abstracts on wearable technology ▶ DAGDEVIREN C, YANG BD, Su Y, Tran PL, Joe P, Anderson E, Xia J, Doraiswamy V, Dehdashti B, Feng X, Lu B, Poston R, Khalpey Z, Ghaffari R, Huang Y, Slepian MJ, Rogers JA. Conformal piezoelectric energy harvesting and storage from motions of the heart, lung, and diaphragm. Proc Natl Acad Sci U S A. 2014 Feb 4;111(5):1927-32. Epub 2014 Jan 21. http://www.ncbi. nlm.nih.gov/pubmed/?term=rogers+ja +wearable+technology magenta cyan yellow black ▶ Kim J, Banks A, Cheng H, Xie Z, Xu S, Jang KI, Lee JW, Liu Z, Gutruf P, Huang X, Wei P, Liu F, Li K, Dalal M, Ghaffari R, Feng X, Huang Y, Gupta S, Paik U, Rogers JA. Epidermal Electronics with Advanced Capabilities in Near-Field Communication. Small. 2014 Nov 3. http://www.ncbi.nlm.nih. gov/pubmed/25367846 ▶ Jang KI, Han SY, Xu S, Mathewson KE, Zhang Y, Jeong JW, Kim GT, Webb RC, Lee JW, Dawidczyk TJ, Kim RH, Song YM, Yeo WH, Kim S, Cheng H, Rhee SI, Chung J, Kim B, Chung HU, Lee D, Yang Y, Cho M, Gaspar JG, Carbonari R, Fabiani M, Gratton G, Huang Y, Rogers JA. Rugged and breathable forms of stretchable electronics with adherent composite substrates for transcutaneous monitoring. Nat Commun. 2014 Sep 3;5:4779. http:// www.ncbi.nlm.nih.gov/pubmed/?term =rogers+ja+skin+cancer DT ES557001_DT0215_018.pgs 01.22.2015 00:34 ADV Rosacea: The physical and emotional toll Published as a promotional supplement to February 2015 By Scott Kober, MBA, CCMEP osacea is a chronic cutaneous disorder that primarily affects the central face, including the cheeks, eyes, nose, chin, and forehead. It is important to note that there is not a specific characteristic or set of characteristics that define rosacea. Rather, there are specific features that vary in presentation and magnitude among patients (Table 1).1 Although the pathophysiology of rosacea is not yet completely understood, it is believed to involve both the innate and adaptive immune systems. Patients with rosacea often have abnormal regulation of the neurovascular system. Vascular abnormalities, microbial activity, and pilosebaceous gland abnormalities may also exacerbate the condition.2 Clinical studies have shown that patients with rosacea have a high concentration of cathelicidinderived peptide (LL-37), which can contribute to inflammation.3 Recent research has also focused on the possible influence of Demodex mites on the pathophysiology of rosacea, showing that Demodex density is almost 6 times higher in patients with rosacea than it is in the normal population.4 Rosacea affects up to 10% of the general population, with the greatest prevalence in individuals aged 30 to 50 years. Although most common in light-skinned individuals of Northern European descent, rosacea is not exclusive to Caucasians and can be seen, albeit with less frequency, in Asians, Hispanics, African-Americans, and other demographic groups.5 There is certainly a physical burden associated with rosacea, but the emotional impact of the condition is often even more substantial. Whereas acne is often considered almost a rite of passage for teenagers, many adult rosacea patients avoid going out in public due to psychological factors. A recent National Rosacea Society (NRS) survey of more than 400 rosacea sufferers showed R that 75% had low self-esteem, 70% were “embarrassed” by their condition, and 56% felt robbed of pleasure/happiness.6 In 2002, the NRS identified 4 distinct subgroups of rosacea. Although there may be some overlapping characteristics of these subtypes, the classifications have helped with diagnosis and initial treatment plans:5 Erythematotelangiectatic rosacea: Mainly characterized by flushing and persistent central facial erythema. Telangiectases are common, but not essential for diagnosis. Most common rosacea subtype. Papulopustular rosacea: Characterized by persistent central facial erythema with transient papules or pustules (or both) in a central facial distribution. Papules and pustules may also occur periodically. Resembles acne, except for the presence of comedones. Phymatous rosacea: Characterized by thickening skin, irregular surface nodularities, and enlargement. Predominantly present in male patients. Ocular rosacea: Characterized by watery or bloodshot eyes, foreign body sensation, burning/stinging, dryness, itching, light sensitivity, blurred vision, telangiectases of the conjunctiva and lid margin, or lid and periocular erythema. In addition to rosacea classifications, the NRS also developed a standard grading system to provide a common reference for diagnosis, treatment, and assessment of results in clinical practice. This grading system is commonly used in clinical trials to allow for comparability of results. A modified version of an available grading scorecard is included in Table 2.7 It gives a general overview of the delineation between severity ratings. The determination of rosacea severity is helpful, but it is important for clinicians to do more than simply perform a visual assessment of a patient’s condition as they consider initial steps of treatment. For example, a patient may present with symptoms consistent with mild rosacea, but if they report significant issues with social and/or professional embarrassment due to their appearance, more-aggressive therapy may be warranted. It is also important to keep in mind that despite the general conditioning of many clinicians to expect more psychological strain in women with rosacea, many men with rosacea also report a significant emotional burden. Determining initial treatment options Many patients with rosacea will try over-thecounter medications indicated for the treatment of acne prior to seeking a clinician’s evaluation. Unfortunately, many of these medications will exacerbate rather than ameliorate a rosacea patient’s inflammation. Patients with rosacea have very sensitive skin that results in a prickly or painful feeling with use of certain agents. It is important for clinicians seeing a patient for the first time to gather a thorough medication history that will help determine initial therapeutic steps. At baseline, a gentle skin care and photoprotective regimen should be recommended for all rosacea patients with centrofacial erythema, regardless of the presence of papulopustular lesions. Generally, a sunscreen with an SPF of at least 30 is recommended for protecting against incidental sun exposure.1 Patients who present with centrofacial erythema but without papules or pustules can often be managed with use of a once-daily alpha agonist, which will demonstrate an initial effect within 30 to 60 minutes of application and peak after 3 to 4 hours. Intense pulsed light or laser therapy may also be incorporated into the treatment plan.8 The majority of research in rosacea has focused on the treatment of inflammatory pa- ROSACEA TYPES AND TREATMENTS SUBTYPES: 1: Erythematotelangiectatic Rosacea (Facial Redness) SYMPTOMS: Flushing and persistent redness, may include visible blood vessels, stinging, burning, and swelling 2: Papulopustular Rosacea (Bumps and Pimples) 3: Phymatous Rosacea (Skin Thickening) 4: Ocular Rosacea (Eye Irritation) Bumps (papules) or pimples (pastules) that come and go, includes red patches Excess tissue often results in enlargement of the nose and irregular surface nodules (bump-like lesions) Watery or bloodshot eyes, tearing and burning, swollen eyelids, recurrent styes EXAMPLES: Courtesy of: National Rosacea Society Published as a promotional supplement to Dermatology Times | © 2015 February/2015 magenta cyan yellow black Sponsored by ES555442_DT0215_INSERT1_FP.pgs 01.17.2015 03:30 ADV Rosacea: The physical and emotional toll Coming up next Table 1 Features of rosacea Primary features Secondary features Flushing (transient erythema) Burning or stinging In part 2 of this series, we’ll take a closer look at the newest treatment option for the inflammatory component of rosacea—ivermectin—and discuss how it may fit into the overall treatment armamentarium. Nontransient erythema Phymatous changes Papules and pustules Plaque Telangiectasia Dry appearance References Edema 1. Ocular manifestations Peripheral location Source: Ref 1 2. Table 2 Severity grading of rosacea papules and pustules Rosacea severity Mild Moderate Severe Papules/pustules Plaques Few None Several None Many Present 4. Source: Ref 7 pules and pustules, which can be more difficult to manage. There are currently 2 topical agents approved by FDA for the treatment of inflammatory lesions of rosacea: metronidazole (MTZ; twice-daily 0.75% gel, cream, or lotion, and once-daily 1% gel or cream) and azelaic acid (AZA; twice-daily 15% gel). Also available is modified-release doxycycline 40 mg once daily, a systemic therapy.9,10 MTZ and AZA are most commonly used initially in patients with mild or moderate disease, whereas doxycycline is often initiated in patients with more severe rosacea. Use of a combination regimen of a topical agent with doxycycline is a popular option for some patients. Recent survey data of 300 dermatologists showed that this combination approach is used as initial therapy in 83.7% of patients with moderate-to-severe papulopustular rosacea.11 The overall safety and tolerability profiles of MTZ and AZA are favorable, with the most common adverse events related to local reactions. AZA may cause neurosensory symptoms after application, but these are usually transient and remit within 1 to 2 weeks after initiating a regimen.9 The submicrobial dose of doxycycline was designed to provide anti-inflammatory effects with no antibiotic activity, even with prolonged duration of use for several months. It has been shown to be equally efficacious regardless of a patient’s rosacea severity at baseline. Common side effects include headache, nausea, and vomiting. These side effects have been shown to appear less frequently in the antiinflammatory 40-mg dose compared to the antimicrobial 100-mg dose.12 Setting treatment goals Television advertisements often serve as false idols for patients with rosacea, promising “Results within 24 hours!” or “Skin as clear as you could ever imagine!” Unfortunately, this often creates a wildly inflated sense of expectations among patients that can be difficult to temper. It is vital for rosacea patients to understand that, with anything prescribed for them, improvements are not going to occur overnight. In the majority of phase 2 and 3 clinical trials for agents approved by FDA or in latestage clinical trials, patients are treated for 12 to 16 weeks.9,10,13,14 Although patients can expect to see some improvement in their symptoms within a few weeks of therapy (assuming adherence to the prescribed regimen), it may take 6 to 8 weeks for significant improvement to occur. Even then, there may not be complete resolution of background erythema or inflammatory lesions. Some patients will develop an immediate skin reaction to topical medications, but for those who can tolerate them, a 6- to 8-week trial at minimum should be prescribed to gauge efficacy.8 This can be difficult for some patients who want a more-immediate panacea, which is why a frank, upfront discussion is vital to calm overzealous expectations. Because rosacea is a lifelong condition that may wax and wane over the course of a patient’s lifetime, it is also important to discuss long-term maintenance for patients who do get relief from the use of 1 or more medications. Unfortunately, there are few long-term studies in the published literature that address maintenance of disease control beyond 6 months, so it is often up to clinician judgment and patient tolerance to determine the best course of action for lifelong maintenance of rosacea symptoms.8 Many clinicians will see the same patients multiple times during the course of their lifetime to deal with rosacea flares. These flares can sometimes be managed with a short course of antibiotics but in other instances may require additional topical or systemic therapies. Published as a promotional supplement to Dermatology Times | © 2015 February/2015 magenta cyan yellow black 3. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 1: a status report on the disease state, general measures, and adjunctive skin care. Cutis. 2013;92(5):234–240. Chang BP-Y, Kurian A, Barankin B. Rosacea: an update on medical therapies. Skin Therapy Lett. 2014;19(3):1–4. Del Rosso JQ, Gallo RL, Kircik L, et al. Why is rosacea considered to be an inflammatory disorder? The primary role, clinical relevance, and therapeutic correlations of abnormal innate immune response in rosacea-prone skin. J Drugs Dermatol. 2012;11(6):694–700. Casas C, Paul C, Lahfa M, et al. Quantification of Demodex folliculorum by PCR in rosacea and its relationship to skin innate immune activation. Exp Dermatol. 2012;21(12):906–910. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46(4):584–587. National Rosacea Society. Coping with rosacea: managing psychosocial aspects of rosacea. www.rosacea.org/patients/materials/ coping/managing.php#Managing. Accessed December 24, 2014. Wilkin J, Dahl M, Detmar M, et al. Standing grading system for rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2004;50(6):907–912. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 5: a guide on the management of rosacea. Cutis. 2014;93(3):134–138. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 2: a status report on topical agents. Cutis. 2013;92(6):277–284. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 3: a status report on systemic therapies. Cutis. 2014;93(1):18–28. Del Rosso JQ. Patterns of use of topical and oral therapies in the treatment of different subtypes of rosacea. Presented at the 11th Annual South Beach Symposium; April 11– 15, 2013: Miami Beach, FL. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573– 576. Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791–802. Stein L, Kircik L, Fowler J, et al. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316–323. Sponsored by ES555441_DT0215_INSERT2_FP.pgs 01.17.2015 03:30 ADV FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM CLINICAL DERMATOLOGY 21 CHILDHOOD OBESITY: Obese less likely than normal weight children to see a dermatologist from page 1 Mirmirani told Dermatology Times, noting she was prompted to examine skin disorders in obese children because the subject has not been explored in the literature. She recently published findings based on a retrospective, population-based study of pediatric patients that found, amongst other conclusions, that a greater proportion of insulin resistance disorders, bacterial infection, fungal infection, inflammatory disorders, mechanical changes, like stretch marks and other skin conditions were present in obese subjects compared with normal weight patients.1 It is estimated that one in six children in the United States (16.4 percent) are obese, and 31.6 percent are overweight.2 Dr. Mirmirani used the Centers for Disease Control and Prevention criteria to define obesity in children: Children with a body mass index in the 95th percentile or greater were defined as obese, those overweight were defined as the 85th to 95th percentile, and normal Esp is considered less than the 85th percentile. Interestingly, Dr. Mirmirani did not find that conditions linked to androgen excess, such as acne, or viral infections, such as warts and molluscum, were elevated in obese children. On the contrary, these conditions were significantly less common in obese children. QUICK READ Obese children experience more dermatological concerns than normal weight children, a fact that should motivate dermatologists to counsel pediatric patients and parents about the benefts of weight loss. “We hypothesized that the inflammatory signal associated with excess body fat counteracted other factors leading to viral infections or things like acne,” Dr. Mirmirani explains. “It is a possibility that some of the inflammatory signals decreased susceptibility to viral infections.” Despite greater prevalence of inflammatory conditions in obese children and greater prevalence of bacterial and fungal infections in obese children, the study found obese children were less likely than their normal weight counterparts to have a dermatology encounter. The association between pediatric obesity and cutaneous disorders linked to inflammation and the link between pediatric obesity and bacterial and fungal infections underline the need for dermatologists to communicate the value of behavioural modification, Dr. Mirmirani says. “If you think about the lifetime burden of disease, there will be more of a The rise in childhood obesity has shown an impact on dermatological conditions. The (excess) adipose tissue is having a large effect on the skin, which is noted by a greater prevalence of inflammatory conditions and bacterial and fungal infections. Photo: Paradi Mirmirani, M.D. burden (if children continue to be obese in adulthood),” Dr. Mirmirani says. “If we can intervene early on through including counselling about healthy eating, activity and weight loss, that will have a big impact.” DT Dr. Mirmirani had no relevant disclosures. 1 Mirmirani P, Carpenter DM. Skin disorders associated with obesity in children and adolescents: a population-based study. Pediatr Dermatol. 2014;31(2):183-90. 2 Ogden CL, Carroll MD, Flegal KM. High body mass index for age among US children and adolescents, 2003-2006. JAMA. 2008;299(20):2401-5. WEARABLE TECHNOLOGY: Integrating device platforms with the skin from page 18 “The work in Arizona was focused on measuring the elastic properties — the stiffness of skin — and mapping that around cancer sites on the skin,” he says. The assessments from wearable technology could take the place of or be used in conjunction with the physical touching, pinching and poking that dermatologists and other doctors might do now to assess skin stiffness. THE TRICKY PART In essence, the wearable technology gathers the data for transfer to a computer program, where it can be scientifically assessed. Wearers don’t feel the devices — regardless of what they do, functionally or in their daily activities. “You’re really talking, ultimately, about taking the guts of an iPhone and magenta cyan yellow black rendering it into an ultrathin stretchable format that can go on the skin. There are a lot of fundamental challenges in engineering and material science associated with attempts to doing that,” he says. “But we think we’ve made a lot of progress. We can really do some sophisticated things with these devices.” MORE PUBLISHED STUDIES COMING Most of the studies going on now with the wearable technology are focused on measuring skin hydration, stiffness, temperature — even sweat. The goal would be to capture sweat or access interstitial fluids from the near surface layers of the skin and do chemical analyses on those fluids. “That’s a big area for us from a scientific research standpoint,” Dr. Rogers says. Another focus of research in the area of continuous monitoring is to hone the wireless aspect of the technology and increase its battery life. “I think the ability to keep the device in place and continuously monitor what’s going on would be a powerful capability to allow a doctor to pick up an early sign of an infection, for example, or any kind of abnormality associated with the healing process, and determine a drug treatment on that basis,” Dr. Rogers says. “That’s a longer term vision. W hat we’ve done so far is prove the utility of the sensors and the compatibility with the skin, in the context of that wound healing effort. The wireless continuous monitoring mode is next.” DT ES557004_DT0215_021.pgs 01.22.2015 00:34 ADV 22 COSMETIC DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM TOP DEVICE PICKS 25 EXPERTS’ Advice for choosing the right lasers for your practice HEALTH IN AFRICAN 28 HAIR, AMERICAN WOMEN Unique qualities require special handling Cosmetic surgery and social media infuence in 2015 PATTY REIMAN | STAFF CORRESPONDENT According to a recent survey conducted by RealSelf, social media is influencing patients’ decisions to have cosmetic surgery procedures. The online community suggests that more and more, social media is bringing to light the selfperceived need for cosmetic surgery. A selfie here, a selfie there and those sagging jowls or forehead wrinkles are all over Facebook and a constant reminder of just how much older you look. In fact, patients also are sharing results and posting physician reviews, too. THE SURVEY RealSelf, an online information-sharing community that offers reviews, photos and physician Q&A relating to cosmetic surgery, dermatology and other elective treatments, surveyed 527 of its website visitors recently with a fairly straight-forward question, “Has social media influenced you to consider or choose to have a cosmetic procedure?” QUICK READ More often, social media is bringing to light the self-perceived need for cosmetic surgery. Nearly half confirmed the social media impact, with 15.37 percent answering a flat out “yes,” and 33.40 percent saying, “somewhat, I knew I wanted a change, but photos on social media made me more aware.” According to Tom Seery, founder and CEO of RealSelf, “Connectivity has forever changed the ways prospective patients engage with your practice.” Jason Emer, M.D., a regular physician contributor to RealSelf and practicing cosmetic surgeon agrees with Mr. Seery’s observation. “I have just started out in practice in Beverly Hills, and roughly 60 perDr. Emer cent of my patients Quotable SOCIAL INFLUENCE see page 26 DTExtra I like it because you can treat atrophic acne and traumatic or surgical scars, as well as wrinkles, dyspigmentation, large pores and stretch marks.” Tina Alster, M.D. Washington, D.C. On her nonablative fractional laser See story page 25 are from social media, website postings, online advertising or RealSelf,” he says. “Patients today are highly inf luenced by what others say. They look to partner with you in the decisions about their procedure or treatment,” Mr. Seery notes. “In aesthetics, we’ve seen that half of consumers researched a treatment for more than one year. In this information gathering, people trust opinions of their peers, mainly reviews, and information posted by medical experts, such as answers to questions,” he points out. “To illustrate the significance of social media to a medical practice, I share with doctors [the statistic] that one in four U.S. adults share their health experiences on social media channels.” And that means doctor reviews too. Dr. Emer says even a demanding but satisfied patient can post a rating of three or four (out of five) stars, which gives the impression of a less-than-stellar experience. Or patients might post Researchers at the University of British Columbia, in Vancouver, Canada, performed split-face BoNTA injections on 23 women with eyebrow asymmetry. The amount of drug and injection locations were identical on both sides, with deep injections administered on the side where increased brow lift was needed. There was no significant difference in the change in brow height over four weeks between the sides that had deep versus shallow injections. The researchers believe that the diffusion of BoNT-A between muscle layers precludes accurate targeting of the muscle belly, where the drug would theoretically have the most effect. READ MORE: BIT.LY/SPLITFACE magenta cyan yellow black ES556490_DT0215_022.pgs 01.21.2015 01:33 ADV NOW APPROVED for adolescents ages 12 and older with scalp plaque psoriasis1 r Co t i cost e roi d AC T Vi ta min og L DUAION a D3 an l Experience the combined efficacy and safety of 2 active ingredients with Taclonex® Topical Suspension1,2 Learn more about dual action at www.taclonex.com INDICATION AND USAGE Taclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older and for plaque psoriasis of the scalp in patients 12 to 17 years. