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Dermatology Times®
Clinical Analysis for Today’s Skincare Specialists
July 2016 | VOL. 37, NO. 7 |
July 2016
A new take on
AK treatment
In This Issue
CLINICAL 14
Energy-based treatments for acne
Expert sheds light on the role two devices
play in new era for acne treatment
COSMETIC 33
Botox for millennials?
Volume 37 No. 7
Refined therapies improve outcomes
shared some innovative refinements of conventional AK treatments.
Dr. Martin, who is a solo practitioner at Dr.
George Martin Dermatology Associates of Maui,
Kihei, Hawaii, says “Clearly, singular lesions are
best and most conveniently treated with liquid
nitrogen. However, the presence of a single AK
can be deceiving in terms of the true scope of
Ilya Petrou, M.D. | Senior Staff Correspondent
Actinic Keratosis (AK) is a chronic disease that can manifest in single or multiple
lesions, including subclinical lesions that are
invisible to the naked eye. In Hawaii, where
the sun shines all year long, dermatologists
are no strangers to patients with AK. Speaking at Maui Derm 2016, George Martin, M.D.,
A
Tips for understanding and treating a
younger aesthetic demographic
AK see page 54
B
ONCOLOGY 53
New genetic insight for UV
Protein-coding gene established as key
player in UV-induced DNA damage repair
BUSINESS 56
Meaningful use
Evolving regulations may signal the end
of onorous meaningful use requirements
C
Patient shown
at baseline (A);
at the end of
a one-week
treatment
regimen in which
the patient
applied 3.75%
imiquimod daily
for one week
(B); and finally
at two years of
once weekly
3.75% imiquimod
treatments (C).
Photo:
George Martin, M.D.
DermatologyTimes.com
Psoriasis oral pipeline lacks options
While the need for therapeutic innovation exists, so do bright spots
John Jesitus | Staff Correspondent
Oral treatment for moderate-to-severe
psoriasis has not kept pace with biologic
therapies, despite the recent FDA approval
of apremilast (Otezla, Celgene). There is a
need for safe, effective long-term oral psoriasis therapies, researchers wrote in their
review, published June 2015 in the Journal
Expert Opinion on Emerging Drugs.
There is an important place, however, for
oral treatments like apremilast in the care of
psoriasis patients, according to Joel Schlessinger, M.D., president of LovelySkin.com and
a dermatologist practicing in Omaha, Neb.
“Apremilast has become a useful alternative for patients who either aren’t willing or
aren’t able to use the injectable new forms of
treatment for psoriasis or are not topical treatment candidates,” Dr. Schlessinger says.
Two bright spots on the oral pipeline horizon, according to the dermatologist, include medications with fumaric acid, which
has been used successfully in Europe to treat
psoriasis patients, as well as Janus kinase, or
JAK, inhibitors.
“JAK inhibitors are also an exciting area of
potential exploration in not only the treatment
of psoriasis but also alopecia areata, and many
other conditions,” Dr. Schlessinger says. “Generally speaking, the benefits of injectables that
are available are superior to oral treatments
that are available but that doesn’t mean that
oral treatment isn’t respected. It just means
that many patients will try injectables before
PSORIASIS see page 24
JULY 2016 ⁄ DERMATOLOGYTIMES.COM
EDITORIAL ADVISORY BOARD
Insight & Opinion From Our Advisory Board Leaders
Elaine C. Siegfried, M.D.,
is professor of pediatrics
and dermatology,
Saint Louis University Health
Sciences Center, St. Louis, Mo.
Progress for women in medicine slow, but significant
y childhood was guided by Donna Reed and June Cleaver, but
I came of age under the influence of Gloria Steinem and Betty
Friedan, when women were clamoring for change. By the time I
completed my training, almost half of my professional colleagues
were female. So I am impatiently annoyed that in the year 2016 women have
not been as equally represented among the leaders in our field.
