Wearable technology meets dermatology

Transcription

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.
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®
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
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
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
| THE TAKEAWAY | PETER LIO, M.D., discusses considering treatment plans using alternative medicine. SEE PAGE 57
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ES557023_DT0215_003.pgs 01.22.2015 00:37
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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
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ES555300_DT0215_004_FP.pgs 01.17.2015 00:13
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◆
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
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ES555299_DT0215_005_FP.pgs 01.17.2015 00:13
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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)
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ES555296_DT0215_006_FP.pgs 01.17.2015 00:13
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ES556507_DT0215_007.pgs 01.21.2015 01:37
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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.
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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.
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ES555291_DT0215_009_FP.pgs 01.17.2015 00:12
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10
LEGAL
®
EAGLE
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
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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
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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
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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-
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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
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www.CeraVe.com
ES557425_DT0215_013_FP.pgs 01.22.2015 04:21
ADV
14
CLINICAL DERMATOLOGY
®
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
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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.
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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
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-
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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
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18
CLINICAL
DERMATOLOGY
®
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.
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
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▶ 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
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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
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ES555442_DT0215_INSERT1_FP.pgs 01.17.2015 03:30
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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
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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.
of rosacea, part 5: a guide on the management
of rosacea. Cutis. 2014;93(3):134–138.
of rosacea, part 2: a status report on topical
agents. Cutis. 2013;92(6):277–284.
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
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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
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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
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22
COSMETIC DERMATOLOGY
®
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
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ES556490_DT0215_022.pgs 01.21.2015 01:33
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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
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ES555294_DT0215_023_FP.pgs 01.17.2015 00:13
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,
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
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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-
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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
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26
COSMETIC
DERMATOLOGY
®
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
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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
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28
COSMETIC
DERMATOLOGY
®
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
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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.
• 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.
®
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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%)
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ES542910_DT0115_TARO2_FP.pgs 12.11.2014 15:32
ADV
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.
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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
®
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
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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.
• 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
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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
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CUTANEOUS ONCOLOGY
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
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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
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36
CUTANEOUS
ONCOLOGY
®
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
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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
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38
CUTANEOUS
ONCOLOGY
®
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.
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“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
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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.
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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
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42
BUSINESS OF DERMATOLOGY
®
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
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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
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ES555417_DT0215_043_FP.pgs 01.17.2015 01:26
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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.
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.
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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
as follows:
NDC 99207-467-30
Bottle of 30
green, unscored, coated, and debossed
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.
pink, unscored, coated, and debossed
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
cardiac function, and concomitant disease contains minocycline hydrochloride
conclusion on causal association can
or other drug therapy.
be established.
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
3 times and 2 times, respectively, the
hemodialysis or peritoneal dialysis.
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46
BUSINESS
OF DERMATOLOGY
®
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-
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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
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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
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48
BUSINESS
OF DERMATOLOGY
®
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
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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,
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Download the app now:
dermatologytimes.com/gomobile
iPad is a registered trademark of Apple Inc.
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ES555387_DT0215_049_FP.pgs 01.17.2015 01:25
ADV
50
BUSINESS
OF DERMATOLOGY
®
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?
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➧ 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
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electronic brachytherapy (eBx®) contact [email protected]
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1
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©2015 Xoft, a subsidiary of iCAD, Inc. All rights reserved. Axxent, Xoft and Electronic Brachytherapy System (eBx) are registered trademarks of iCAD, Inc.
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ES555420_DT0215_051_FP.pgs 01.17.2015 01:27
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52
BUSINESS
OF DERMATOLOGY
®
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.”
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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
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ES555403_DT0215_053_FP.pgs 01.17.2015 01:25
ADV
54
TRADE TOOLS
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
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ES557349_DT0215_054.pgs 01.22.2015 02:44
ADV
CALENDAR/ AD INDEX
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
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13
RETIN-A MICRO
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39 - 40
SOLODYN
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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
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innovative
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[email protected] | +1.973.276.0336
ES557018_DT0215_055.pgs 01.22.2015 00:37
ADV
The 11th Annual
ded
d
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Jus
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ES555374_DT0215_056_FP.pgs 01.17.2015 01:24
ADV
®
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
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ES557009_DT0215_057.pgs 01.22.2015 00:35
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58
Dermatology Times |
Products & Services
SHOWCASE
Go to:
February 2015
products.modernmedicine.com
EDUCATION
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Closure Course and Dermatologic Surgery:
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May 20-21, 2015 – Closure Course
This intense learning experience provides didactic instruction and practical
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featured in Dermatologic Surgery: Focus on Skin Cancer (below), without direct
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November 4, 2015 – Basal and Squamous Cell Cancer Pathology for Mohs Surgeons
Taught by Board-certified dermatopathologists, this intense one-day course will
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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
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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
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For additional information, please contact:
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EDUCATION
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Alastair Carruthers, FRCPC
Directors:
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ES556154_DT0215_058_CL.pgs 01.20.2015 21:19
ADV
February 2015
|
59
Go to:
Products & Services
SHOWCASE
EDUCATION
PRODUCTS
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COMPANY NAME
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marketers, fnd out more at:
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PRODUCTS & SERVICES
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Call Karen Gerome
to place your Showcase ad at
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ES556172_DT0215_059_CL.pgs 01.20.2015 21:20
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60
Dermatology Times |
Products & Services
SHOWCASE
Go to:
February 2015
SERVICES
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ES556156_DT0215_060_CL.pgs 01.20.2015 21:19
ADV
February 2015
|
Marketplace
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OTC PRODUCTS
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Long established busy medical and surgical
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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.
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
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
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DISTRICT OF COLUMBIA
WASHINGTON, DC
Associate Opportunity
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
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
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!
www.MyDermGroup.com
ES556155_DT0215_062_CL.pgs 01.20.2015 21:19
ADV
February 2015
|
Marketplace
63
CAREERS
NORTH CAROLINA
PENNSYLVANIA
Tampa, FLORIDa
HICKORY, NC
www.MyDermGroup.com
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
www.MyDermGroup.com
State of the art 12,000 sq. ft. facility with
SANFORD, NC
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
www.MyDermGroup.com
Tulsa, Oklahoma
NEW MEXICO
SANTA FE, NEW MEXICO
Partnership available. Established practice
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].
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For further information contact:
Edward H. Yob, DO at
[email protected] or
call 918-307-0215
OREGON
UTAH
BOUNTIFUL, UTAH
Associate Opportunity
www.MyDermGroup.com
RECRUITMENT
ADVERTISING
Can Work For You!
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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
®
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
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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
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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.
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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
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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
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.
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ES555370_DT0215_CV4_FP.pgs 01.17.2015 01:24
ADV

Wearable technology meets dermatology

Transcription

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