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. IMPORTANT SAFETY INFORMATION Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use and should not be applied to the face, axillae, or groin. Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings unless directed by a physician. If hypercalcemia or hypercalciuria develop, discontinue until parameters of calcium metabolism normalize. Taclonex® can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent steroid. Cushing’s syndrome and hyperglycemia may also occur in adults. Pediatric patients are at a greater risk than adults of systemic toxicity, HPA axis suppression and adrenal insufficiency. The most common adverse reactions (≥1%) are folliculitis and burning sensation of skin. Patients who apply Taclonex® to exposed skin should avoid excessive exposure to either natural or artificial sunlight. There are no adequate and well-controlled studies of Taclonex® Topical Suspension in pregnant women. Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients under the age of 12 years have not been established. Please see Brief Summary of Prescribing Information on the following page. References: 1. Taclonex® Topical Suspension [package insert]. Parsippany, NJ: LEO Pharma Inc.; August 2014. 2. Segaert S, Ropke M. The biological rationale for use of vitamin D analogs in combination with corticosteroids for the topical treatment of plaque psoriasis. J Drugs Dermatol. 2013;12(8):e129-e137. LEO, the LEO Lion Design, and Taclonex are registered trademarks of LEO Pharma A/S. Copyright 2014 LEO Pharma Inc. 3428-TS-14-186 November 2014 Printed in USA magenta cyan yellow black ES555294_DT0215_023_FP.pgs 01.17.2015 00:13 ADV , Rx Only BRIEF SUMMARY (See Package Insert for full Prescribing Information). INDICATIONS AND USAGE: Taclonex® Topical Suspension is indicated for the topical treatment of: • Plaque psoriasis of the scalp and body in patients 18 years and older • Plaque psoriasis of the scalp in patients 12 to 17 years WARNINGS AND PRECAUTIONS: Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been observed with use of Taclonex® Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Taclonex® Topical Suspension treatment of more than 8 weeks has not been evaluated. Effects on Endocrine System: Taclonex® Topical Suspension can cause reversible hypothalamic-pituitaryadrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of Taclonex® Topical Suspension and Taclonex® Ointment on the HPA axis, 32 adult subjects were treated with both Taclonex® Topical Suspension on the scalp and Taclonex® Ointment on the body. Adrenal suppression was identified in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In another trial of 43 subjects treated with Taclonex® Topical Suspension on body (including the scalp in 36 out of 43 subjects) adrenal suppression was identified in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects who continued treatment for 8 weeks. In a trial evaluating the effects of Taclonex® Topical Suspension on the HPA axis, 31 subjects aged 12 to 17 years were treated with Taclonex® Topical Suspension on the scalp. Adrenal suppression was identified in 1 of 30 evaluable subjects (3.3%) after 4 weeks of treatment. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Cushing’s syndrome and hyperglycemia may also occur due to the systemic effects of the topical corticosteroid. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Allergic Contact Dermatitis with Topical Corticosteroids: Allergic contact dermatitis to a topical corticosteroid is usually diagnosed by observing a failure to heal rather than a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. Allergic Contact Dermatitis with Topical Calcipotriene: Allergic contact dermatitis has been observed with use of topical calcipotriene. Such an observation should be corroborated with appropriate diagnostic patch testing. Eye Irritation: Avoid eye exposures. Taclonex® Topical Suspension may cause eye irritation. Risks of Ultraviolet Light Exposures: Patients who apply Taclonex® Topical Suspension to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. Physicians may wish to limit or avoid use of phototherapy in patients who use Taclonex® Topical Suspension. CONTRAINDICATIONS: None. ADVERSE REACTIONS: 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 directed compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Conducted in Subjects 18 years and older with Scalp Psoriasis: The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in adult subjects with scalp psoriasis. Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 g. Adverse reactions that occurred in ≥1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1: Table 1 Number and Percentage with Adverse Reactions in Scalp Psoriasis Trials (Events Reported by ≥1% of Subjects and for Which a Relationship is Possible) Betamethasone Calcipotriene Vehicle Taclonex® Topical dipropionate in vehicle in vehicle Suspension N=1,953 N=1,214 N=979 N=173 # of subjects (%) Event Folliculitis 16 (1%) 12 (1%) 5 (1%) 0 (0%) Burning sensation of skin 13 (1%) 10 (1%) 29 (3%) 0 (0%) Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash. In a 52-week trial, adverse reactions that were reported by >1% of subjects treated with Taclonex® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). Clinical Trials Conducted in Subjects 18 years and older with Psoriasis on the Body: In randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in adult subjects with plaque psoriasis on non-scalp areas, subjects applied study product once daily for 8 weeks. A total of 824 subjects were treated with Taclonex® Topical Suspension and the median weekly dose was 22.6 g. There were no adverse reactions that occurred in ≥1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle. Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: rash and folliculitis. Clinical Trials Conducted in Subjects 12 to 17 years with Scalp Psoriasis: In two uncontrolled prospective clinical trials, a total of 109 subjects aged 12-17 years with plaque psoriasis of the scalp were treated with Taclonex® Topical Suspension once daily for up to 8 weeks. The median weekly dose black was 40 g. Adverse reactions included acne, acneiform dermatitis and application site pruritus (0.9% each). USE IN SPECIFIC POPULATIONS: Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with Taclonex® Topical Suspension. Taclonex® Topical Suspension contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. There are no adequate and well-controlled studies in pregnant women. Taclonex® Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Nursing Mothers: Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing. Pediatric use: Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients under the age of 12 years have not been established. The safety and effectiveness of Taclonex® Topical Suspension for the treatment of plaque psoriasis of the scalp have been established in the age group 12 to 17 years. Two prospective, uncontrolled trials (N=109) were conducted in pediatric subjects age 12 to 17 years with scalp psoriasis, including assessment of HPA axis suppression in 30 subjects. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids. Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. Geriatric use: Clinical studies of Taclonex® Topical Suspension in plaque psoriasis on non-scalp areas included 124 subjects who were 65 years of age or over, and 36 were 75 years of age or over. Clinical studies of Taclonex® Topical Suspension in scalp psoriasis included 334 subjects who were 65 years or over and 84 subjects who were 75 years or over. No overall differences in safety or effectiveness of Taclonex® Topical Suspension were observed between these subjects and younger subjects, and other reported clinical experience has not identified any differences in response between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. DOSAGE AND ADMINISTRATION: Instruct patients to shake bottle prior to using Taclonex® Topical Suspension and to wash their hands after applying the product. Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. Taclonex® Topical Suspension should not be used with occlusive dressings unless directed by a physician. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. NONCLINICAL TOXICOLOGY: Calcipotriene may enhance the effect of UVR to induce skin tumors. Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. PATIENT COUNSELING INFORMATION: See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: • Instruct adult patients (18 years and older) not to use more than 100 g per week. • Instruct pediatric patients (12 to 17 years) not to use more than 60 g per week. • Discontinue therapy when control is achieved unless directed otherwise by the physician. • Do not apply Taclonex® Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to the hair. Since hair treatments may involve strong chemicals, talk with physician first. • If applied to the scalp, do not wash hair or take a bath or shower right after application. • Avoid use of Taclonex® Topical Suspension on the face, underarms, groin or eyes. If this medicine gets on face or in eyes, wash area right away. • Do not occlude the treatment area with a bandage or other covering unless directed by the physician. • Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. • Wash hands after application. • Instruct patients not to use other products containing calcipotriene or a corticosteroid with Taclonex® Topical Suspension without first talking to the physician. • Instruct patients who use Taclonex® Topical Suspension to avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). MANUFACTURED BY: LEO Laboratories Ltd. (LEO Pharma) 285 Cashel Road Dublin 12, Ireland DISTRIBUTED BY: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054, USA LEO, the LEO Lion Design, and Taclonex are registered trademarks of LEO Pharma A/S. Copyright 2014 LEO Pharma Inc. TSBR-002 November 2014 Printed in USA ES555301_DT0215_024_FP.pgs 01.17.2015 00:13 ADV FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM COSMETIC DERMATOLOGY 25 Experts’ top laser device picks LISETTE HILTON | STAFF CORRESPONDENT Dermatologists with established laser practices agree on their picks for the best workhorse lasers. These are the lasers, dermatologists say, they use day after day, regardless of where they practice in the United States. PULSED DYE, NONABLATIVE FRACTIONATED Tina S. Alster, M.D., who started the Washington Institute of Dermatologic Laser Surgery in 1990, says there are a few devices she can’t live without at her Washington, D.C., laser practice. “One is t he pulsed dye laser, which is a vascular-specific laser that I use for birthmarks, port wine s t a i n s , h e m a nDr. Alster g i o m a s , h y p e rtrophic scars (and) for a variety of other vascular conditions,” she says. “It is a workhorse laser for me. It also happens to be my oldest laser. Of course, the system has received several upgrades over the years, but it’s the laser system that is my longest-standing and most used.” Dr. Alster’s second pick is her nonablative fractionated laser, the Fraxel Dual (Solta Medical). “I like it because you can treat atrophic acne and traumatic or surgical scars, as well as wrinkles, dyspigmentation, large pores and stretch marks. Unlike prior resurfacing lasers, it is useful for treatment of photodamaged and scarred skin in nonfacial areas, as well,” she says. She could start a new laser practice with the pulsed dye and nonablative fractionated devices, alone, she says, along with fillers and injectables. Terrence Keaney, M.D., clinical professor of dermatology and urology at George Washington University Medical Center, and director of the Men’s Cosmetic Center at the Dr. Keaney Washington Insti- magenta cyan yellow black QUICK READ Experts point to their top selections of laser and light devices that they use daily for treating a variety of conditions. tute of Dermatologic Laser Surgery, says the two most popular lasers for his male patients are the pulsed dye and nonablative fractionated resurfacing lasers. “There are a lot of men coming in for the treatment of rosacea, which is common in men, as well as a lot of male patients coming in for treatment of acne scarring or traumatic scarring,” Dr. Keaney says. “I found that both of those lasers can be used for scarring. The pulsed dye laser is indicated for hypertrophic, erythematous traumatic scars; whereas the fractionated nonablative resurfacing laser is great for atrophic acne scarring or older atrophic scars.” Elizabeth L. Tanzi, M.D., clinical professor of dermatology at George Washington Univ er s it y Me d ic a l Center, also a co-director at the Washington Institute of Dermatologic Laser Surger y, says the Dr. Tanzi two things she does most often at her laser practice happen to be the procedures she enjoys the most. The first is the treatment of scars with pulsed dye or fractionated lasers. “I love to treat scars because of the high level of satisfaction, not only for the patient but also for the physician. The laser treatment of scars has really blossomed in the past two decades,” Dr. Tanzi says. Another top pick for Dr. Tanzi is fractionated lasers because of their versatility. “[Fractionated lasers] treat scars well, but they can also treat other indications, such as photodamaged skin, wrinkles, and they treat old acne scars. So, fractional lasers are high on the list as one of the first lasers in which to invest if you’re thinking about starting a laser practice,” she says. INTENSE PULSED LIGHT Michael H. Gold, M.D., whose laser practice in Nashville, Tenn., features more than 40 devices, says the workhorse in any laser practice is Intense pulsed light (IPL) or the Harmony AFT (Advanced Fluorescence Technology, Alma Lasers), which is needed for treating red and brown lesions. “It is a must for pigment and vascular lesions and rejuvenating the skin. The AFT 540 and 570 nm with contact cooling is a technology we use every day,” Dr. Gold says. “IPLs of today are far more sophisticated than IPLs of yesterday — better in ever y way. Dev ices like t he Harmony, the M22 (Lumenis), and the BBL (BroadBand Light; Sciton) are used all the time a nd we f ind paDr. Gold tients requesting these kinds of treatments daily.” IPL is a proven technolog y and works to rejuvenate the skin, according to Dr. Gold. “Fractional lasers can be used to rejuvenate the skin and also to treat acne scars. One can also use fractional bipolar RF in these cases that has proven to work very nicely here,” he says. OTHER GO-TO DEVICES Photodynamic therapy for acne is among the sound device options for dermatologists who don’t do cosmetic work, according to Bruce Katz, M.D., director of the Juva Skin and Laser Center in midtown Manhattan, N.Y. “Today we have lasers that will treat psoriasis, vitiligo — we have lasers just for medical conditions. These include 308 nm lasers,” Dr. Katz says. Dr. Katz, who has more than 50 lasers at his laser practice, says his go-to devices include a fractional laser for wrinkles, the alexandrite laser for brown spots, a pulsed dye laser for broken blood vessels and redness, and a radiofrequency type device for skintightening. “There’s a new one that is called vShape (Alma Lasers), which we use for skin tightening. That’s good for… around the neck, jowls (and for) loose abdoDEVICES see page 26 ES556489_DT0215_025.pgs 01.21.2015 01:33 ADV 26 COSMETIC DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM DEVICES: Experts discuss their top choices for laser devices from page 25 mens.” Dr. Katz says. “If you want to do liposuction… then I would say laser lipolysis, called Smartlipo (Cynosure). Cellulite is a very popular problem, so a laser to treat that is called Cellulaze (Cynosure).” If she were to add a third dimension, Dr. Alster says she most likely would have body contouring devices, including Coolsculpting and Ultherapy (Ulthera), an ultrasound device for skin lifting and tightening. A hair removal dev ice is one to consider, accord i ng to Dr. Kat z. He also points out that the hair removal laser you choose depends on your patient population’s skin type — whether you have patients with lighter or darker skin. Depending on where a practice is, tattoo removal could be a lucrative addition to a dermatologist’s menu of services. Estimates are that nearly 10 percent of Americans have some sort of tattoo, and as many as half of those will eventually want them removed. One laser that’s creating a buzz for tattoo removal is the PicoSure (Cynosure), according to Dr. Katz. The laser delivers ultra-short pulse bursts of energy to the skin in trillionths of a second and the device’s pulse width is 100 times shorter than nanosecond technology. These features, according to company literature, result in better clearance with fewer treatments and less fluence. APPROACH WITH CAUTION Some skin issues are better left to treatments outside the realm of lasers and light sources, and melasma is a prime example Dr. Tanzi says. “Oftentimes, laser treatments are not effective for melasma or may even worsen it due to the heat imparted by the laser. Chemical peels are just as effective if not better than laser for melasma,” she says. “If you’re talking about things like psoriasis, lasers can be helpful... in small areas, but if a patient has widespread psoriasis, lasers will only have a supportive role.” It’s also important that dermatologists use the best laser for any given indication, rather than use a subpar technology when other better options exist. DT Disclosures: Dr. Tanzi is on the medical advisory boards at Zeltiq, Marimar and Clarisonic. Dr. Alster has relevant financial interests with Cynosure, Home Skinovations, Palomar and Syneron. Dr. Katz is on the clinical advisory boards of Allergan, Alma, Valeant and Merz. He is a consultant for Pacific Biosciences and El-En Engineering, and is a Cynosure stockholder. Dr. Gold is compensated for research initiatives and speaking engagements when sponsored by laser companies. He works with Alma, Lumenia, Syneron, Ellman, Ulthera and Venus. Dr. Keaney reports no relevant financial interests. SOCIAL INFLUENCE: Online communities infuence cosmetic surgery decisions from page 22 a rating of one star for factors such as no insurance coverage, length of time in the waiting room or something else not related to your expertise or the actual clinical results achieved. “Patients can easily try and ruin your reputation with online media, such as Yelp or RealSelf,” says Dr. Emer. For social media posts that you cannot control, such as patient tweets or posts on a physician review site, including RealSelf, Dr. Emer suggests an excessively positive approach. “Flood out the bad with the good. Influence good reviews by having happy patients give important testimonials. Not just that they are happy, but why. What was done that was different? How did the person, practice or procedure stand out?” he advises. RealSelf research also suggests that actively engaging in information sharing online can positively inf luence physician reviews. “Our data reveals that