M
But change is never easy or fast. From
a historic perspective, it’s been only
about a half-dozen generations since
women were even allowed to train in medicine (initially at a segregated institution). Opportunities for leadership have been
even more recent. In 2016, 57% of college students are female but only 23% of
all bachelor’s and master’s level institutions employ female presidents. That figure is higher for community colleges and
Ivy League universities.1 Women also continue to lag behind men as lead authors in
top medical journals, although those numbers are improving.2
PROFESSIONAL ORGANIZATIONS
The American Dermatological Association (ADA) is dermatology’s founding, and
most enduring, specialty-specific organization. The ADA was established by 16
men in 1876, and membership has always
been by peer-nomination. In 1925, a few
years after Dr. Rose Hirschler became the
first female U.S. dermatologist,4 an ADA
vote allowed women to attend their historical lectures and dinner.
It was another quarter-century before
Dr. Beatrice Kesten, who clearly deserved
the recognition, became the first female
ADA inductee.5
The American Board of Dermatology
(ABD) was established in 1932 as a founding member of the American Board of
Medical Specialties. Dr. Kesten became
the first female director in 1953. The organization did not elect another woman until
Dr. Barbara Gilchrest became a director in 1988. As of 2015, only ten of the 100
emeritus directors were women. However,
the current ABD leadership includes eight
women and 11 men.
The American Academy of Dermatology (AAD) was founded in 1937 by 17
“founding fathers.” The inaugural meeting was held November 1938 in my hometown, St. Louis, Mo., and was attended
by approximately 40% of the nearly 600
members.6 The AAD now represents
more than 19,000 fellows; almost half
are women. As of 1970, only one woman
served on the AAD Board of Directors
(Dr. June Carol Shafer, 1956-1958). The
second, Dr. Margaret Ann Storkan, was
elected in 1971 and became vice president two years later, when less than 10%
of the more than 4,000 AAD members
were women. During the next two decades, women made few leaderships inroads, despite support from male colleagues like Dr. Walter Shelly, who reportedly nominated several women to committees, but was often declined.3
It was not until 1992 that Dr. Wilma
Bergfeld took office as the first woman
president, after serving on the Board of
Directors for 10 years. Since then, the
AAD has been led by additional female
presidents, vice presidents, secretary/
treasurers, and board directors. The AAD
also honors outstanding members as well
as non-dermatologists, including a small
minority of women: one of the 10 Distinguished Service Award recipients, one of
the first 10 Gold Medal honorees, five of
the 30 Master Dermatologists and two of
the 26 Marion Sulzberger winners.7
Men have dominated the political
world in almost all cultures. In 2016, 89%
of the countries in the world are led by
men. The dermatology academic political
microcosm is similar. Among those who
chair academic departments of Dermatology, I counted 17 women among the
117 programs listed by the AAMC.8 Notably progressive locations are my “Show
Me” state, where all three departments
are chaired by women, and Massachusetts, with three of four programs being
led by women. And two programs are
chaired by a second generation female
(Eastern Virginia and Boston University).
A forum held at the annual AAD meeting focused on “Closing the Gender Gap in
Academic Dermatology and Dermatology
Leadership: Problems and Solutions.” It included all-women faculty presentations on
work-life balance, navigating the two career
household, negotiating skills, and mentoring. It did not tackle the delicate and complex topic of pay discrepancy, which is
greater for professionals.
Is lack of female leadership the result of
institutional sexism, or of women’s personal
choice and skill set? Males and females
have evolved over millennia to embrace different roles. Physical strength, a characteristically male trait, trumped all other leadership qualities until technological advances
allowed appreciation of alternate leadership
skills. So, as Dr. Walter Shelly noted,3 other
female characteristics must be impacting
our eligibility. One may be motivation to sit
at the male-dominant table. I know of few
women who aspire to climb to the top of
an administrative bureaucracy or to build a
large corporation. But technology has allowed growing interest and inquiry about
the differences between male and female
leadership, including advantageous feminine characteristics: compassion, organization, honesty, collaboration, task focus,
and interest in mentoring.
Change is slow, but steady. Many
women have already achieved notable
firsts: flying solo across the Atlantic, winning a Nobel Prize, and serving as mayors, senators and Prime Ministers. And
one day a woman will be elected President of the United States. DT
References online:
bit.ly/WomenInDerm
7
8
EDITORIAL ADVISORY
®
BOARD
The Dermatology Times Editorial Advisory Board
qualifies the editorial content of the magazine.