a doctor’s online performance rating is directly proportional to their level of activity in posting expert insights and engagement of patients in sharing their reviews and testimonials,” explains Seery. “Doctors may be reluctant to magenta cyan yellow black give away their hard-earned expertise for free online, but content is the future of marketing and acquiring patients from the web.” Just as with any other professional recommendation or business tips on how to run a better healthcare practice, some clinicians will embrace the concept, while others take a more cautious approach. Because social media offers fingertip access to information and critiques to anyone, Dr. Emer finds that web surfers sometimes attempt to gain cosmetic surgery services when they have little or no access to pay. Such patient contact can be a drain and a strain on office staff, unless you establish some ground rules for staff members to follow. “Uninterested patients will contact you for pro bono cases or to waste staff time,” he explains. “It is important to have good initial contact protocols and measures to ensure that your time is well spent when floods of calls come in from social media or online.” Overall, Dr. Emer is a believer. But he’s also taken the time to invest in his online engagement with patients. “I have used RealSelf for the past two years for patient acquisition and for personal interest,” he explains. “I started a blog... about what doctors can learn from RealSelf and why it is important for practices to be involved in using it.” His blog is called Cosmetic Complications and available on the Cosmetic Surgery Times website. He also advertises on RealSelf via local doctor “spotlights” or as an expert in a specific procedure. “I post videos of almost all of my procedures and results, as well as me teaching cutting-edge procedures and technologies to other doctors and residents,” he says. “Often I’m showing devices before they come out.” Although Dr. Emer has faced criticism for the content of some of his postings, he defends his choices as a business decision. “I get a lot of slack when I post pictures of me doing buttock augmentation, fat transfer and liposuction. The same goes for posts I have done on vaginal skin tightening, anal hair removal, Botox for scrotal sweating or filler for nipple projection. “Listen, patients ask for it! If you don’t talk about it and put it out there, someone else will and beat you to it.” DT ES557077_DT0215_026.pgs 01.22.2015 01:03 ADV 28 COSMETIC DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Hair versus health in African American women JOHN JESITUS | STAFF CORRESPONDENT A dichotomy exists between some hair care concerns of African-American patients and their overall health, a recent survey indicates. In the survey of 200 African-American women, 45 percent reported avoiding exercise at some point in the past due to hair care concerns, says study co-author Raechele Cochran Gathers, M.D., senior staff member in the Henry Ford Health System Department of Dermatology’s Multicultural Dermatology Center. “Much more troubling is that 22 percent of these women felt that their hair itself prevented them from maintaining a healthy weight,1 ” Dr. Gathers says. “According to the Centers for Disease Control and Prevention, 50 percent of black women over age 20 are overweight or obese. This compares with 33 percent of white women and 43 percent of Hispanic women.”” In the study, 59 percent of AfricanAmerican women reported a history of “excessive hair loss.” In dermatology, Dr. Gather adds, alopecia is the fourth most common presenting complaint of African-Americans. The impact of hair loss on quality of life has been shown to rival that of severe psoriasis.2 Also in this study, 40 percent of respondents expressed dissatisfaction with the way their current physician had managed their hair loss. Along with irregularities in diameter, “African-American hair has the greatest variability of phenotype among all ethnic groups.... You’re likely to see... wavy, curly, kinky, woolly or very tightly coiled, spring-like hair.” African hair has less tensile strength than Asian and Caucasian hair, she says, which may be due to the many twists in the hair that can contribute to simple and complex knots that further undermine tensile strength. In one study, “The ends of African hair tended to be serrated or frayed, indicating a history of breakage.”3 In contrast, she says that the ends of Asian and Caucasian hair generally appeared cleanly cut. Dr. Gathers sees traction alopecia, chemical or traumatic alopecia and magenta cyan yellow black central centrifugal cicatricial alopecia (CCCA) every day. TRACTION ALOPECIA Traction hair loss usually appears in the temporal and parietal areas. Dr. Gathers has also seen it at the frontal and occipital scalp and the vertex. Usually it’s due to prolonged tension from tight braiding or weaving, the use of tight rollers, ponytail extensions and aggressive combing or relaxer application, she says. Sometimes pruritus accompanies alopecia. Initiating some form of treatment regimen is important, because chronicity is associated with permanence, she says. In addition to discontinuing tractioninducing hairstyles, this can be treated with intralesional (once monthly) and topical (once or twice daily) steroids. Doxycycline, then sometimes topical clindamycin, can be used for any pustular component, and off-label minoxidil can be helpful, she says; though, patients who straighten their hair may not comply with a liquid vehicle. CHEMICAL, TRAUMATIC ALOPECIA A common complaint for chemical or traumatic alopecia is that the hair won’t grow. Causes of chemical and traumatic alopecia include relaxers, coloring, heat, traction and dryness. Accordingly, she advises no relaxers for at least six to 12 months. She recommends heat application no more than once weekly, along with gently or finger combing the hair, and gradually cutting damaged hair. She also recommends a weekly shampoo plus a moisturizing conditioner. CCC ALOPECIA CCCA is characterized by a shiny scalp and loss of the follicular openings. It begins on the scalp vertex and extends centrifugally with time. “We believe it’s likely due to traction secondary to braided or weaved hairstyles,” she says. Evidence also suggests that damage from chemical relaxers may play a role, as might a genetic link,4 she adds. Along with stopping the damaging practices, treatment includes a combination of topical and intralesional corticosteroids, the latter typically for a six-month course. As with traction alopecia, “We also use doxycycline and off-label minoxidil.” Catching CCCA early and preventing its progression can be especially gratif ying, she says. Patients may present with itching and tenderness at the crown or the chief complaint that hair won’t grow at the crown, she says. One study suggests that that hair breakage presages CCCA. 5 Another study involving eight African-American women who had engaged in traumatic hair care practices within the previous month but had no evidence of alopecia or scalp inf lammation showed changes consistent with CCCA on scalp biopsies,6 suggesting a possible histologic prelude to our clinical acknowledgment, she says. Finally, an analysis of C nerve fibers found a positive correlation between CCCA severity and peak itch ratings to cowhage, but not to histamine peak itch on the lesional scalp.7 Because cowhage induces itch and inflammation via protease-activated receptor (PAR)-2, Dr. Gathers says, “There may be a role for this receptor in the pathogenesis or treatment of CCCA.” DT Dr. Gathers reports no relevant financial interests. 1. Gathers RC, Mahan MG. African american women, hair care, and health barriers. J Clin Aesthet Dermatol. 2014;7(9):26-9. 2. Williamson D, Gonzalez M, Finlay AY. The effect of hair loss on quality of life. J Eur Acad Dermatol Venereol. 2001;15(2):137-9. 3. Khumalo NP, Doe PT, Dawber RP, Ferguson DJ. What is normal black African hair? A light and scanning electron-microscopic study. J Am Acad Dermatol. 2000;43(5 Pt 1):814-20. 4. Dlova NC, Jordaan FH, Sarig O, Sprecher E. Autosomal dominant inheritance of central centrifugal cicatricial alopecia in black South Africans. J Am Acad Dermatol. 2014;70(4):679-682.e1. 5. Callender VD, Wright DR, Davis EC, Sperling LC. Hair breakage as a presenting sign of early or occult central centrifugal cicatricial alopecia: clinicopathologic findings in 9 patients. Arch Dermatol. 2012;148(9):1047-52. 6. Uhlenhake EE, Mehregan DM. Prospective histologic examinations in patients who practice traumatic hairstyling. Int J Dermatol. 2013;52(12):1506-12. 7. Bin saif GA, Mcmichael A, Kwatra SG, Chan YH, Yosipovitch G. Central centrifugal cicatricial alopecia severity is associated with cowhage-induced itch. Br J Dermatol. 2013;168(2):253-6. ES556604_DT0215_028.pgs 01.21.2015 03:28 ADV ONE TOUGH SPRAY A super-potent spray for moderate to severe plaque psoriasis Patient pictured was not a participant in the Phase 3 clinical studies for Topicort® Topical Spray. Individual results may vary. Photos and notes provided by J. Bikowski, M.D.1 BASELINE LEG AFTER 4 WEEKS OF TREATMENT Erythematous, scaling plaques on anterior left leg. Lesions decreased in thickness and scale. Topicort® Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. Important Safety Information • Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. • Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insuóciency. This may occur during treatment or upon withdrawal of the topical corticosteroid. • Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. • Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local reactions may be irreversible. • Safety and eòectiveness of Topicort® Topical Spray in patients younger than years of age have not been studied therefore use in pediatric patients is not recommended. 1. Data on file, Taro Pharmaceuticals U.S.A., Inc. ® magenta cyan yellow black See brief summary of Prescribing Information on reverse side. © 2014 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. AD100-0036 June 2014 ES542911_DT0115_TARO1_FP.pgs 12.11.2014 15:32 ADV TOPICORT® (desoximetasone) Topical Spray, 0.25% Rx Only BRIEF SUMMARY 1 INDICATIONS AND USAGE Topicort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Efect on Endocrine System Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitaryadrenal (HPA) axis. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insuóciency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identiöed in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort® Topical Spray twice a day for 28 days. [see Clinical Pharmacology (12.2)] Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insuóciency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specifc Populations (8.4)] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be conörmed by patch testing. 5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Topicort® Topical Spray should be discontinued until the infection has been adequately treated. 5.5 Flammable Contents Topicort® Topical Spray is øammable; keep away from heat or øame. 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 reøect the rates observed in practice. In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort® Topical Spray. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic &òects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Topicort® Topical Spray should be used during pregnancy only if the potential beneöt justiöes the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort® Topical Spray based on a body surface area comparison. 8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward eòects. It is not known whether topical administration of corticosteroids could result in suócient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Topicort® Topical Spray is administered to a nursing woman. If used during lactation, Topicort® Topical Spray should not be applied on the chest to avoid accidental ingestion by the infant. 8.4 Pediatric Use Safety and eòectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. 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 and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insuóciency during and or after withdrawal of treatment. Adverse eòects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. [see Warnings and Precautions (5.1)] HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. [see Warnings and Precautions (5.1)] 8.5 Geriatric Use Clinical studies of Topicort® Topical Spray did not include suócient numbers of subjects aged 65 years and over to determine whether they respond diòerently from younger subjects. Other reported clinical experience has not identiöed diòerences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reøecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 10 OVERDOSAGE Topicort® Topical Spray can be absorbed in suócient amounts to produce systemic eòects. [see Warnings and Precautions (5.1)] 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: • Use this medication as directed by the physician. • Topicort® Topical Spray is for external use only. Avoid use on the face, axilla or groin. • Do not use this medication for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive. • Report any signs of local or systemic adverse reactions to the physician. • Do not use other corticosteroid-containing products with Topicort® Topical Spray without örst consulting with the physician. • Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician. • This medication is øammable; avoid heat, øame, or smoking when applying this product. • Discard this product 30 days after dispensed by pharmacist. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: April 2013 AD100-0030 Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%). Another less common adverse reaction (<1% but >0.1%) was folliculitis. Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Topicort® Topical Spray, 0.25% b.i.d. (N = 149) Vehicle spray b.i.d. (N = 135) Number of Subjects with Adverse Reactions 13 (8.7%) 18 (13.3%) Application site dryness 4 (2.7%) 7 (5.2%) Application site irritation 4 (2.7%) 5 (3.7%) Application site pruritus 3 (2.0%) 5 (3.7%) black ES542910_DT0115_TARO2_FP.pgs 12.11.2014 15:32 ADV FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM COSMETIC DERMATOLOGY 31 IN SEARCH OF FINDING AN ANTI-AGING GENE 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 zdraelos@ northstate.net COSMETIC CONUNDRUMS Q: A: What is the Klotho antiaging gene? The human genome project was completed without finding an anti-aging gene, much to the disappointment of scientists. Yet, the search continues for genes that could be modified to influence aging. One such gene that was discovered in mice is known as the Klotho gene, named after the Greek goddess Klotho who controlled the lives and destinies of humans. This gene has not been found in humans, but appears to be overexpressed in mice that have an extended lifespan. This gene codes for many things including a transmembrane protein inhibiting phosphorylation of insulin-like growth factor 1. The inhibition of insulin binding mimics caloric restriction, which is the only alteration in behavior that has ever been shown to consistently prolong lifespan in mice. It is hoped that further study into the gene may result in findings that are applicable to humans. magenta cyan yellow black Q: A: What is snow algae? Snow algae is an interesting single cell algae that survives at 0 degrees C. It accounts for the red snow seen in many polar climates because during the dormant winter months the algae produces red spores that are rich in carotenoid pigments for UV protection. During the spring and summer growing season, the algae turns green manufacturing chlorophyll for energy producing photosynthesis. The algae is becoming a popular cosmetic ingredient because it can be grown in indoor bioreactors providing a botanical extract free of pesticides and other environmental contaminants. Further, one manufacturer claims that snow algae is the missing link between insulin-like growth factor 1 and skin physiology. The value of genetically customized skincare products remains questionable. Q: A: What are genetically customized skincare products? One of the currently popular fads in high end boutique skincare products is the development of genetically customized formulations. These formulations are said to be constructed specifically for individual purchasers skin and health needs working with their genetic composition to offer superior benefits. How exactly is this customization accomplished? The purchaser is instructed to swab their buccal mucosa with a flat wooden spatula several times and place the scrapings into a jar filled with a transport media. Both the specimen and a questionnaire are sent to the company for analysis. This type of genetically customized skincare has recently come under scrutiny from the US FTC who is concerned that these companies are misleading consumers via fraudulent claims. Indeed, it is possible that the manufacturer is using the questionnaire information regarding dry vs. oily skin, sun exposure, skin color, etc., to select skincare products and not the genetic information obtained from the buccal swab. Thus, the value of genetically customized skincare products remains questionable. Q: Can the fluoride in toothpaste cause acne around the mouth or perioral dermatitis? Fluoride is found in many toothA: pastes designed to prevent tooth decay. Brushing with a fluoride-ion containing solution can increase the amount of fluoride ions present in the tooth apatite lattice. As the fluoride is deposited in the tooth, it creates a stronger crystalline lattice and makes the tooth more acid resistant. With this brief background in fluoride containing toothpastes, I am not aware of any scientifically proven connection between toothpaste fluoride and acne or perioral dermatitis. That said, the toothpaste should be kept in the mouth and not spread on the face and rinsed thoroughly from the mouth following brushing. DT ES557171_DT0215_031.pgs 01.22.2015 01:16 ADV 32 CUTANEOUS ONCOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM ACCELERATES DRUG APPROVAL 36 FDA Nivolumab (Opdivo, Bristol-Myers Squibb) approved for the treatment of unresectable or metastatic melanoma BETTER AT MELANOMA DX 41 DERMS Non-dermatologists would benefit from more training in pigmented lesion diagnosis Cutaneous T-cell lymphoma: Poised for a new treatment paradigm CAROLINE HELWICK | STAFF CORRESPONDENT Cutaneous T-cell lymphoma (CTCL) lags behind others in terms of targeted treatment advances, but with better understanding of its molecular signaling pathways and the immune microenvironment, it could soon catch up, according to experts who presented at the 3rd Annual World Cutaneous Malignancies Congress (2014, San Francisco, Calif.). CURRENT OPTIONS, UNANSWERED QUESTIONS “The hope in the CTCL field is that we are approaching an entry door of drug development based on advances in basic science research,” Pierluigi Porcu, M.D., associate professor of medicine at The Ohio State University, Columbus, Ohio, told attendees. But in addition to the need for drug development, Dr. Porcu suggests that there are several fundamental issues that should be clarified, including one pertaining to staging with the tumornode-metastasis-blood (TNMB) system. “We have a single tool to assess and describe different things: mapping of sites of involvement, prognostic risk assessment at diagnosis, quantitative measurement of disease, and linking mycosis fungoides (MF) and Sézary syndrome (SS) as a stage transition of the same disease. Relatedness on a molecular level suggests that gene expression profiling overlaps, but the current staging system universally presents the evolution as fixed, and that is not true.” QUICK READ Researchers are aiming to better understand the molecular signaling pathways and the immune microenvironment of cutaneous T-cell lymphoma. The use of targeted or mechanism-based therapies may lead to betterunderstood combinations, higher response rates and better survival. For example, while stage IB patients are considered to have early-stage disease, at 30 years their rate of stage progression is high. “We have a convoluted stage classification system,” he maintains. More needs to be learned about the risk of stage progression in MF/SS and the effect of treatment on this risk, the prognostic factors beyond TNMB stage, the optimal way to describe the involvement of multiple sites, the treatment of large cell transformation, and the best time to initiate systemic therapy. NCCN guidelines recommend both skin-directed and systemic treatments for stage IB, IIA, and IIB disease. Among the available systemic agents are romidepsin and vorinostat (histone deacetylase [HDAC] inhibitors), denileukin diftitox (a fusion protein), and bexarotene (a retinoid receptor activator). Pralatrexate (an antifolate), which is approved in peripheral T-cell lymphoma, and alemtuzumab (an IgG1 antibody), are used off label. Brentuximab vedotin (an antibody-drug conjugate) is expected to become FDA-approved. For patients with good performance status who progress on systemic therapies, allogeneic stem cell transplant can be beneficial. “The overall management of CTCL across stages is complex (Chart: Pierluigi Porcu, M.D.). There is no unified standard of care or universal algorithm,” Dr. Porcu notes. “And since different stages require different types of care, multidisciplinary management is important. All patients with advanced stage disease also have skin lesions remaining in the early stage, and dermatologists should be involved in treating these lesions.” NEW SYSTEMIC THERAPIES: BEYOND THE OLD PARADIGM The conventional treatment paradigm for CTCL has not changed much, but investigational agents are encouraging and are being evaluated in a more evidencebased way, according to Steven M. Horwitz, M.D., associate attending on the Lymphoma Service at Memorial Sloan Kettering Cancer Center, New York. “We are still giving mild systemic therapies sequentially, but we are getting better quality data now. We are beginning to look at progression-free and overall survival,” he says. The established treatment paradigm is exemplified by an underpowered trial from the 1980s, which showed that aggressive initial treatment was no better and more toxic than a conservative, sequential approach using skin-directed therapy and single-agents.[1] “We still use this paradigm,” notes Dr. Horowitz. Newer drugs became approved based on phase 2 studies, but “the CTCL see page 35 DTExtra The newly minted Sunscreen Innovation Act cuts through regulatory red tape that has denied U.S. consumers access to state-of-the-art sunscreens that have long been available in other countries. If it works as planned, the SIA will speed up the FDA’s plodding review process for sunscreen ingredients that have been used in Canada, Europe, and elsewhere for years. READ MORE: BIT.LY/SUNSCREENINGREDIENTLAW magenta cyan yellow black ES557186_DT0215_032.pgs 01.22.2015 01:28 ADV VALCHLOR® (mechlorethamine) gel is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides–type cutaneous T-cell lymphoma (MF-CTCL) in patients who have received prior skin-directed therapy WHEN IT’S TIME TO MANAGE THE CHALLENGES OF STAGE IA AND IB MF-CTCL VALCHLOR IS ON IT The first and only FDA-approved topical formulation of mechlorethamine (commonly known as nitrogen mustard) • Proven effcacy in a 12-month study 1 • Once-daily gel (special handling and disposal procedures should be followed) • Dependable formulation manufactured with consistent quality and potency • Comprehensive resources provided by VALCHLOR Support ™ For more information, including how to prescribe, visit www.valchlor.com or call 1-855-4-VALCHLOR (1-855-482-5245). DOSING AND APPLICATION VALCHLOR is for topical dermatologic use only. Apply a thin flm of gel once daily to affected areas of the skin. VALCHLOR is a cytotoxic drug and special handling and disposal procedures should be followed during use. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Patients and caregivers must wash hands thoroughly after handling or applying VALCHLOR. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. WARNINGS AND PRECAUTIONS • Mucosal or eye injury: Exposure of mucous membranes to mechlorethamine such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Exposure of the eyes causes pain, burns, infammation, photophobia, and blurred vision. Blindness and severe irreversible anterior eye injury may occur. Should eye exposure or mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation • Secondary exposure: Avoid direct skin contact with VALCHLOR in individuals other than the patients due to risk of dermatitis, mucosal injury, and secondary cancers • Dermatitis: Dermatitis may be moderately severe or severe. Monitor patients for redness, swelling, infammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment with VALCHLOR or reduce dose frequency • Non-melanoma skin cancer: Monitor patients during and after treatment with VALCHLOR • Embryo-fetal toxicity: Women should avoid becoming pregnant while using VALCHLOR due to the potential hazard to the fetus. For nursing mothers, discontinue use of VALCHLOR or nursing • Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fre, fame, and smoking until the gel has dried ADVERSE REACTIONS The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and skin hyperpigmentation (5%). These reactions may be moderately severe or severe. Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension, or discontinuation may be required. To report SUSPECTED ADVERSE REACTIONS, contact Actelion Pharmaceuticals US, Inc., at 1-855-4-VALCHLOR (1-855-482-5245) or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Please see Brief Summary of Prescribing Information on adjacent page. REFERENCE: 1. VALCHLOR [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; 2013. VALCHLOR®and VALCHLOR Support™ are trademarks of Actelion Pharmaceuticals Ltd. © 2014 Actelion Pharmaceuticals US, Inc. All rights reserved. VAL-00130 0814 magenta cyan yellow black A great idea finally gels ES555298_DT0215_033_FP.pgs 01.17.2015 00:13 ADV VALCHLOR® (mechlorethamine) gel, 0.016% For Topical Dermatological Use Only Table 1. Most Commonly Reported (≥5%) Cutaneous Adverse Reactions VALCHLOR N=128 % of patients ModeratelyAny Grade Severe or Severe BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION This brief summary does not include all the information needed to use VALCHLOR safely and effectively. See Full Prescribing Information for VALCHLOR. • INDICATIONS AND USAGE VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. • CONTRAINDICATIONS The use of VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. • WARNINGS AND PRECAUTIONS >> Mucosal or Eye Injury Exposure of the eyes to mechlorethamine causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible anterior eye injury may occur. Advise patients that if eye exposure occurs, (1) immediately irrigate for at least 15 minutes with copious amounts of water, normal saline, or a balanced salt ophthalmic irrigating solution and (2) obtain immediate medical care (including ophthalmologic consultation). Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Should mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation. >> Secondary Exposure to VALCHLOR Avoid direct skin contact with VALCHLOR in individuals other than the patient. Risks of secondary exposure include dermatitis, mucosal injury, and secondary cancers. Follow recommended application instructions to prevent secondary exposure. >> Dermatitis The most common adverse reaction was dermatitis, which occurred in 56% of the patients. Dermatitis was moderately severe or severe in 23% of patients. Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. The face, genitalia, anus, and intertriginous skin are at increased risk of dermatitis. Follow dose modification instructions for dermatitis. >> Non-Melanoma Skin Cancer Four percent (4%, 11/255) of patients developed a non-melanoma skin cancer during the clinical trial or during one year of post-treatment follow-up: 2% (3/128) of patients receiving VALCHLOR and 6% (8/127) of patients receiving the mechlorethamine ointment comparator. Some of these non-melanoma skin cancers occurred in patients who had received prior therapies known to cause nonmelanoma skin cancer. Monitor patients for non-melanoma skin cancers during and after treatment with VALCHLOR. Non-melanoma skin cancer may occur on any area of the skin, including untreated areas. >> Embryo-fetal Toxicity Based on its mechanism of action, case reports in humans, and findings in animals, VALCHLOR can cause fetal harm when administered to a pregnant woman. There are case reports of children born with malformations in pregnant women systemically administered mechlorethamine. Mechlorethamine was teratogenic and embryo-lethal after a single subcutaneous administration to animals. Advise women to avoid becoming pregnant while using VALCHLOR. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. >> Flammable Gel Alcohol-based products, including VALCHLOR, are flammable. Follow recommended application instructions. • ADVERSE REACTIONS In a randomized, observer-blinded, controlled trial, VALCHLOR 0.016% (equivalent to 0.02% mechlorethamine HCl) was compared to an Aquaphor®-based mechlorethamine HCl 0.02% ointment (Comparator). The maximum duration of treatment was 12 months. Sixty-three percent (63%) of patients in the VALCHLOR arm and 67% in the comparator arm completed 12 months of treatment. Comparator N=127 % of patients ModeratelyAny Grade Severe or Severe Dermatitis 56 23 58 17 Pruritus Bacterial skin infection Skin ulceration or blistering Skin hyperpigmentation 20 11 6 5 4 2 3 0 16 9 5 7 2 2 2 0 In the clinical trial, moderately-severe to severe skin-related adverse events were managed with treatment reduction, suspension, or discontinuation. Discontinuations due to adverse reactions occurred in 22% of patients treated with VALCHLOR and 18% of patients treated with the comparator. Sixty-seven percent (67%) of the discontinuations for adverse reactions occurred within the first 90 days of treatment. Temporary treatment suspension occurred in 34% of patients treated with VALCHLOR and 20% of patients treated with the comparator. Reductions in dosing frequency occurred in 23% of patients treated with VALCHLOR and 12% of patients treated with the comparator. Reductions in hemoglobin, neutrophil count, or platelet count occurred in 13% of patients treated with VALCHLOR and 17% treated with Comparator. • DRUG INTERACTIONS No drug interaction studies have been performed with VALCHLOR. Systemic exposure has not been observed with topical administration of VALCHLOR; therefore, systemic drug interactions are not likely. • USE IN SPECIFIC POPULATIONS >> Pregnancy Pregnancy Category D Risk Summary Mechlorethamine can cause fetal harm when administered to a pregnant woman. There are case reports of children born with malformations to pregnant women systemically administered mechlorethamine. Mechlorethamine was teratogenic in animals after a single subcutaneous administration. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Animal Data Mechlorethamine caused fetal malformations in the rat and ferret when given as single subcutaneous injections of 1 mg/kg. Other findings in animals included embryolethality and growth retardation when administered as a single subcutaneous injection. >> Nursing Mothers It is not known if mechlorethamine is excreted in human milk. Due to the potential for topical or systemic exposure to VALCHLOR through exposure to the mother’s skin, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. >> Pediatric Use Safety and effectiveness in pediatric patients have not been established. >> Geriatric Use A total of 79 patients age 65 and older (31% of the clinical trial population) were treated with either VALCHLOR or the comparator in the clinical trial. Forty-four percent (44%) of patients age 65 or older treated with VALCHLOR achieved a Composite Assessment of Index Lesion Severity (CAILS) response compared to 66% of patients below the age of 65. Seventy percent (70%) of patients age 65 and older experienced cutaneous adverse reactions and 38% discontinued treatment due to adverse reactions, compared to 58% and 14% in patients below the age of 65, respectively. Similar differences in discontinuation rates between age subgroups were observed in the comparator group. Manufactured for: Actelion Pharmaceuticals US, Inc. South San Francisco, CA 94080, USA © 2014 Actelion Pharmaceuticals US, Inc. All rights reserved. The body system associated with the most frequent adverse reactions was skin and subcutaneous tissue disorders. The most common adverse reactions (occurring in at least 5% of the patients) are shown in Table 1. VAL-00133 0814 black ES555372_DT0215_034_FP.pgs 01.17.2015 01:24 ADV CUTANEOUS ONCOLOGY FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM 35 CTCL: Better understanding may lead to more effective therapies from page 32 bar was pretty low. Basically, a drug with activity and relative safety could get approved, without much data on survival or quality of life.” RAISING THE BAR Recently, the bar for drug approval in CTCL has been raised, and randomized studies are comparing investigational agents to standard therapies. One phase 3 trial is comparing the brentuximab vedotin (Adcetris, Seattle Genetics) (an anti-CD30 antibody plus monomethyl auristatin E) to methotrexate or bexarotene (Targretin, Valeant) in patients with relapsed CD30+ MF. In early studies, very high response rates have been observed, approximately 70% across the spectrum of CD30 expression.[2] Another phase 3 trial is comparing the anti-CCR4 antibody mogamulizumab (Poteligeo, Kyowa Hakko Kirin) to the HDAC inhibitor vorinostat (Zolinza, Merck), with progression-free survival as an endpoint. The CCR4 receptor is present in all stages of CTCL, and levels of expression levels increase with stage of disease. Mogamulizumab is engineered to have potent antibody-dependent cellular cytotoxicity activity and is reasonably well tolerated. In a recent study, 35% of CTCL patients responded, 14% being complete responses.[3] POTENTIAL EFFICACY OF SELECTIVE HDAC INHIBITION Anjali Mishra, Ph.D., assistant professor of dermatology at The Ohio State University Comprehensive Cancer Center, shared new insights about the pathogenesis of CTCL, focusing on interleukin (IL)15. She observes that IL-15 is overexpressed in patients with CTCL, and IL-15 transgenic mice progress to a severe stage of the malignancy. “IL-15 has long been known to stimulate the immune system. What was perplexing is that we found this growth factor to be responsible for cancer,” Dr. Mishra says. Dr. Mishra and her colleagues showed that the IL-15 promotor gene causes its upregulation and signaling during oncogenic transformation, which contradicts the central dogma that methylation switches off a gene. “We found that T-cells had acquired epigenetic abnormalities in the IL-15 promotor that turns magenta cyan yellow black Clinical Management of CTCL – 2014 IB/IIA Generalized patch/plaque IA Limited patch/plaque #1 IIB Tumors III Erythroderma IV Extracutaneous Disease Topical steroid, retinoids, NM, HDACi , UV phototherapy , local RT, imiquimod (off label) #4 #5 ECP + IFN, bexarotene , HDACi Single- agent chemotherapy * #2 Phototherapy + Systemic ( bexarotene , IFN, HDACi ) #8 Looping Back The NCCN guidelines point out that patients who relapse after an initial response often respond well to the same treatment. #6 #7 #3 Alemtuzumab (Sezary ) TSEBT, IFRT Comb. Chemo Comb. Chemo Bexarotene , IFN, HDACi (single or combination) #9 Whenever appropriate Allogeneic HSCT Clinical Trials *Methotrexate, liposomal doxorubicin, gemcitabine, pentostatin, chlorambucil, etoposide, Pralatrexate Modifed from: John Zic et al. The overall management of CTCL across stages is complex. Different stages require different types of care; so multidisciplinary management is important. on IL-15 production. IL-15 goes out of the cell, binds to its own receptor, and causes upregulation of HDAC 1, 2, and 6. We think, therefore, that the right therapeutic approach in CTCL should be to target these HDACs specifically,” she suggests. This occurs with the experimental and topical HDAC inhibitor, SHP-141, which inhibits the HDAC isoforms 1, 2, 3 and 6, according to Dr. Horwitz. He described SHP-141 as a “soft drug” that is active in the skin but then breaks down to an inactive metabolite, avoiding systemic effects. In a study presented at ASCO 2014, the drug was consistently more active than placebo at multiple sites and was well tolerated.[5] SHP-141 is expected to enter phase 2 trials. FUTURE DEVELOPMENTS Targeted agents in development hold the promise of more effective treatment: ➧ More selective HDAC inhibitors ➧ Topical HDAC inhibitors ➧ Kinase inhibitors targeting JAK/STAT, PI3K and ITK/RLK pathways ➧ Immune checkpoint inhibitors: antiPD1, anti-PD-L1/2 ➧ New antibody-drug conjugates Elaborating on these compounds, Dr. Horwitz described IPI-145 as a potent oral inhibitor of the PI3K gamma and delta isoforms that inhibits malignant B-cell and T-cell survival. The drug has interesting activity in T-cell lymphomas, producing response rates around 30% in CTCL and durable responses in some SS patients,[4] he says. Dr. Horwitz also was encouraged to see research on immune checkpoint inhibitors “trickling over into T-cell lymphomas.” This is based on the PD1 and PD-L1 expression observed primarily in SS and to some degree in MF, which down-regulates the antitumor CD8 Tcell response. A multicenter study will evaluate the anti-PD-1 agent pembrolizumab in refractory MF and SS. “We are not really changing the treatment paradigms yet, but we are doing better quality studies. We have several agents that appear reasonably active in CTCL, and they are being compared to standard therapies in randomized studies. In terms of level of evidence, this is a step up, ” Dr. Horwitz says. DT [1] Kaye FJ et al. A randomized trial comparing combination electron-beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. N Engl J Med 1989;321(26):1784-90 [2] Krathen M et al. Brentuximab Vedotin Demonstrates Significant Clinical Activity in Relapsed or Refractory Mycosis Fungoides with Variable CD30 Expression. ASH 2012. Abstract 797 [3] Ogura M. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol 2014;32:1157-63 [4] Horwitz SM et al. Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide3-kinase-δ,γ, in patients with relapsed/refractory lymphoma. ASCO 2013. Abstract 8518 [5] Kim YH et al. A phase 1b study in cutaneous Tcell lymphoma (CTCL) with the novel topically applied skin-restricted histone deacteylase inhibitor (HDAC-i) SHP-141. ASCO 2014. Abstract 8525 ES557185_DT0215_035.pgs 01.22.2015 01:28 ADV 36 CUTANEOUS ONCOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Gigapixel camera has eye for melanoma LISETTE HILTON | STAFF CORRESPONDENT A recently developed gigapixel wholebody photographic camera is like 63 cameras in one, with the potential to image an entire body —down to each mole, freckle and melanoma. Daniel Marks, Ph.D., who helped to develop optics for U.S. military surveillance, created a mega-camera that can take a picture of an entire football stadium, revealing the detail of each fan’s face. Mounted on a drone, the camera can vividly document individual city streets, each car and each person. About three years ago, Dr. Marks, an associate research professor of electrical and computer engineering at Duke University, says a colleague suggested he study the technology for use in dermatology. And he did. “It’s very similar to what’s in the surveillance [technology], but is more portable and photographs a much QUICK READ Whole-body photographic camera developed out of U.S. military surveillance technology may have applications in dermatology. Dermatologists could one day use the camera to take whole-body images in high-risk patients; then, let a computer do the work of analyzing lesions that need attention. smaller object than an entire city,” Dr. Marks says. PROMISING, BUT RESEARCH IS NEEDED Dr. Marks presented the technology and a whole body image of himself at The Optical Society’s annual meeting October 2014 in Tucson, Ariz. The purpose was to showcase the camera’s resolution of features with which dermatologists would be familiar. He and his research team have not yet started, but are planning a pilot study on patients. The goal is to use the camera to find potentially cancerous skin lesions earlier than would be possible with most skin examination techniques. The technology fills a void in skin cancer detection, he says. A dermatologist might examine a small region with a high-resolution, handheld dermatoscope or a large region at low resolution or visually. “To kind of give you an idea what the resolution is, it’s about 75 microns, which is about the width of a human hair. You could potentially see a human hair as one pixel wide on the picture.” Daniel Marks, Ph.D. Duke University Duke University Whole Body Dermascope. This unique instrument simultaneously photographs a 2 meter tall individual to 75 micron resolution. Photo: Daniel Marks, Ph.D./Lauren Bange, Duke University magenta cyan yellow black The gigapixel image doesn’t require a compromise bet ween the two, he says. Using t his camera, dermatologists would photograph whole-body images in detail much greater than what is possible with digital photography mole mapping or the human eye. The images, however, would not be as vivid as a dermatoscope’s 10fold magnification of an individual lesion. “To kind of give you an idea what the resolution is, it’s about 75 microns, which is about the width of a human hair. You could potentially see a human hair as one pixel wide on the picture,” he says. CAMERA see page 38 ES556475_DT0215_036.pgs 01.21.2015 01:33 ADV magenta cyan yellow black ES555389_DT0215_037_FP.pgs 01.17.2015 01:25 ADV 38 CUTANEOUS ONCOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM FDA accelerates approval of melanoma drug BILL GILLETTE | STAFF CORRESPONDENT The Food and Drug Administration has granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of unresectable or metastatic melanoma and for patients whose disease has progressed following ipilimumab and, if BRAF V600 mutationpositive, a BRAF inhibitor. According to the FDA, approval was based on objective response rate (ORR) and durability of response in the first 120 patients who were treated with nivolumab and had a minimum sixmonths follow-up as part of a trial in which 370 patients with unresectable or metastatic melanoma received nivolumab intravenously every two weeks or investigator’s choice of chemotherapy, which included