Members review meeting programs; suggest story
topics, special reports and sources; evaluate
manuscripts; conduct interviews and roundtables;
and counsel editors as questions arise.
content
Sara Michael
VP, CONTENT & STRATEGY
Teresa A. McNulty
GROUP CONTENT DIRECTOR
Heather Onorati
CONTENT CHANNEL DIRECTOR
[email protected] | (440) 826-2868
Pamela Kreigh
CONTENT MANAGING EDITOR
Eliza Cabana
AESTHETIC CONTENT EDITOR
Zoe Diana Draelos, M.D.
COSMETIC COLUMNIST
Zoe Diana Draelos, M.D.,
Norman Levine, M.D.,
Ronald G. Wheeland, M.D.,
Elaine Siegfried, M.D.,
is consulting professor
is a private practitioner
is a private practitioner
is professor of pediatrics
of dermatologyust e,
in Tucson, Ariz.
in Tucson, Ariz.
& dermatology, Saint Louis
Duke University School
University Health Sciences
of Medicine, Durham, N.C.
Center, St. Louis, Mo.
Patricia Farris, M.D.
Reena Rupani Goyal, M.D.
Sarah Kasprowicz, M.D.
Peter Lio, M.D.
Daniel Siegel, M.D.
IRREGULAR BORDER COLUMNISTS
Jeremy Green, M.D.
Joely Kaufman, M.D.
LASER & LIGHT DEVICES COLUMNIST
David J. Goldberg, M.D., J.D.
LEGAL AFFAIRS COLUMNIST
Nancy Bitteker
DIRECTOR, DESIGN & DIGITAL PRODUCTION
Lecia Landis
ART DIRECTOR
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SENIOR PRODUCTION MANAGER
Dr. Seth
Dr. Ranella
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Dr. Roy
Dr. Patti
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Matarasso
Hirsch
Goldberg
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Farris
Alster
New York, N.Y.
New York, N.Y.
New Orleans, La.
Washington D.C.
San Francisco, Calif. Boston, Mass.
sales & marketing
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EVP, MANAGING DIRECTOR
Ken Sylvia
VP, GROUP PUBLISHER
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PUBLISHER
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Aesthetic technologies
Image appears with permission from VisualDx and Logical Images Inc.
10
®
TEST YOURSELF:
bit.ly/July2016Quiz
bit.ly/AestheticTechnology
Rosacea research and treatment
WHAT’S YOUR DIAGNOSIS?
A 40-YEAR-OLD FARMER in southern Florida visited the emergency
room concerned about a plaque with ulcer on his arm that developed
along the lymphatics shortly after a small wound he received on the
farm. He was very worried when it looked like another lesion was
beginning to form.
CHOOSE ONE:
Cellulitis
New World cutaneous leishmaniasis
Nocardiosis
Atypical mycobacterial infection
Texas tops best cities for skin
Texas tops the list of
best cities for your
skin, with El Paso, San
Antonio and Austin
coming in at one, two
and three; while Florida
ranks low as having
among the worst cities
for your skin, including
the worst of the worst,
Port St. Lucie. This and
more can be found on
WalletHub’s analysis
comparing 150 of
the largest American
cities: 2016 Best &
Worst Cities for Your
Skin. The authors
scored cities according
to 17 key metrics,
including “melanoma
incidence rate per
100,000 residents,”
“ultraviolet index” and
“number of days with
extreme temperatures,”
and “number of
dermatologists.”
bit.ly/roscearesourcenter
Therapeutic considerations
for psoriasis
bit.ly/considerationsforpsoriasis
Acne Treatment and Compliance
bit.ly/texasbestforskin
bit.ly/acnetreatmentandcompliance
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)
Placebo
(N=506)
n (%)
OTEZLA 30 mg BID
(N=920)
n (%)
Diarrhea
32 (6)
160 (17)
Nausea
35 (7)
155 (17)
Upper respiratory tract infection
31 (6)
84 (9)
Tension headache
21 (4)
75 (8)
Preferred Term
Headache
19 (4)
55 (6)
Abdominal pain*
11 (2)
39 (4)
Vomiting
8 (2)
35 (4)
Fatigue
9 (2)
29 (3)
(continued)
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: Apremilast
pharmacokinetics were characterized in subjects with mild, moderate, and
severe renal impairment as defined by a creatinine clearance of 60-89, 30-59,
and less than 30 mL per minute, respectively, by the Cockcroft–Gault equation.