either dacarbazine or the combination of carboplatin plus paclitaxel. Patients with unresectable or metastatic melanoma were required to have disease progression following ipilimumab, and a BRAF inhibitor if BRAF V600 mutation-positive. Patients with either an autoimmune disease, a medical condition that required corticosteroids or immunosuppression, or a history of severe ipilimumab-related adverse reactions were excluded from the trial. T he major ef f icac y endpoi nt s were confirmed ORR—assessed by a blinded independent review committee—and response duration. The ORR was 32 percent, with four complete responses and 34 partial responses. Five responding patients have progressed, while the remaining 33 patients have ongoing responses (range 2.6 to 10-plus months). Thirteen patients have ongoing responses of six months or longer. The most common adverse reaction among the 268 patients receiving nivolumab was rash. The most frequent Grade 3 and 4 adverse drug reactions, observed in 2 percent to less than 5 percent with nivolumab, were abdominal pain, hyponatremia, increased aspartate aminotransferase and increased lipase. Clinically significant immunemediated adverse reactions included pneumonitis, colitis, hepatitis, nephritis/renal dysfunction, hypothyroidism and hyperthyroidism. Among those applauding the FDA’s action was the Melanoma Research Alliance (MRA). “The approval . . . is the latest in a string of good news for patients in 2014 and provides yet another weapon in the fight against melanoma,” MRA Chief Science Officer Louise M. Perkins, Ph.D., tells Dermatology Times. “Dermatologists and their patients with aggressive metastatic melanoma now have more effective options available, and the future looks promising that early-stage patients could potentially benefit, as well.” As a condition of the accelerated approval, the FDA requires Bristol-Myers Squibb to conduct multicenter, randomized trials establishing the superiority of nivolumab over standard therapy in adult patients with unresectable or metastatic melanoma to verify and describe the clinical benefit of the drug. DT CAMERA: Military technology could help dermatologists monitor skin cancer patients from page 36 While all this seems promising, its efficacy is currently unproven. Future studies will determine whether the technology helps dermatologists detect skin cancers earlier than possible with what’s available today, as well as how accurately the technology pinpoints worrisome lesions without increasing the rate of false positives. Studies may show, for example, that low-risk patients might not be good candidates for the technology because the potential for a false positive or false negative outweighs the possibility of catching a skin cancer early. POTENTIAL APPLICATIONS Dr. Marks sees applications for highrisk patients, where dermatologists would use the camera for whole-body images; then, let a computer do the work of analyzing lesions that need attention. magenta cyan yellow black “It’s much more likely that a computer would have to look through that quantity of data because to examine an entire megapixel image at that resolution is a very time-consuming process. For example, if you printed it out, it would be like a 20-foot wide poster on the wall,” Dr. Marks says. An important advantage of the technology is that it would provide a complete record of a patient’s skin at a given time, and could be used at intervals to detect the early changes. “Another potential benefit is telemedicine. A lot of places may have high-speed internet connections but are underserved by specialists,” Dr. Marks says. “It makes the process a lot more accessible to more people.” HOW IT’S USED The camera is about the size of a small television set or a large microwave oven. It’s not as easy to use as a handheld device. This camera would be set on a clinical cart with mobile lighting and should be used in rooms that have a backdrop for taking pictures and controlled lighting conditions. NEXT STEP Dr. Marks says he and his team at Duke are building a database of skin cancer biopsy pathology and photographic records. “If we can correlate specific cond it ions w it h ret rospect ive st udies, where if we had seen this in the image we could have known to investigate that earlier, then we can design a study that basically tests for those particular signatures and tells us whether or not we’re actually finding the disease earlier than if done visually,” he says. “We’re trying to push this technology forward as fast as we can so dermatologists can get their hands on it.” DT ES556476_DT0215_038.pgs 01.21.2015 01:33 ADV FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Dermatologists better at detecting melanoma LOUISE GAGNON | STAFF CORRESPONDENT Dermatologists are significantly better at diagnosing melanoma than nondermatologist clinicians, according to a study presented at the 89th annual meeting of the Canadian Dermatology Association (2014, Toronto). Given the incidence of melanoma is rising yearly in Canada in both men and women, that there were 6,000 new cases of melanoma diagnosed in 2013, and that more than 1,000 Canadians died from melanoma in 2013, according to Canadian Cancer Statistics, it’s imperative for physicians to be able to detect melanoma, explained Michal Martinka, a medical student at the University of British Columbia in Vancouver, British Columbia, in an oral presentation here. “It is essential that they (non-dermatologists) be able to discriminate between benign and malignant lesions,” Mr. Martinka told Dermatology Times. “We compared (the ability of) GPs, dermatologists, and other clinicians, who were typically plastic surgeons.” The retrospective review of skin biops y pat holog y requ isit ions w ith a clinical diagnosis of cutaneous mela noma bet ween Ja nuary through July 2013. The reports were culled from Vancouver Coastal Health. Study investigators noted if the diagnosis was “listed”, meaning melanoma was included in a list of potential diagnoses, or “primary”, meaning melanoma was the favored diagnosis. The total of 225 physicians included in the study consisted of 34 dermatologists and 191 non-dermatologists. Of the 191, 144 were family physicians and 21 were plastic surgeons. Other clinicians included internists, general surgeons, ophthalmologists, nurse practitioners, and dentists.” The total number of cases identified was 922. Of those, 235 were excluded from the study because they were specimens undergoing re-excisional biopsies of previously diagnosed melanoma and excisional biopsies of melanoma that had metastasized. magenta cyan yellow black QUICK READ Retrospective research demonstrated a signifcant difference between dermatologists and non-dermatologists in recognizing melanoma, suggesting increased dermatology training for non-dermatologists should be a priority. Of 215 primary melanomas biopsied by dermatologists, 50 were correct clinical diagnoses while 20 of 348 primary melanomas biopsied by nondermatologists were correct clinical diagnoses, yielding a statistically significant difference, p<0.0001. Similarly, 50 of 300 listed melanomas biopsied by dermatologists were correct clinical diagnoses while 20 of 387 listed melanomas biopsied by non-dermatologists were correct clinical diagnoses, yielding again a statistically significant difference, p<0.0001. “It is essential that they (nondermatologists) be able to discriminate between benign and malignant lesions.” Michal Martinka Vancouver, British Columbia Study investigators then drilled down further amongst the non-dermatologist group. They compared correct clinical diagnoses from dermatologists with those from family physicians and correct clinical diagnoses from dermatologists with those from other non-dermatologists. Dermatologists outperformed both family physicians and other non-dermatologists. “Dermatologists are significantly more likely to be correct (in diagnosing melanoma) than non-dermatologists,” Mr. Martinka says. “Dermatol- CUTANEOUS ONCOLOGY 41 ogists are receiving rigorous training in skin lesion identification.” The data underline a need for increased instruction in dermatology for non-dermatologists, he adds. “There is value in providing more training and education to non-dermatologists as it can have a meaningful impact on patient care,” he says. “They play a pivotal role in the overall treatment and care of the patient. “There is a large disparity between how much training they (non-dermatologists) receive and how often skinrelated conditions present to their them,” Mr. Martinka says. “Particularly in family medicine, about one out of every four visits to a family physician is a skin-related complaint.” Yet there is a dearth of education about dermatology at the undergraduate level in Canadian medical schools, according to Mr. Martinka. “Some (medical) schools offer only two or three days of dermatology education in the classroom,” he says. Published research in the United States supports the contention about insufficient education about dermatolog y amongst non-dermatologic clinicians. Forty percent of primary care residents in California who were surveyed reported that they did not feel prepared through their medical school education to respond to dermatologic issues.1 A retrospective chart review in the United States of 271 consecutive dermatologic consultations from primary care teams demonstrated that the primary care team had a correct diagnosis in less than one out of every four cases (23.9 per cent). Consultation with a dermatologist led to a change in or addition to treatment in the balance of cases.2 DT Michal Martinka had no relevant disclosures. 1 Hansra NK, OÕsullivan P, Chen CL, Berger TG. Medical school dermatology curriculum: are we adequately preparing primary care physicians?. J Am Acad Dermatol. 2009;61(1):2329.e1. 2 Davila, Manuel; Christenson, Leslie J; & Sontheimer, Richard D. (2010). Epidemiology and outcomes of dermatology in-patient consultations in a midwestern U.S. university hospital. Dermatology Online Journal, 16(2). Retrieved from: https://escholarship.org/uc/ item/64h8j3kz ES556474_DT0215_041.pgs 01.21.2015 01:33 ADV 42 BUSINESS OF DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM BUSINESS OF SELLING PHI 46 THE Dermatologists should consider performing a Security Risk Assessment TECHNOLOGY FACTOR 48 THE Prevent bad debt and financial risk using tools to help you collect from patients Revving revenues JOHN JESITUS | STAFF CORRESPONDENT Conducting clinical trials and dispensing skincare products represent opportunities in an ever-changing landscape, according to Kenneth Beer, M.D., who spoke at Cosmetic Bootcamp (CBC) (2014, Aspen). For his practice, Dr. Beer told attendees that clinical trials provide an opportunity to collaborate in the development of new drugs and devices. He is a West Palm Beach, Florida-based dermatologist in private practice and a co-founder of CBC, as well as associate clinical professor of dermatology, University of Miami Miller School of Medicine; consulting associate, department of medicine, Duke University; and clinical associate in dermatology, University of Pennsylvania Perelman School of Medicine. Clinical trials also can provide a great opportunity for patients to get treatments before they are in the mainstream, he says. And if a practice provides satisfactory treatment for patients recruited for an acne or atopic dermatitis study, Dr. Beer says, these patients QUICK READ Performing clinical trials and dispensing in-offce products can help dermatologists diversify their practices and add revenue without necessarily adding patients, says an expert. likely will choose to stay with the practice after the study concludes. COURTING CLINICAL TRIALS In setting up a clinical-trials program, it helps to have an interest in and affinity for this type of work, he says. In his case, “I love to publish, travel and work with drug companies on next-generation products.” Ideally, he says, a practice’s clinicalstudy business should have a separate location, corporate structure and staff. Alternatively, “Once you have staff, you can hire other physician investigators to diversify” before embarking on a freestanding clinical-trials practice. Whichever route a practice chooses, Dr. Beer says, “It’s very important that you have one full-time study coordinator. ... Find somebody who’s interested in clinical trials. They may not be highly ex- Quotable perienced,” but this person must be familiar with good clinical practice and open to learning the clinical-trial ropes. He suggested using resources such as online tutorials available from the National Institutes of Health, as well as journals, organizations and meetings devoted to clinical trials. Along with good clinical practice, Dr. Beer says that physicians and their staff also must be familiar with informed consent, recruitment, budgeting, negotiating, and space and staff requirements. “If you’re doing 12 studies, you’ll probably need three coordinators,” he notes. Additionally, Dr. Beer says it’s important to show sponsors that your staff is being continuously educated. “But at least up front, the educational requirements are manageable.” Often, he says, drug companies will initiate trials by approaching experienced investigators. If this happens, “You can pick and choose which ones you’ll participate in. The downside is, you must toe the line. You can’t create anything new” within the study protocol. Travel to investigator meetings andhosting monitoring visits from sponsors and/or the Food and Drug Administration (FDA) are required. Ultimately, “You have to figure out if it’s worth the time and money.” REVENUES see page 52 DTExtra Te employee handbook should be reviewed annually and updated for changes in employment law and growth of practice.” Melanie Palm, M.D., M.B.A. Solana Beach, Calif. On the process for creating a handbook See story page 50 The Centers for Medicare and Medicaid Services (CMS) has issued new guidance on reporting requirements for continuing medical education (CME) activities. The latest update seeks to clarify when manufacturers are required to report information about payments made to CME activities, despite a proposed elimination of the reporting requirement by CMS back in July and an affirmation of the elimination in October. Confusion over the apparently contradictory rule is the latest hiccup for CMS’s Open Payments system, which is part of the ACA’s Sunshine Act. READ MORE: BIT.LY/CMEREPORTING magenta cyan yellow black ES556603_DT0215_042.pgs 01.21.2015 03:28 ADV PROVEN EFFICACY CUSTOMIZED, WITH WEIGHT-BASED1,2 DOSING • SigniHcant reduction in inIammatory lesions at C1 mgkgday in SOLODYN®-treated patients1,2 – In a dose-ranging study, a 56.8% reduction from baseline vs placebo (39.4%)* – In 2 phase 3 trials, mean percent improvement from baseline was 43% and 46% vs placebo (32% and 31%, respectively)† • Once-daily dosing, with or without food1 • No generic equivalent * hase 2 study; N=233 subjects. † N=924 subjects. Indication and Usage SOLODYN is indicated to treat only inIammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Important Safety Information for SOLODYN Tablets use of tetracyclines with oral life-threatening; therefore, it • The most commonly observed contraceptives may render oral adverse reactions are headache, is important to consider this contraceptives less effective diagnosis in patients who fatigue, dizziness, and pruritus present with diarrhea subsequent • This drug is contraindicated in • Minocycline like other to the administration of persons who have shown tetracycline-class drugs antibacterial agents hypersensitivity to any of the can cause fetal harm when tetracyclines • Central nervous system side administered to a effects, including lightpregnant woman • Safety beyond 12 weeks of use headedness, dizziness, and has not been established • Tetracycline drugs should not be vertigo, have been reported used during tooth development • Cases of anaphylaxis, serious with minocycline therapy (last half of pregnancy and up to skin reactions, erythema 8 years of age) as they may cause • In rare cases, photosensitivity multiforme, and drug rash with has been reported permanent discoloration of teeth eosinophilia and systemic symptoms have been reported • seudomembranous colitis has • Should not be used during pregnancy or by individuals of postmarketing with minocycline been reported with nearly all either gender who are attempting use. Discontinue SOLODYN antibacterial agents and may to conceive a child; concurrent immediately if symptoms occur range from mild to Please see Brief Summary of full Prescribing Information on the following pages. References: 1. SOLODYN Tablets Package Insert. Scottsdale, AZ: Valeant Dermatology; February 2012. 2. Data on fle, Valeant Pharmaceuticals. Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. ©2014 Valeant Pharmaceuticals North America LLC. DM/SDN/14/0005 magenta cyan yellow black ES555417_DT0215_043_FP.pgs 01.17.2015 01:26 ADV BRIEF SUMMARY (see package insert for full prescribing information) SOLODYN® (minocycline HCl, USP) Extended Release Tablets Rx Only KEEP OUT OF REACH OF CHILDREN INDICATIONS AND USAGE Indication SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. animals treated early in pregnancy (see Use in Specific Populations). Pseudomembranous Colitis Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of To reduce the development of drugthe drug alone. In moderate to severe resistant bacteria as well as to maintain the cases, consideration should be given to effectiveness of other antibacterial drugs, management with fluids and electrolytes, SOLODYN should be used only as indicated protein supplementation, and treatment (see Warnings and Precautions). with an antibacterial drug clinically effective against Clostridium difficile colitis. CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. WARNINGS AND PRECAUTIONS Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. SOLODYN should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child (see Nonclinical Toxicology & Use in Specific Populations). B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT. C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in black Hepatotoxicity Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne. Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable. Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued. Benign Intracranial Hypertension Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines. If visual disturbance occurs during treatment, patients should be checked for papilledema. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri. drug-resistant bacteria to develop during the use of SOLODYN, it should be used only as indicated. Superinfection As with other antibiotic preparations, use of SOLODYN may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, SOLODYN Autoimmune Syndromes should be discontinued and appropriate Tetracyclines have been associated with the therapy instituted. development of autoimmune syndromes. Laboratory Monitoring The long-term use of minocycline in the Periodic laboratory evaluations of organ treatment of acne has been associated systems, including hematopoietic, renal with drug-induced lupus-like syndrome, and hepatic studies should be performed. autoimmune hepatitis and vasculitis. Appropriate tests for autoimmune syndromes Sporadic cases of serum sickness have should be performed as indicated. presented shortly after minocycline ADVERSE REACTIONS use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In Clinical Trial Experience symptomatic patients, liver function tests, Because clinical trials are conducted under ANA, CBC, and other appropriate tests prescribed conditions, adverse reaction should be performed to evaluate the rates observed in the clinical trial may not patients. Use of all tetracycline-class drugs reflect the rates observed in practice. should be discontinued immediately. The following table summarizes selected Photosensitivity adverse reactions reported in clinical trials Photosensitivity manifested by an at a rate of ≥1% for SOLODYN. exaggerated sunburn reaction has been Selected Treatment-Emergent Adverse observed in some individuals taking Reactions in at least 1% of Clinical tetracyclines. This has been reported Trial Subjects rarely with minocycline. Patients should Adverse Reactions SOLODYN PLACEBO minimize or avoid exposure to natural or (1 mg/kg) N=364 artificial sunlight (tanning beds or UVA/B N=674 (%) (%) treatment) while using minocycline. If At least one treatment- 379 (56) 197 (54) patients need to be outdoors while using minocycline, they should wear loose-fitting emergent event 152 (23) 83 (23) clothes that protect skin from sun exposure Headache 62 (9) 24 (7) and discuss other sun protection measures Fatigue Dizziness 59 (9) 17 (5) with their physician. Pruritus 31 (5) 16 (4) Serious Skin/Hypersensitivity Malaise 26 (4) 9 (3) Reaction Mood alteration 17 (3) 9 (3) Cases of anaphylaxis, serious skin reactions Somnolence 13 (2) 3 (1) (e.g. Stevens Johnson syndrome), erythema 10 (2) 1 (0) multiforme, and drug rash with eosinophilia Urticaria 10 (2) 5 (1) and systemic symptoms (DRESS) syndrome Tinnitus Arthralgia 9 (1) 2 (0) have been reported postmarketing with Vertigo 8 (1) 3 (1) minocycline use in patients with acne. Dry mouth 7 (1) 5 (1) DRESS syndrome consists of cutaneous Myalgia 7 (1) 4 (1) reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more Postmarketing Experience of the following visceral complications Adverse reactions that have been reported such as: hepatitis, pneumonitis, nephritis, with minocycline hydrochloride use in a myocarditis, and pericarditis. Fever and variety of indications include: lymphadenopathy may be present. In some Skin and hypersensitivity reactions: cases, death has been reported. If this fixed drug eruptions, balanitis, erythema syndrome is recognized, the drug should be multiforme, Stevens-Johnson syndrome, discontinued immediately. anaphylactoid purpura, photosensitivity, Tissue Hyperpigmentation pigmentation of skin and mucous Tetracycline-class antibiotics are known membranes, hypersensitivity reactions, to cause hyperpigmentation. Tetracycline angioneurotic edema, anaphylaxis, DRESS therapy may induce hyperpigmentation in syndrome (see Warnings and Precautions). many organs, including nails, bone, skin, Autoimmune conditions: polyarthralgia, eyes, thyroid, visceral tissue, oral cavity pericarditis, exacerbation of systemic lupus, (teeth, mucosa, alveolar bone), sclerae and pulmonary infiltrates with eosinophilia, heart valves. Skin and oral pigmentation transient lupus-like syndrome. has been reported to occur independently Central nervous system: pseudotumor of time or amount of drug administration, cerebri, bulging fontanels in infants, whereas other tissue pigmentation has decreased hearing. been reported to occur upon prolonged administration. Skin pigmentation includes Endocrine: brown-black microscopic thyroid diffuse pigmentation as well as over sites discoloration, abnormal thyroid function. of scars or injury. Oncology: thyroid cancer. Development of Drug Resistant Oral: glossitis, dysphagia, tooth Bacteria discoloration. Bacterial resistance to the tetracyclines may develop in patients using SOLODYN, Gastrointestinal: enterocolitis, pancreatitis, therefore, the susceptibility of bacteria hepatitis, liver failure. associated with infection should be Renal: reversible acute renal failure. considered in selecting antimicrobial Hematology: hemolytic anemia, therapy. Because of the potential for thrombocytopenia, eosinophilia. ES555373_DT0215_044_FP.pgs 01.17.2015 01:24 ADV Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Nonclinical Toxicology). DRUG INTERACTIONS Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. systemic exposure to minocycline observed in patients as a result of use of SOLODYN). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to Penicillin pregnant rats from day 6 of gestation Since bacteriostatic drugs may interfere through the period of lactation (postpartum with the bactericidal action of penicillin, it is day 20), at dosages of 5, 10, or 50 advisable to avoid giving tetracycline-class mg/kg/day. In this study, body weight gain drugs in conjunction with penicillin. was significantly reduced in pregnant females that received 50 mg/kg/day Methoxyflurane (resulting in approximately 2.5 times the The concurrent use of tetracycline and methoxyflurane has been reported to result systemic exposure to minocycline observed in patients as a result of use of SOLODYN). in fatal renal toxicity. No effects of treatment on the duration of Antacids and Iron Preparations the gestation period or the number of live Absorption of tetracyclines is impaired by pups born per litter were observed. Gross antacids containing aluminum, calcium external anomalies observed in F1 pups or magnesium and iron-containing (offspring of animals that received preparations. minocycline) included reduced body size, improperly rotated forelimbs, and reduced Low Dose Oral Contraceptives size of extremities. No effects were In a multi-center study to evaluate the observed on the physical development, effect of SOLODYN on low dose oral behavior, learning ability, or reproduction contraceptives, hormone levels over one of F1 pups, and there was no effect on menstrual cycle with and without gross appearance of F2 pups (offspring SOLODYN 1 mg/kg once-daily were of F1 animals). measured. Based on the results of this trial, minocycline-related changes in Nursing Mothers estradiol, progestinic hormone, FSH and Tetracycline-class antibiotics are excreted LH plasma levels, of breakthrough in human milk. Because of the potential for bleeding, or of contraceptive failure, serious adverse effects on bone and tooth cannot be ruled out. To avoid contraceptive development in nursing infants from the failure, female patients are advised to use tetracycline-class antibiotics, a decision a second form of contraceptive during should be made whether to discontinue treatment with minocycline. nursing or discontinue the drug, taking into account the importance of the drug to the Drug/Laboratory Test Interactions mother (see Warnings and Precautions). False elevations of urinary catecholamine levels may occur due to interference with Pediatric Use the fluorescence test. SOLODYN is indicated to treat only inflammatory lesions of non-nodular USE IN SPECIFIC POPULATIONS moderate to severe acne vulgaris Pregnancy in patients 12 years and older. Teratogenic Effects: Pregnancy category D Safety and effectiveness in pediatric (see Warnings and Precautions) patients below the age of 12 has not been established. SOLODYN should not be used during pregnancy. If the patient becomes pregnant Use of tetracycline-class antibiotics below while taking this drug, the patient should be the age of 8 is not recommended due to apprised of the potential hazard to the fetus the potential for tooth discoloration (see and stop treatment immediately. Warnings and Precautions). There are no adequate and well-controlled Geriatric Use studies on the use of minocycline in Clinical studies of SOLODYN did not pregnant women. Minocycline, like other include sufficient numbers of subjects aged tetracycline-class drugs, crosses the 65 and over to determine whether they placenta and may cause fetal harm when respond differently from younger subjects. administered to a pregnant woman. Other reported clinical experience has not NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows: Carcinogenesis—Long-term animal studies have not been performed to evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats. NDC 99207-466-30 Mutagenesis—Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Impairment of Fertility—Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis. Bottle of 30 The 105 mg extended release tablets are purple, unscored, coated, and debossed with “DYN-105” on one side. Each tablet contains minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: NDC 99207-467-30 Bottle of 30 The 115 mg extended release tablets are green, unscored, coated, and debossed with “DYN-115” on one side. Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows: NDC 99207-464-30 Bottle of 30 Storage Store at 25ºC (77ºF); excursions are permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. Handling Keep out of reach of children Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure. U.S. Patents 5,908,838; 7,790,705; 7,919,483; and Patents Pending* *90 mg is also covered by U.S. Patents 7,541,347 and 7,544,373 Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 02/2012 17110264 SOLODYN should not be used by individuals of either gender who are attempting to conceive a child. HOW SUPPLIED/STORAGE AND HANDLING How Supplied SOLODYN (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 55 mg, 65 mg, 80 mg, 105 mg or 115 mg minocycline, are supplied as follows. The 55 mg extended release tablets are pink, unscored, coated, and debossed with “DYN-055” on one side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied identified differences in responses between as follows: Rare spontaneous reports of congenital the elderly and younger patients. In general, anomalies including limb reduction have Bottle of 30 dose selection for an elderly patient should NDC 99207-465-30 been reported with minocycline use in be cautious, usually starting at the low end The 65 mg extended release tablets are pregnancy in post-marketing experience. of the dosing range, reflecting the greater Only limited information is available blue, unscored, coated, and debossed frequency of decreased hepatic, renal, or regarding these reports; therefore, no with “DYN-065” on one side. Each tablet cardiac function, and concomitant disease contains minocycline hydrochloride conclusion on causal association can or other drug therapy. be established. equivalent to 65 mg minocycline, supplied as follows: Minocycline induced skeletal malformations OVERDOSAGE (bent limb bones) in fetuses when In case of overdosage, discontinue NDC 99207-463-30 Bottle of 30 administered to pregnant rats and rabbits in medication, treat symptomatically and doses of 30 mg/kg/day and 100 mg/kg/day, institute supportive measures. Minocycline The 80 mg extended release tablets are dark gray, unscored, coated, and debossed respectively, (resulting in approximately is not removed in significant quantities by with “DYN-080” on one side. Each tablet 3 times and 2 times, respectively, the hemodialysis or peritoneal dialysis. black ES555390_DT0215_045_FP.pgs 01.17.2015 01:25 ADV 46 BUSINESS OF DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Art Gross is co-founder, president and CEO of Entegration. He started a second company, HIPAA Secure Now!, focused on the unique IT requirements of medical practices. Email Mr. Gross at [email protected] The business of selling patient records Protect from break-ins by performing a Security Risk Assessment Criminals are after your patients’ medical records, plain and simple. The number of criminal cyberattacks reported by healthcare organizations jumped to 40 percent in 2013 from 20 percent in 2009, according to an annual survey by the Ponemon Institute. Whether it’s an ex-employee with a grudge, a crime ring defrauding the government, or a nation state hacking a giant enterprise, these criminals see big profits in the health data residing on your organization’s computers. One anonymous emailer threatened to release the medical records of clinic patients from a hospital in Illinois if he didn’t receive a substantial ransom. Whether it’s an ex-employee with a grudge, a crime ring defrauding the government, or a nation state hacking a giant enterprise, criminals see big profits in the health data residing on your organization’s computers. In California, narcotics investigators took down a drug ring and confiscated thousands of patient records allegedly being used to obtain pre- magenta cyan yellow black scription drugs to produce methamphetamine. FINANCIAL INCENTIVES The financial incentive to steal patient information is huge - one lost or stolen patient record is valued at $50 on the black market. Some sources estimate that medical information is worth 10 times more than a credit card number. Surprisingly, criminals selling health information on the black market is a risk largely being ignored by senior management, according to a recent article in the Wall Street Journal (December 22, 2014). SECURITY RISK ASSESMENTS PROTECT PRACTICES FROM BREAK-INS Medical practices need to inoculate themselves against security break-ins by performing a Security Risk Assessment. A Security Risk Assessment looks at how patient information is current ly protected. It identif ies potential exposures and recommends measures designed to prevent the likelihood of a threat and lessen its impact. Security Risk Assessments consider such questions as: ➧ How often does the practice perform data backups? ➧ Is there a termination procedure? ➧ Do employees have the minimum level of access to patient information? ASSESSMENT TARGET AREAS Here are the areas that Security Risk Assessments target to protect valuable patient information: Inventory patient information — Locate where patient information is stored, accessed, or transmitted. Patient information could be EHRs (Electronic Health Records) but could also be Microsoft Word documents, such as patient letters, Excel spreadsheets as billing reports, or scanned images of EOBs (Insurance Explanation of Benefits). Think twice before you take your patient records home to review digital x-rays. A hacker may be viewing them too. These documents could be on employee’s desks or on laptop computers. Patient information could also be in emails or text messages in smartphones or tablets. Secure and protect all portable devices — This step is particularly critical for devices that contain patient information. Point of fact: according to IBM’s 2014 Cyber Security Intelligence Index Report, breaches are much more likely due to human error — like lost devices — than to hackers. Encrypt your data not only to protect against attacks, but also to help alleviate any potential penalties. Regulators will take into account whether a firm did all it could to protect the data. Everyone is a target — from a small medical practice to billion dollar companies like Sony. Think twice before you take your patient records home to review digital x-rays. A hacker may be viewing them too. DT ES556975_DT0215_046.pgs 01.21.2015 23:19 ADV Submental Fullness IN FOCUS No matter the view, submental fullness associated with subcutaneous fat can detract from an otherwise balanced and harmonious facial appearance1 – leading to an older and heavier look.2 According to a 2014 survey by the American Society for Dermatologic Surgery, 68% of consumers are bothered by submental fullness.3 Learn more from the experts at submentalfullness.com Tina Alster, MD Doris Day, MD Steven Dayan, MD, FACS Lisa Donofrio, MD Julius Few, MD, FACS References: 1. Swift A, Remington K. BeautiPHication: a global approach to facial beauty. Clin Plast Surg. 2011; 38:347-77. 2. Dayan S. Neck rejuvenation. In: Hirsch, Aesthetic Rejuvenation: A Regional Approach. 1st ed. New York, NY: McGraw Hill Professional Publishing; 2008: 123-147. 3. American Society for Dermatologic Surgery 2014 Consumer Survey on Cosmetic Dermatologic Procedures (N=8,315); Exact survey language was, “How bothered are you by excess fat under the chin/neck?” Copyright ©2015 KYTHERA Biopharmaceuticals, Inc. All rights reserved. submentalfullness.com magenta cyan yellow black ES557426_DT0215_047_FP.pgs 01.22.2015 04:21 ADV 48 BUSINESS OF DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Cheryl Bisera is a marketing consultant, author and speaker with extensive experience in marketing and business promotion. She is founder of Cheryl Bisera Consulting, a California-based image development and marketing company that focuses on the healthcare industry. Ms. Bisera is also the co-author of The Patient-Centered Payoff, published by Greenbranch Publishing. PART 3 OF 4 GETTING PAID IN THE NEW HIGH DEDUCTIBLE LANDSCAPE The technology factor: Tools to help you collect from patients s healthcare costs rapidly shift to patients in the form of high deductible plans, a larger portion of practice revenue is dependent on the collection of patient portion. Practices that are unable to successfully collect from or make payment agreements with patients at the time of service will see increased bad debt and be at significant financial risk moving into the future. A these businesses will accommodate our preferred payment methods. Additionally, patient collection efforts need to be consistent and humans simply aren’t as reliably consistent as automated systems. It’s important to consider taking advantage of anything your practice management vendor offers to support your efforts to relieve the administrative burden from your staff. If you want to increase practice profitability and haven’t mastered patient collections, consider how you might employ technology to help you succeed in the new high deductible landscape If you want to increase practice profitability and haven’t mastered patient collections, consider how you might employ technology to help you succeed in the new high deductible landscape. Doing so will both support and expedite the collection efforts of staff and the payment efforts of patients. It’s time that healthcare providers catch up with other industries in their consumerfocused strategies that get you paid sooner rather than later! After all, no one thinks twice about handing their major credit card over to pay their mechanic, paying in full at the grocery store or paying at the time of ordering purchases online – it’s expected that we will pay at time of service and it’s expected that magenta cyan yellow black HERE IS A CHECKLIST TO GET YOU STARTED: ➧ Utilize your Web site or patient portal to give patients access to your patient financial policy, their balance and payment opportunities. ➧ Use appointment reminder calls to also confirm insurance and co-pay information ➧ Institute reminder calls, texts and e-mails to patients about balances due; some systems offer live operators to allow patients to pay over the phone after hours. ➧ Utilize a payment estimator and/or real time claims adjudicator to help patients prepare to pay and give staff confidence in asking for payment at time of service. ➧ Use insurance eligibility verification during scheduling, reminder or check in. ➧ Accept all major credit cards — if integrated directly into your system, patients can be set up on a monthly payment plan. You could be sending them a receipt each month instead of a bill! ➧ Set up secure “credit card on file” and add automatic payment to your patient financial policy for patients who want this convenience — also called “bill on EOB” with the security of a maximum cap on the amount for patient assurance. ➧ Insure staff has the ability to scan insurance cards, process check payments, credit cards, and HSA or FSA cards. ➧ Empower staff and educate patients with a system that allows any staff member to pull up a patients balance and print an EOB when asked for an explanation of their balance. Keep in mind; technology will never replace the personal touch that a properly trained and naturally suited staff member can bring to this process. It’s also important that all members of your practice team understand the practice financial policy and their part in reinforcing it with patient-friendly language. However, utilizing technological tools to support your staff’s efforts to communicate to patients before, during and after visits will significantly increase your chances of getting full payment by your patients before they even leave your office. DT ES556606_DT0215_048.pgs 01.21.2015 03:28 ADV Want more? We’ve got it. Just go mobile. Our mobile app for iPad® brings you expanded content for a tabletoptimized reading experience. Enhanced video viewing, interactive data, easy navigation—this app is its own thing. And you’re going to love it. Download the app now: dermatologytimes.com/gomobile Clinical Analysis for Today’s Skincare Specialists iPad is a registered trademark of Apple Inc. magenta cyan yellow black ES555387_DT0215_049_FP.pgs 01.17.2015 01:25 ADV 50 BUSINESS OF DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM Melanie D. Palm, M.D., M.B.A. is director of Art of Skin MD in Solana Beach, California Why it’s a good time to create or revamp your employee handbook T he employee handbook is the standard by which a clinical practice operates, best systems are outlined, and employee rights and conduct are described. It may not be the immediate priority as a physician opens a new practice or as an established physician or group oversees a practice year to year. However, with the approach of a new year, it is an ideal time to review the old handbook or finally create one if it does not yet exist. Creating or revamping your employee handbook is a task made easier with the help of an expert. Although the employee handbook can be created by the physician, it requires a current and extensive knowledge of labor law, employee rights, and best practices. By enlisting the help of an adviser, with limited effort on your part, a thorough handbook can be created, tailor made to your practice for a relatively nominal cost. Various sources can serve as an expert to usher you through this process, including an employment lawyer, human resources expert, or a practice consultant. In selecting an adviser for the creation of an employee handbook, it is important to ask a few questions: ➧ How many years of experience does he or she have in constructing employee handbooks? ➧ Have they performed this for clients of similar business sizes or within the same industry? ➧ How will the handbook be tailormade to the practice? ➧ What is the fee schedule? ➧ Will the fee include consultation and review of the materials? ➧ How often will they update the employee handbook and at what cost? magenta cyan yellow black ➧ Will they help in explaining it to your staff members upon completion? ➧ Will they provide supplementary documents at no additional cost? THE PROCESS FOR CREATING YOUR HANDBOOK The process for constructing an employee handbook is straightforward and efficient with the use of a “consultant”. Having been through the process several times myself, there is a common method for extracting information specific to your practice and integrating this into the finalized handbook. Typically, you will be provided with a questionnaire that takes approximately an hour or so to fill out. This will be worked into a handbook “framework” thereby customizing your document. The questionnaire covers a variety of topics around major themes of the handbook: policies, practices, and benefits. Information gained from the questionnaire ranges from organizational information, company standards and procedures, operational standards, hourly pay and wages, benefits and services, standards of conduct, and employee safety. If some topics covered have not been initiated by a clinic practice, the creation of the handbook becomes an excellent vehicle in which to start. Many sections of the employee ha ndbook relat i ng to employee rights and responsibilities vary by geographic location and local and state jurisdiction. Other areas, however, are partially or totally at the clinic leadership’s discretion. Educational opportunities, holiday schedules, timekeeping, and bereavement leave are in many instances benefits offered by the employer and variable depending on practice preferences. Standards of conduct are another important area to highlight with employees. Prohibited conduct, dress code, telephone and Internet use, and policies on video surveillance protect the safety of our patients and help shape the culture of the practice. Making this clear from the onset of employment sets the bar for employee conduct. Similarly, this clear set of accepted policies provides substantial protection for practices in dealing with employee suspension or termination with cause. Several supplementary documents were particularly helpful in my last round of updat ing t he employee handbook and are worth sharing with others. Intellectual property and trade secrets of a well-functioning practice should be protected. For that reason, all employees AND visitors to my practice sign a non-disclosure agreement. Beyond the standard employee acknowledgement that all staff sign upon reviewing the employee handbook. I also have employees sign an arbitration agreement and acknowledgement. This prov ides another layer of protection in the event of frivolous claims from ex-employees. Other agreement forms to consider are substance abuse and drug-free workplace policies, systems use policies, meal break waiver agreements, and HIPAA compliance agreements. The employee handbook should be reviewed annually and updated for changes in employment law and growth of the practice. Extra credit goes to practices that review the employee handbook with staff annually and emphasize regularly at staff meetings the best practices put forth in the handbook. DT ES556488_DT0215_050.pgs 01.21.2015 01:33 ADV Xoft [ `zôft ] verb: making my weekly golf game, every week At Xoft, we are r e d e f i n i n g t h e f u t u r e of n o n - m e l a n o m a s k i n c a n c e r (NMSC) treatment. Because like you, we believe in an advanced p e r s o n a l , p a i n l e s s , p r o v e n 1 and e f f i c i e n t approach to treating NMSC. Our s t a t e - o f - t h e - a r t radiation therapy technology will i m p r o v e patient care and seamlessly e n h a n c e your workflow t o d a y to create a world with less NMSC t o m o r r o w. To learn more about Xoft skin visit www.xoftinc.com or electronic brachytherapy (eBx®) contact [email protected] In cooperation with the dermatologist, eBx® is administered under the supervision of a radiation oncologist. 