While no dose adjustment is needed in patients with mild or moderate renal
impairment, the dose of OTEZLA should be reduced to 30 mg once daily in
patients with severe renal impairment [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.
Manufactured for: Celgene Corporation, Summit, NJ 07901
OTEZLA® is a registered trademark of Celgene Corporation.
Pat. http://www.celgene.com/therapies
©2015 Celgene Corporation, All Rights Reserved.
Based on APRPI.005
OTZ_PsO_HCP_BSv.004 12_2015
IRREGULAR BORDER
Reena Rupani, M.D.
Center for Health and Healing
Mount Sinai Beth Israel
Does evidence support alternative
therapies for seborrheic dermatitis?
hinking back to medical school basics, we learned of several “-rrheas”: Rhinorrhea (mucous),
diarrhea (gastrointestinal waste), galactorrhea (milk). All relate to an abnormal corporeal
discharge — certainly uninvited, undesired. So along comes “seborrhea,” our dermatologic
term for an excess of sebum, a word often used synonymously with seborrheic dermatitis, but, in
fact, not quite capturing the extent of the latter’s pathophysiology. We would be hard-pressed to
convince our patients with red, flaky patches — those who complain of chronically dry skin that
emollients do not seem to help — that really, their problem is oiliness. Instead, we expand upon that
definition to include Malassezia yeast, and an inflammatory reaction to its presence on the skin.
T
While many conventional therapies are
available (-azole antifungals, low potency
steroid creams, topical non-steroidal antiinflammatories) patients are increasingly
distressed by the idea of a chronic condition, and are looking for a “root-cause”
approach to its elimination. Others are
hoping for more natural treatment options,
with less risk for long-term side effects —
hence, the growing interest in integrative
solutions.
ESSENTIAL OILS
Tea tree and borage are two topical
essential oils that have historic use and
study data related to seborrheic dermatitis. Satchell and colleagues linked the
antimicrobial action of tea tree oil to the
terpinen-4-ol molecule, and further demonstrated in a randomized controlled trial
that daily use of a 5% shampoo yielded
a 41% improvement in symptoms, as
opposed to 11% in the placebo arm.1
Borage seed oil is high in gammalinolenic acid (GLA), purported to have
anti-inflammatory benefits. However, the
data is mixed on this. One study of infantile
seborrheic dermatitis demonstrated 100%
resolution within two weeks of topical borage oil application,2 but a follow-up study
by the same group failed to demonstrate
clinical benefit.3 Of similar interest: Green
tea shows promise in skin treatments.
ALOE VERA
Aloe, that spiky succulent with tenticular
outgrowths, is an incredibly complex
plant. Aloe vera extract differs in chemical
composition based on soil and environmental climate, and contains numerous
active compounds: salicylic acid, zinc,
potassium, calcium, magnesium, and cholesterol, to name a few. It has antifungal
and wound healing properties, with folk
medicinal applications ranging from burns
to frostbite. In limited studies for seborrheic dermatitis, it has been shown to help
with associated scalp oiliness and hair
loss.4,5 In any case — it certainly can’t hurt,
and tastes good to boot.
venous administration of biotin yielded
clinical benefit on seborrheic dermatitis,
although, admittedly, with lack of a control arm.6
Similarly, infants who were fed diets
rich in egg yolks and liver, which are both
rich in biotin, in the first few months of life
experienced improvement in seborrheic
dermatitis symptoms, purportedly due to
an increase in long-chain fatty acid synthesis.7
But, the times they are a-changing. We
would be hard pressed today to find pediatricians endorsing an early diet of liver
and eggs, let alone parents interested in
IV infusions to ameliorate cradle cap to
confirm this data.
HOMEOPATHY
While many
conventional
therapies are
available, patients
are increasingly
distressed by the
idea of a chronic
condition, and are
looking for a “rootcause” approach
to its elimination.