1 Bhatnagar A. Electronic Brachytherapy for the Treatment of Nonmelanoma Skin Cancer: Results at 3 Years. Int J Radiat Oncol Biol Phys 2013;87:S65 ©2015 Xoft, a subsidiary of iCAD, Inc. All rights reserved. Axxent, Xoft and Electronic Brachytherapy System (eBx) are registered trademarks of iCAD, Inc. magenta cyan yellow black ES555420_DT0215_051_FP.pgs 01.17.2015 01:27 ADV 52 BUSINESS OF DERMATOLOGY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM REVENUES: Tips for diversifying your practice and adding revenue from page 42 INVESTIGATOR-INITIATED TRIALS Investigator-initiated trials, on the other hand, require one to generate an idea, such as a new use for a neuromodulator, and propose it to a company or other potential sponsor, Dr. Beer says. Landing clinical trials of any type requires networking, he adds. To get started, “If you have a friend in another state who is looking for additional sites for a trial that sounds interesting, let that friend know you’re interested.” If one publishes in a particular area such as acne, lasers, neuromodulators or fillers, Dr. Beer suggests opening the dialogue with a potential sponsor by communicating your interest to the appropriate sales representative. Of greater concern, he says, is that sloppiness and dishonesty in clinical trials can bring trouble from the FDA. In one such case, “A physician’s assistant was doing trials and patient care at the same time and was found to be making up data. The FDA shut the site down.” Additionally, “Recruiting can be difficult.” If your practice lacks a strong patient base and/or staff and fails to recruit the patients required for a study, Dr. Beer says, the sponsoring company will be disappointed because it will have spent money initiating your study site. Above all, “Don’t just do clinical trials for money. However, if you’re interested in practice diversity, and it’s the type of thing that intellectually fascinates you, it can be a good direction to take.” DISPENSING IN-OFFICE PRODUCTS Among product categories, he says that the acquisitions of NeoCutis and SkinMedica indicate that cosmeceuticals are booming and should remain a relatively stable source of growth. “To this day,” he adds, “tretinoin and retinol are generally the most popular products that we deal with.” Other basic cosmeceutical categories include acids, vitamins, antioxidants, growth factors and DNA repair products. In dispensing such products, “Our goal as dermatologists is to add value and deliver products that are superior to what patients can get at department stores from somebody with a high school education.” magenta cyan yellow black Dermatologists bear an obligation to educate patients about claims made on infomercials that certain products are better than FDA-approved prescription treatments, or that an over-the-counter or Internet product will take several years off the purchaser’s appearance. “If a skincare product is saying it can take 10 years off, and the maker of Botox Cosmetic (onabotulinum toxin A, Allergan) is saying it can take five years off, which way are patients going to go? We should educate our patients about the right products for their skin type, medical conditions, geography, goals and budget. Then we can use privatelabel or brand-name products to individualize their treatment.” “Don’t just do clinical trials for money. However, if you’re interested in practice diversity, and it’s the type of thing that intellectually fascinates you, it can be a good direction to take.” Kenneth Beer, M.D. West Palm Beach, Fla. In the former area, Dr. Beer commonly gets calls from companies interested in developing stem-cell or cytokine-based beauty products. “I’m always interested, because I believe they hold a lot of potential.” But thus far, he finds the data unconvincing. And whenever he has explored these opportunities, he says, they involve non-dermatologists mixing unapproved ingredients, usually bought online, in unapproved facilities. “They don’t know anything about skincare or cytokines — but they are considered the gurus, and our patients are going to them,” he says. Instead, he says that dermatologists interested in developing private-label products should stick to approved ingredients and reputable, properly insured laboratories. Taking these measures does not guarantee success, however. His practice offers a customized sun protection product, but it’s difficult to compete against established manufacturers with great formulas, name recognition and substantial advertising budgets. On the other hand, Dr. Beer says, if one chooses to dispense an off-theshelf product, support is available. Sales representatives will bring brochures, educate your staff, and supervise your sales. Other forms of support offered by manufacturers include direct-to-consumer advertising, point-of-sale advertising and patient-loyalty programs, he notes. And if a product expires before it sells, “Manufacturers won’t like it, but they’ll take it back.” On the downside, the only factor that can distinguish your off-theshelf products from those of competitors is pricing, he says. Additionally, physicians can’t control manufacturers’ pricing or ingredients, or customize the marketing materials that appear in their practices. Along with clinical trials and product sales, he says, other ancillary revenue streams can include consulting — with established or startup companies, or in malpractice cases, to name a few possibilities. “There are many opportunities for adding revenue to your practice. It depends on your personality, risk tolerance and goals. We live in very uncertain times. I recommend that you consider alternative income sources, to diversify and stay engaged,” he says. DT For more information: www.cosmeticbootcamp.com Disclosures: Dr. Beer is the owner of ScientificRx Skincare. He has been a consultant and/or investigator for Allergan, Merz and Valeant, and virtually all makers of cosmeceuticals and inoffice products. He also is a cofounder of The Cosmetic Bootcamp, which will begin offering a clinical trials boot camp for physicians of all specialties at a time and location to be determined in 2015. ES556605_DT0215_052.pgs 01.21.2015 03:28 ADV WCD 2015 is presented under the auspices of the International League of Dermatological Societies. The ILDS has 157 national and international member organizations including the AAD, ASDS, and SID. Approved for AMA Physician ’s Recognition Aw ard Category 1 CME CreditTM A TRULY UNIQUE GLOBAL DERMATOLOGY EXPERIENCE THE WORLD’S LONGESTRUNNING DERMATOLOGY CONGRESS A FRIENDLY AND STUNNINGLY BEAUTIFUL HOST CITY PHOTO COURTESY OF TOURISM VANCOUVER SO MUCH TO SEE AND DO IN VANCOUVER Over 200 sessions, 1,500 speakers and 3,500 abstracts—all in ONE great meeting! www.derm2015.org magenta cyan yellow black ES555403_DT0215_053_FP.pgs 01.17.2015 01:25 ADV 54 TRADE TOOLS FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM TRAVEL FRIENDLY MAKEUP ORGANIZER QOSMEDIX has introduced a new PVC Cylinder Brush Holder for storing and protecting makeup brushes. The holder includes a secure strap and snap closure on both sides. When not being used for travel, the brush holder can be divided into two separate pieces to display brushes, tweezers, nail scissors, nail files or other accessories on a retail counter or personal vanity. Dermatologist launches skin type solutions DR. LESLIE BAUMANN , a Miami dermatologist has developed the Skin Type Solutions franchise business model. The business model allows dermatologists to be the primary source of skincare guidance before a patient makes a purchase, and can provide patients with the skincare products necessary for their unique skin type. Also, it provides dermatologists products and education necessary to prescribe effective, customized skincare regimens according to the company DR. LESLIE BAUMANNE QOSMEDIX www.qosmedix.com NEW ULTRA SLIM, ERGONOMIC SURGICAL PLUME EVACUATION PENCIL BUFFALO FILTER announced it’s next generation surgical plume evacuation pencil, PlumePen Elite. It’s compact, ultra slim and ergonomic. Also, it includes an adjustable cap- www.stsfranchise.comm BABY BALM NOW CLINICALLY HYPOALLERGENIC AND NON-IRRITATING AVISHI ORGANICS, announced that its intensive Baby Balm has been clinically tested under dermatologist review, and is hypoallergenic and non-irritating, making it suitable for use on babies and those with sensitive skin, according to the company. The balm was subjected to the Human Repeat Insulin Path Test, on 50 people over 6 weeks, the company says. The test found it to be non-irritating with a low risk of causing allergic reactions. The baby balm contains Neem oil for treating a number of skin problems, coconut oil for soothing inflamed skin and minimizing skin flaking, castor oil, a natural emollient that helps make skin softer and smother, and plantain for soothing itchy skin. ture port; an over-molded button design that helps to prevent buttons from sticking; a full blade reveal for visibility at the surgical site; a 360 degree swivel that allows for fluid hand movement and free range of motion; and light and flexible tubing that aids in reducing pull, hand fatigue, and tension on the wrist, according to the company AVISHI ORGANICS www.avishiorganics.com BUFFALO FILTER www.b uffa l ofi lt e r.c o m magenta cyan yellow black ES557349_DT0215_054.pgs 01.22.2015 02:44 ADV CALENDAR/ AD INDEX FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM 55 ad index ADVERTISER PRODUCT WEBSITE ACTELION PHARMACEUTICALS VALCHLOR www.valchlor.com 33 - 34 ALLERGAN MEDICAL VOLUMA www.juvederm.com CV2 BAYER HEALTHCARE PHARMACEUTICALS FINACEA www.finacea.com 27 CANFIELD SCIENTIFIC VEOS PAGE www.canfieldscientific.com 55 CELGENE CORPORATION OTEZLA www.celgene.com 4-6 ELEKTA ESTEYA www.esteya.com COVERTIP GALDERMA LABORATORIES EPIDUO www.epiduo.com 15 - 16 GALDERMA LABORATORIES SOOLANTRA iCAD INC XOFT KYTHERA BIOPHARMACEUTICALS LEO PHARMA INC TACLONEX LIVE OAK BANK MERZ PHARMACEUTICALS www.soolantra.com 51 www.submentalfullness.com 47 www.taclonex.com www.liveoakbank.com MEDERMA www.mederma.com MILLER ADVERTISING TARO PHARMACEUTICALS UNILEVER CV3 - CV4 www.xoftinc.com 23 - 24 37 9 57 TOPICORT SPRAY DOVE www.tarousa.com www.Doveprofessional.com/care 29 - 30 11 VALEANT PHARMACEUTICALS INTL CERAVE www.valeant.com 13 VALEANT PHARMACEUTICALS INTL RETIN-A MICRO www.valeant.com 39 - 40 VALEANT PHARMACEUTICALS INTL SOLODYN www.valeant.com 43 - 45 VEGAS COSMETIC SURGERY MEETING www.vegascosmeticsurgery.info 56 WORLD CONGRESS OF DERMATOLOGY www.derm2015.org 53 VISIA® This index is provided as an additional service. The publisher does not assume any liability for errors or omissions. ® IntelliStudio® VEOS® Reveal® HAND-HELD 3D CAMERA magenta cyan yellow black innovative 3D imaging www.canfieldscientific.com [email protected] | +1.973.276.0336 ES557018_DT0215_055.pgs 01.22.2015 00:37 ADV The 11th Annual ded d A t Jus al n o i t na Inter nd Body ta E Breas for BC/B s on Sessi Surgeon ic Plast Endorsed by: www.VegasCosmeticSurgery.com magenta cyan yellow black ES555374_DT0215_056_FP.pgs 01.17.2015 01:24 ADV ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM THE TAKEAWAY 57 Considering alternatives Dermatology Times editorial advisor, Elaine Siegfried, M.D., talks with Peter Lio, M.D., assistant professor of clinical dermatology and pediatrics at Northwestern University’s Feinberg School of Medicine, and private practice, Dermatology and Aesthetics of Wicker Park, Wicker Park, Chicago, about his interest in alternative medicine and when he might consider certain techniques and therapies. ELAINE SIEGFRIED, M.D. DR. SIEGFRIED: When and how did you become interested in alternative medicine? A Dr. Lio: I think the first memory I have about alternative medicine was as a boy, maybe in high school. I saw a show on PBS about acupuncture. Watching the acupuncturists’ healing techniques and seeing the patients before and after really affected me. I think that actually shaped part of the reason I wanted to go into medicine. In medi- Listen to the discussion. bit.ly/alternativetherapyinderm cal school I was lucky enough to be able to spend a summer with Ted Kaptchuk, O.M.D., author, researcher, professor of medicine at Harvard Medical School and director of the Harvard-wide Program in Placebo Studies and the Therapeutic Encounter (PiPS) at Beth Israel Deaconess Medical Center in Boston, and David M. Eisenberg, M.D., who was then the director of the Center for Alternative Medicine and Education at Beth Israel Deaconess Medical Center and associate professor of medicine at Harvard Medical School. They were both doing interesting research and some deep thinking about alternative medicine, which was during the lead up to the development of the National Center ALTERNATIVES see page 64 LAST 2 UNITS LEFT Premier Medical Office Space in the Heart of Carnegie Hill for Lease PARK AVENUE MEDICAL ARTS CENTER 62 E 88th Street (btwn. Madison & Park Avenue) New York, NY Lower Level: 6,752 RSF Ground Level: 4,213 RSF Total: 10,965 RSF • • • • • Unique large block of medical space off of Park Avenue Exclusive new medical lobby with high-end finishes Space built-to-suit based upon generous workletter Private semi-circular driveway Public garage across the street Paul Wexler, Licensed Associate RE Broker o: 212.836.1075 | [email protected] Real estate agents affiliated with The Corcoran Group are independent contractor sales associates and are not employees of The Corcoran Group. Equal Housing Opportunity. The Corcoran Group is a licensed real estate broker located at 660 Madison Ave, NY, NY 10065. All information furnished regarding property for sale or rent or regarding financing is from sources deemed reliable, but Corcoran makes no warranty or representation as to the accuracy thereof. All property information is presented subject to errors, omissions, price changes, changed property conditions, and withdrawal of the property from the market, without notice. All dimensions provided are approximate. To obtain exact dimensions, Corcoran advises you to hire a qualified architect or engineer. magenta cyan yellow black ES557009_DT0215_057.pgs 01.22.2015 00:35 ADV 58 Dermatology Times | Products & Services SHOWCASE Go to: February 2015 products.modernmedicine.com EDUCATION UPCOMING CME ACTIVITIES Closure Course and Dermatologic Surgery: Focus on Skin Cancer Basal and Squamous Cell Cancer Pathology for Mohs Surgeons and Fundamentals of Mohs Surgery Hyatt Regency Grand Cypress – Orlando, Florida DoubleTree Hotel San Diego, Mission Valley – San Diego, California May 20-21, 2015 – Closure Course This intense learning experience provides didactic instruction and practical experience in multiple closure techniques, and includes numerous anatomic sitespecific discussions. A hands-on laboratory session allows for closely-monitored practice of new and complex reconstruction techniques on realistic visco-elastic models. Information presented in the course strongly complements the activities featured in Dermatologic Surgery: Focus on Skin Cancer (below), without direct overlap or duplication of material. November 4, 2015 – Basal and Squamous Cell Cancer Pathology for Mohs Surgeons Taught by Board-certified dermatopathologists, this intense one-day course will provide a “pure pathology” experience for physicians interested in understanding the subtler characteristics of basal and squamous cell carcinoma, the tumors most commonly treated with Mohs surgery. Participants will learn to accurately interpret BCC and SCC in all its variations, as well as to differentiate tumor characteristics from background findings, reactive changes present in recently biopsied tissue, etc. May 22-24, 2015 – Dermatologic Surgery: Focus on Skin Cancer Top experts in cutaneous oncology and dermatopathology will present a multifaceted program for dermatologists and dermatologic surgeons. Presenters in interactive panel discussions will share their unique perspectives on special tumor management, melanoma diagnosis and treatment, and reconstruction challenges. Advanced Mohs techs will receive updates on quality assurance measures, troubleshooting, safety, and regulatory compliance in the Mohs lab. Meeting provides an excellent follow-up to our Fundamentals of Mohs surgery technician training. November 5-8, 2015 – Fundamentals of Mohs Surgery Dermatologists and other specialists will be introduced to the basic surgical and histopathologic aspects of Mohs surgery, preparing a solid foundation for long-term proficiency in the procedure. Microscope laboratory case review and pathologist-led small group discussions will promote greater understanding and enhanced accuracy in this most critical facet of Mohs surgery. Intensive cryostat lab instruction will benefit Mohs technicians at all levels of training and experience, deepening their understanding of Mohs tissue processing and the importance of the physician-technician “team” in successful Mohs surgery. For additional information, please contact: Novella M. Rodgers, ASMS Executive Director Tel. 800.616.2767 or Email [email protected] EDUCATION 2015 ASDS Education Programming Learn experts’ techniques and best practices to optimize your results with these all-new courses! Premier Annual Resident Cosmetic Symposium April 17-19, 2015 Dallas, TX Directors: Susan H. Weinkle, MD Craig F. Teller, MD Plan nowd! to atten State-of-the-Art in Minimally Invasive Aesthetics: Anatomic Approach to the Face Advanced Injection Techniques: Maximize Safety and Minimize Complications June 8, 2015 Vancouver, BC, CANADA October 3-4, 2015 New York, NY (during the 23rd World Congress of Dermatology) Directors: Derek H. Jones, MD Alastair Carruthers, FRCPC Directors: Rebecca Fitzgerald, MD Shannon Humphrey, MD Practice Management, Marketing and Social Media July 18-19, 2015 Chicago, IL Directors: Cheryl Burgess, MD Jody A. Comstock, MD Visit asds.net/courses for more information! Search for the company name you see in each of the ads in this section for FREE INFORMATION! magenta cyan yellow black ES556154_DT0215_058_CL.pgs 01.20.2015 21:19 ADV February 2015 | 59 DermatologyTimes.com Go to: products.modernmedicine.com Products & Services SHOWCASE EDUCATION PRODUCTS >VUKLY^OH[ [OLZLHYL& COMPANY NAME Go to products.modernmedicine.com and enter names of companies with products and services you need. marketers, fnd out more at: advanstar.info/searchbar PRODUCTS & SERVICES ADVERTISING Call Karen Gerome to place your Showcase ad at 800.225.4569 ext. 2670 [email protected] Search for the company name you see in each of the ads in this section for FREE INFORMATION! magenta cyan yellow black ES556172_DT0215_059_CL.pgs 01.20.2015 21:20 ADV 60 Dermatology Times | Products & Services SHOWCASE Go to: February 2015 products.modernmedicine.com SERVICES LEAVITT Search Search for the company name you see in each of the ads in this section for FREE INFORMATION! magenta cyan yellow black ES556156_DT0215_060_CL.pgs 01.20.2015 21:19 ADV February 2015 | Marketplace DermatologyTimes.com 61 PRODUCTS & SERVICES EQUIPMENT FOR SALE Gently used SRT-100 (used for only 3 months). Superficial radiation approved for NMSC and keloids. Call Terri at (901) 604-9521 for details. PRACTICE FOR SALE NATIONAL GEORGIA PRACTICE FOR SALE NE GEORGIA We Buy Practices • Retiring • Monetization of your practice • Locking in your value now • Succession planning • Sell all or part of your practice This long established medical and surgical dermatology practice consistently collects $1,700,000 annually. Situated in 3,800 square feet freestanding building with 6 fully equipped exam rooms. The area is named as one of the top fve best places to live. Seller is available to facilitate a smooth transition. 100% Bank Financing Available. Please call Jeff Queen at (866) 488-4100 or email [email protected] www.MyDermGroup.com www.TransitionConsultants.com FLORIDA KENTUCKY (800) 416-2055 OTC PRODUCTS PRACTICE FOR SALE SOUTH FLORIDA Long established busy medical and surgical dermatology practice, consistently collecting $1,200,000+ annually on 4 days/week. Substantial growth potential by providing a wider array of services including Mohs. Seller willing to stay on to ensure a smooth transition 100% Bank Financing Available. (800) 416-2955 www.TransitionConsultants.com Clinical Analysis for Today’s Skincare Specialists Content Licensing for Every Marketing Strategy Marketing solutions fit for: Outdoor | Direct Mail | Print Advertising | Tradeshow/POP Displays | Social Media | Radio & TV Leverage branded content from Dermatology Times to create a more powerful and sophisticated statement about your product, service, or company in your next marketing campaign. Contact Wright’s Media to fnd out more about how we can customize your acknowledgements and recognitions to enhance your marketing strategies. For information, call Wright’s Media at 877.652.5295 or visit our website at www.wrightsmedia.com magenta cyan yellow black ES556153_DT0215_061_CL.pgs 01.20.2015 21:18 ADV 62 Marketplace Dermatology Times | February 2015 CAREERS FELLOWSHIP NATIONAL CALIFORNIA MEDICAL DERMATOLOGY FELLOWSHIP MOHS SURGEON MULTIPLE PART TIME OPPORTUNITIES San Diego, California MedDerm Associates, Inc. Montrose, CO 1-2 days/mo Enfield, CT 2-3 days/mo Groton, CT 1-2 days/mo Reno, NV 1-2 days/mo Hickory, NC 1-2 days/mo Sanford, NC 2-3 days/mo Bountiful, UT 3-4 days/mo Tampa, FL 1-2 days/mo Contact Karey, (866) 488-4100 or www.MyDermGroup.com 1 – 2 years experience in management of complex medical dermatology patients in both private practice & teaching clinic. Biologics, immunsuppressants, immunomodulators, clinical trials. PGY 5/6. Send CV & 2 LOR to: David Fivenson, MD. ²[email protected] ADVERTISE TODAY! Part-time/Full-time position Private practice, single specialty group General/Medical/Surgical/Cosmetic/Laser Great Benefits Email CV and Cover letter to [email protected] PORTERVILLE, CA Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com NATIONAL CONNECTICUT • Highly competitive salary • Full beneåts Advanced Dermatology and Cosmetic Surgery, the largest dermatology practice in the country with over 100 locations, is seeking immediate full time Fellowship Trained Mohs Surgeons and General/Cosmetic Dermatologists. The group is going through expansive growth and positions are immediately available. Excellent opportunity to build an offce practice! General/Cosmetic Derm Opportunities: • Full time – Central, FL • Full time – Jacksonville, FL • Full time – Orlando, FL • Full time – Tampa, FL • Full time – Vero/Sebastian, FL • Full time – Fort Collins, CO • Full time – Ft. Myers, FL • Full time – Lakeland, FL • Full time – Mason, OH • Full time – Albany, GA Mohs* Opportunities: • Full time - Jacksonville, FL • Full time - Orlando, FL • Full time - Ohio • Full time - Philadelphia, PA • Part-time - Spartanburg, SC For immediate consideration, send your CV today! * Multiple offces and Dermatologists feed into the Mohs surgery schedule Submit CV to Dave Morell at [email protected] or call 407-875-2080 x 1244 COLORADO PHOENIX ARIZONA BC/BE dermatologist position available PT/FT Premier dermatology practice. Five locations Excellent bene½ts and growth potential. Esteemed colleagues General dermatology • Cosmetic surgery MOHs surgery Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com 602-277-2307 • Fax : 602-277-9984 CALIFORNIA 13,7 surgeon needed Jor multioJ½ce practice in C% 2: and %>. Excellent pay and bene½ts. 7end C: to 1ichelle7$lalasercenter.com magenta cyan yellow black DISTRICT OF COLUMBIA WASHINGTON, DC Associate Opportunity Contact Karey, (866) 488-4100 or www.MyDermGroup.com FLORIDA START A NEW PRACTICE IN MIAMI BEACH! Dr. Matt Leavitt, Founder & CEO ARIZONA Email CV to [email protected] Arizona Dermatology Cindy McGrady GROTON, CONNECTICUT Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com Busy Derm offce seeking PT Dermatologist • Job available immediately • Stable long term position • Salary negotiable Please email resume to [email protected] BOULDER, COLORADO MONTROSE, COLORADO Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com Palm Beach Dermatology is looking for a Dermatopathologist/Dermatologist in West Palm Beach, Florida. We offer a generous compensation and benefts package. Visit our website for more information: www.palmbeachdermatology.com Please fax your CV to 561-640-8098 or email: [email protected] OCALA, FLORIDA Repeating an ad ENSURES it will be seen and remembered! Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com ES556155_DT0215_062_CL.pgs 01.20.2015 21:19 ADV February 2015 | Marketplace DermatologyTimes.com 63 CAREERS NORTH CAROLINA PENNSYLVANIA Tampa, FLORIDa HICKORY, NC Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com BC/BE Dermatologist PENNSYLVANIA FLORIDA Highly-regarded, thriving practice with 8 dermatologists seeks BC/BE Dermatologist. WEST PALM BEACH, FLORIDA Partnership available. Established practice Contact Karey, (866) 488-4100 or www.MyDermGroup.com State of the art 12,000 sq. ft. facility with SANFORD, NC Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com in-house Mohs, dermatopathology, phototherapy, lasers, aesthetic services, adult and pediatric medical dermatology. Excellent benefits, malpractice, health insurance, vacation/CME. Partner buy-in after 2 years. Located in an affluent, ILLINOIS highly picturesque, family-oriented community OKLAHOMA within 1 hour of Philadelphia and Baltimore. Call Bonnie Oberholtzer at (717) 509-5698 or e-mail to: [email protected] CHICAGO, ILLINOIS Partnership available. Established practice. Contact Karey, (866) 488-4100 or www.MyDermGroup.com Tulsa, Oklahoma NEW MEXICO SANTA FE, NEW MEXICO Partnership available. Established practice Contact Karey, (866) 488-4100 or www.MyDermGroup.com NEW JERSEY DERMATOLOGIST General/Cosmetic/Surgical Dermatology Medford, NJ (near Philadelphia, PA and Cherry Hill, NJ). Brand new state of the art offce, fabulous opportunity, benefts offered. FT/PT position available. Email inquiry or CV to: [email protected] NEW YORK BRONX, MANHATTAN, NYC The Skin Cancer Center at the Tulsa Cancer Institute is seeking a Board Certifed/Eligible Dermatologist to add to its practice of cutaneous oncology. Expertise and interest in melanoma and Mohs surgery required. The Tulsa Cancer Institute is the largest physician-owned oncology network in the state offering services at fve cancer centers throughout Oklahoma with board certifed physicians specializing in Medical Oncology, Radiation Oncology, Gyn-Oncology, and Dermatology/ Mohs Surgery. Excellent opportunity to join a patient centered practice in a collegial clinical atmosphere with academic and research opportunities as well as housed in a state of the art facility. Benefts include base salary guarantee with production bonus, health insurance, vacation/CME and the opportunity for partnership in 2 years. SEEKING SUPERVISING DERMATOLOGIST • Recently board certi½ed? • Retired? • Looking to go Part Time? • Looking to spend more time with the family? Well established, thriving, multi-center Dermatology practice seeking a Supervising Dermatologist with limited patient care responsibilities. Highly competitive compensation. EMAIL CV: [email protected] Well-established dermatology practice in Great Neck, NY, for close to 50 years, seeks a part-time/full-time dermatologist to join our present team of 4 general dermatologists, 1 Mohs surgeon and 2 plastic surgeons. Practice is mostly medically oriented but interested in increasing our cosmetic procedures in the future. Friendly, helpful staff. Flexible hours. Please forward cv to [email protected]. magenta cyan yellow black For further information contact: Edward H. Yob, DO at [email protected] or call 918-307-0215 OREGON UTAH BOUNTIFUL, UTAH Associate Opportunity Contact Karey, (866) 488-4100 or www.MyDermGroup.com RECRUITMENT ADVERTISING Can Work For You! Reach highly-targeted, market-specific business professionals, EUGENE, OREGON Part Time/Full Time Position General/Cosmetic/Surgical Dermatology Spectacular Scenic Beauty Excellent Benefts Fax CV & Cover Letter to 541-683-5206 Or Call 541-681-5090 industry experts and prospects by placing your ad here! ES556165_DT0215_063_CL.pgs 01.20.2015 21:19 ADV 64 THE TAKEAWAY ® FEBRUARY 2015 ∕ DERMATOLOGYTIMES.COM ALTERANTIVES: Deciding when to employ alternative therapies with patients from page 57 for Complementary and Alternative Medicine. So I felt like I was brought into the cutting edge at that point. DR. SIEGFRIED: I think it’s nice to mention that David Eisenberg was the first western-trained medical student to have a foreign exchange with China right after Nixon opened relations in the early 1970s. He wrote a wonderful book called “Adventures with Chi” for anyone that’s interested. What year did you have the opportunity to work with him? A Dr. Lio: That would have been the summer of 1998. And, once I finished medical school, I did my preliminary year of dermatology residency in pediatrics at Boston Children’s Hospital, which also shaped me greatly. They recognized my interest in complementary medicine and any time there was a patient interested in alternatives or perhaps something that was a little out of the ordinary, they would call me in. When I finished training, I heard about a course offered through Harvard called Structural Acupuncture for Physicians. I think it’s now hosted by Brigham and Women’s Hospital in Boston. Once you complete it, you get enough CME hours to be able to practice acupuncture as a physician in almost every state, and you have both the theoretical foundation as well as some practical experience to do so. DR. SIEGFRIED: How do you decide which patient’s conditions are more well-suited to a form of alternative therapy? A Dr. Lio: One of the things I try to do is really listen to and read the patient. My general default is going to be Western medicine. My training is in Western medicine; so if a patient doesn’t say anything, that is how I’ll approach treatment. But if a patient says he doesn’t My general default is going to be Western medicine. ... But if a patient says he doesn’t really want topical steroids or antibiotics, for example, then I talk about what other options we have. Peter Lio, M.D. really want topical steroids or antibiotics, for example, then I talk about what other options we have. I am honest and upfront about the idea that we’re really trying to pick the best treatments that have the best evidence. So even if it seems alternative, it has at least some evidence. There are a lot of treatments we use and we don’t really understand why they work, but we have enough data; and then the opposite is also true. If I feel like the alternative is not going to help them, I’m going to tell the patient that I think he’s wasting his time. That’s how I try to manage expectations. DR. SIEGFRIED: Are there any conditions for which you gravitate toward a homeopathic or alternative approach? Dr. Lio: My area of interest and my passion is atopic dermatitis. I think it’s really well-suited for this in a lot of ways. I think many of those patients, in particular, are curious about or have tried al- Dermatology Times (Print: ISSN 0196-6197, Digital ISSN 2150-6523) is published monthly by UBM Advanstar, 131 W. First St., Duluth, MN 558022065. Subscription rates: $95 for one year in the United States and Possessions; $140 for one year in Canada and Mexico; all other countries, $185 for one year. International pricing includes air-expedited service. Single copies (prepaid only): $10 in the United States, $15 in Canada and Mexico, $20 all other countries. Back issues, if available, are $20 in the United States and Possessions, $30 in Canada and Mexico, and $40 in all other countries. Include $ 6.50 per order plus $2 for additional copy for U.S. postage and handling.If shipping outside the United States, include an additional $10 per order plus $3 per additional copy. Periodicals postage paid at Duluth, MN 55806 and additional mailing offces. POSTMASTER: Please send address changes to DERMATOLOGY TIMES, c/o PO Box 6013, Duluth, MN 55806-6013. Canadian G.S.T. number: R-124213133RT001.Publications Mail Agreement Number 40612608. Return undeliverable Canadian addresses to IMEX Global Solutions, P.O. Box 25542, London, ON, N6C 6B2,Canada. Printed in the U.S.A. ©2015 Advanstar Communications Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by Advanstar Communications Inc. for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, magenta cyan yellow black DR. SIEGFRIED: In general, what percentage of patients employ some alternative approach? Chicago A ternative therapies, and so that’s a great place to experiment. We’re going to use them much more as complimentary therapies — meaning things that will be supporting our more conventional approaches. So even if you’re recommending a fairly mainstream treatment plan, patients love that there can be some natural or herbal components playing a role. Other diseases I think are much harder. For example, I find that with acne I really don’t have great luck with some of the alternatives. We have a couple of things we keep in our back pocket, but the data on them is not so great and our regular treatments are so good that you have to be really motivated not to want to use regular treatments. A Dr. Lio: Over half of my patients are trying it, interested, or come to me asking about it. I have created an eczema center called The Chicago Integrative Eczema Center. We have a free meeting every other month. We have families come on a Saturday morning and we talk really in depth about eczema, and we focus on or emphasize some of the alternative treatments. That’s been a big success. While we see some of those folks as patients, we have a lot of people coming from all over the country for the weekend just for the information. We usually have speakers from different areas of alternative medicine come and lecture to the doctors and the patients who attend. That’s another place that I feel like I get to keep learning from practitioners who are really in the field seeing patients. DT Next month: Dr. Lio considers the pros and cons of specific alternative therapies in dermatology. 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. fax 440-756-5255 or email: [email protected]. UBM Advanstar provides certain customer contact data (such as customer’s name, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. 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ES557008_DT0215_064.pgs 01.22.2015 00:35 ADV IMPORTANT INFORMATION ABOUT SOOLANTRA® (ivermectin) Cream, 1% BRIEF SUMMARY This summary contains important information about SOOLANTRA (soo lan’ trah) Cream. Read this information carefully before you prescribe SOOLANTRA Cream. For full Prescribing Information and Patient Information please see the package insert. WHAT IS SOOLANTRA CREAM? SOOLANTRA Cream is a topical prescription medicine indicated for the treatment of the inflammatory lesions of rosacea. WHO IS SOOLANTRA CREAM FOR? SOOLANTRA Cream is indicated for people with inflammatory lesions of rosacea. It is not known if SOOLANTRA Cream is safe and effective for children. Advise your patients to not use SOOLANTRA Cream for a condition for which it was not prescribed and remind them to not give SOOLANTRA Cream to other people, even if they have the same symptoms as it may harm them. WHAT SHOULD I ASK MY PATIENTS BEFORE PRESCRIBING SOOLANTRA CREAM? Before you prescribe SOOLANTRA Cream, ask your patients if they: • have any other medical conditions. • are pregnant or planning to become pregnant. It is not known if SOOLANTRA Cream can harm an unborn baby. • are breastfeeding or plan to breastfeed. It is not known if SOOLANTRA Cream passes into breast milk and if it can harm a baby. SOOLANTRA Cream is supplied in a child-resistant capped tube. • To open, gently press down on the child resistant cap and twist counterclockwise. To avoid spilling, do not squeeze the tube while opening or closing. • To close, gently press down on the child resistant cap and twist clockwise. WHAT ARE THE INGREDIENTS IN SOOLANTRA CREAM? Active ingredient: ivermectin. Inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. WHERE SHOULD I GO FOR MORE INFORMATION ABOUT SOOLANTRA CREAM? • This Brief Summary summarizes the most important information about SOOLANTRA Cream. For full Prescribing Information and Patient Information please see the package insert. • Go to www.soolantra.com or call 1-866-735-4137 Trademarks are the property of their respective owners. GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Revised: December 2014 WHAT ARE THE MOST COMMON SIDE EFFECTS OF SOOLANTRA CREAM? The most commonly reported side effects when using SOOLANTRA Cream include skin burning sensation and skin irritation. Remind your patients to tell you if they have any side effect that bothers them or that does not go away. These are not all of the possible side effects of SOOLANTRA Cream. For more information, see the full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA LABORATORIES, L.P. AT 1-866-735-4137. HOW SHOULD PATIENTS USE SOOLANTRA CREAM? • SOOLANTRA Cream is for use on the face only and should not be used in the eyes, mouth, or vagina. • SOOLANTRA Cream should be applied to the affected areas of the face once a day. APPLYING SOOLANTRA CREAM: • A pea-sized amount of SOOLANTRA Cream should be applied to each area of the face (forehead, chin, nose, each cheek) that is affected. Avoid contact with the lips and eyes. References: 1. Stein Gold L, Kircik L, Fowler J, et al; Ivermectin Phase III Study Group. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316-323. 2. Data on file. Galderma Laboratories, L.P. 3. Taieb A, Ortonne JP, Ruzicka T, et al; Ivermectin Phase III Study Group. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol. In press. All trademarks are the property of their respective owners. ©2015 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway, Fort Worth, TX 76177 IVM-143B Printed in USA 02/15 magenta cyan yellow black ES555369_DT0215_CV3_FP.pgs 01.17.2015 01:24 ADV TREATING INFLAMMATORY LESIONS OF ROSACEA CAN BE TOUGH… INTRODUCING A TOUGH TOPICAL NEW SOOLANTRA® (ivermectin) CREAM, 1%—POWERFUL AND RAPID RESULTS FROM A ONCE-DAILY TOPICAL1,2*† • –20.5 (–64.9%) mean inflammatory lesion count reduction at week 122*† • Better efficacy from once-daily Soolantra Cream, 1% vs twice-daily metronidazole 0.75% cream as early as 3 weeks3‡ • Specifically formulated for patients with inflammatory lesions of rosacea—Cetaphil® Moisturizing Cream was the basis for the vehicle2 w w w.so o l a n t r a. c o m /hc p Important Safety Information Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Adverse Events: In clinical trials with SOOLANTRA® Cream, 1% the most common adverse reactions (incidence ≤1%) included skin-burning sensation and skin irritation. Warnings/Precautions: Not for oral, ophthalmic, or intravaginal use. 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. Please see brief summary of Prescribing Information on adjacent page. * The efficacy and safety of SOOLANTRA® Cream, 1% once daily was evaluated in subjects aged ≥18 years in 2 identically designed phase 3 clinical trials (N=1371). Final results were comparable between the 2 studies, with the least favorable results presented here. † A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of SOOLANTRA® Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (Investigator Global Assessment [IGA] score of 3 or 4). ‡ An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA® Cream, 1% once daily with metronidazole 0.75% cream twice daily in 962 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period. magenta cyan yellow black ES555370_DT0215_CV4_FP.pgs 01.17.2015 01:24 ADV