SUPPLEMENTS
Biotin is often recommended for patients
with hair loss or nail fragility, with mixed
data to support its use, but anecdotal
benefits at higher doses. In a similar vein,
this metabolic coenzyme may have its
place in the therapeutic armamentarium
for seborrheic dermatitis. In several studies of infants back in the 1970s, intra-
Homeopathy, Samuel Hahnemann’s
200-year-old alternative medical system,
is based on the principles of “like cures
like” and “law of minimum dose”. This is
the notion that a disease can be cured by
a substance that produces similar symptoms in healthy people coupled with the
idea that the lower the dose of the medication, the greater its effectiveness.
While this remains a highly debated and
controversial system, with inconsistent
results and limited scientific data to support its use, many patients incorporate
elements of homeopathy into their medical care. Smith and colleagues conducted a
randomized, placebo-controlled, doubleblinded study utilizing a homeopathic
mixture of oral potassium bromide,
sodium bromide, nickel sulfate and
sodium chloride for the treatment of seborrheic dermatitis.
The study group achieved significant
improvement vis-à-vis the placebo group
at p<0.02.8 Such data is difficult to reproduce and standardize, however.
DIET TRENDS
Following a “yeast-free diet” is the new
trend, and while there is no strong evidence
IRREGULAR BORDER see page 65
13
14
CLINICAL
®
DERMATOLOGY
1% SHOWS PROMISE
29 IVERMECTIN
Patients may experience longer remission
from papulopustular rosacea
FACIAL BALANCE
30 ACHIEVING
Aesthetic treatments can create dramatic
improvements for Bell’s palsy patients
Energy-based treatments
offer advantages for acne
Two novel approaches may expand the therapeutic role of devices
CHERYL GUTTMAN KRADER
QUICK READ
SENIOR STAFF CORRESPONDENT
Mild-to-moderate inflammatory
acne vulgaris may benefit
from short-pulse lasers. One
expert addresses the role
these devices may play.
Laser- and light-based treatments
for acne have a long history of use and
address the desire for interventions that
can overcome the problems of poor patient compliance with topical therapies
and side effects accompanying systemic
medications. In addition, the energybased approaches are relatively easy to
perform, safe, and effective, at least compared with sham treatment. Predictability, however, has been an ongoing issue.
Two novel energy-based approaches,
one that was approved for the treatment
of mild-to-moderate inflammatory acne
vulgaris in 2012, and the other that is now
being investigated in an
FDA clinical trial in the
United States, are generating excitement about
the potential to expand
the role for energy-based
device treatment of acne,
Dr. Goldberg
says David J. Goldberg,
M.D., J.D., director, Skin Laser & Surgery
Specialists of NY/NJ, New York, NY.
Dr.Goldbergdiscussedthesemodalities
at the South Beach Symposium (Miami
Beach, Fla., February 2016).
“We are on the cusp of an exciting new
era in the treatment of acne,” he says. The
approach that is already available uses a
650-microsecond 1064-nm Nd:YAG laser
(LightPod Neo, Aerolase). Dr. Goldberg
notes that Nd:YAG laser treatment for acne
is not new. The near infrared light emitted by these devices targets water in the
sebaceous gland and causes a decrease in
gland size and function through heating.
The previously used Nd:YAG systems,
however, have a pulse duration in the millisecond range. Compared with those
devices, the short-pulse laser produces
Quotable
much less heat and that makes the treatment much more comfortable.
“The microsecond Nd:YAG laser allows treatment to be performed in all skin
types without the need for cooling or anesthesia,” says Dr. Goldberg, who is also
director, Laser Research, Icahn School of
Medicine at Mount Sinai, New York, NY.
Also in contrast to the millisecond
Nd:YAG lasers, the new microsecond device is thought to act by multiple mechanisms. Like the millisecond Nd:YAG lasers, it is thought to decrease sebaceous
gland activity via a photothermal effect.
This technology may also decrease blood
supply to the gland through selective photothermolysis of vessels and eradicate P.
acnes via a phototoxic or bactericidal effect.
As another benefit, the gentleness of
the shorter pulse duration allows stacking of multiple pulses for better penetration to deeper pustules or cysts that are
present in patients with moderate and
severe forms of acne, says Dr. Goldberg
The microsecond Nd:YAG laser is also
ACNE see page 17
DTExtra
It’s not about how they look
tomorrow or a week from
now, but five or 10 years
down the road.”
Hilary Baldwin, M.D.
Morristown, N.J.
On the importance of encouraging
patients to stay the course with tx
See story page 29
The SPLASH (Sequencing of Psoralen
Linked And Selected Hybrids) technique,
recently developed in by a team in Singapore,
shines light on the ways that RNA works
within cells. Addressing the RNA network in
cells, including shapes, translation and decay,
the SPLASH technique opens channels
for studying infectious organisms
such as dengue and Zika, opening new
possibilities for prevention and treatment.
SOURCE: BIT.LY/222NV5A
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to use
JUBLIA safely and effectively. See full prescribing information for JUBLIA.
JUBLIA® (efinaconazole) topical solution, 10%
For topical use
Initial U.S. Approval: 2014
JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated
for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton
rubrum and Trichophyton mentagrophytes.
DOSAGE AND ADMINISTRATION
Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated
flow-through brush applicator. When applying JUBLIA, ensure the toenail, the
toenail folds, toenail bed, hyponychium, and the undersurface of the toenail
plate, are completely covered.
JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.
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 directly
compared to rates in the clinical trials of another drug and may not reflect the
rates observed in practice.
In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least
24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of
treatment and in at least 1% of subjects treated with JUBLIA and those reported
in subjects treated with the vehicle are presented in Table 1.
Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated
for up to 48 Weeks
Adverse Event, n (%)
JUBLIA
N = 1227
Vehicle
N = 413
Ingrown toenail
28 (2.3%)
3 (0.7%)
Application site dermatitis
27 (2.2%)
1 (0.2%)
Application site vesicles
20 (1.6%)
0 (0.0%)
Application site pain
13 (1.1%)
1 (0.2%)
DRUG INTERACTIONS
In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither
inhibits nor induces cytochrome P450 (CYP450) enzymes.
Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered
during the period of organogenesis (gestational days 6-19) to pregnant female
rabbits. In the presence of maternal toxicity, there was no embryofetal toxicity or
malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).
In a pre- and post-natal development study in rats, subcutaneous doses of
1, 5 and 25 mg/kg/day efinaconazole were administered from the beginning of
organogenesis (gestation day 6) through the end of lactation (lactation day 20). In
the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup
mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at
25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (17 times the MRHD
based on AUC comparisons). No effects on postnatal development were noted at
25 mg/kg/day (89 times the MRHD based on AUC comparisons).
Nursing Mothers
It is not known whether efinaconazole is excreted in human milk. After repeated
subcutaneous administration, efinaconazole was detected in milk of nursing rats.
Because many drugs are excreted in human milk, caution should be exercised
when JUBLIA is administered to nursing women.
Pediatric Use
Safety and effectiveness of JUBLIA in pediatric subjects have not been established.
Geriatric Use
Of the total number of subjects in clinical trials of JUBLIA, 11.3% were
65 and over, while none were 75 and over. No overall differences in safety and
effectiveness were observed between these subjects and younger subjects, and
other reported clinical experience has not identified differences in responses
between the elderly and the younger subjects, but greater sensitivity of some
older individuals cannot be ruled out.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
A 2-year dermal carcinogenicity study in mice was conducted with daily topical
administration of 3%, 10% and 30% efinaconazole solution. Severe irritation was
noted at the treatment site in all dose groups, which was attributed to the vehicle
and confounded the interpretation of skin effects by efinaconazole. The high dose
group was terminated at week 34 due to severe skin reactions. No drug-related
neoplasms were noted at doses up to 10% efinaconazole solution (248 times the
MRHD based on AUC comparisons).
Efinaconazole revealed no evidence of mutagenic or clastogenic potential based
on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster
lung cell chromosome aberration assay) and one in vivo genotoxicity test (mouse
peripheral reticulocyte micronucleus assay).
No effects on fertility were observed in male and female rats that were
administered subcutaneous doses up to 25 mg/kg/day efinaconazole (279 times
the MRHD based on AUC comparisons) prior to and during early pregnancy.
Efinaconazole delayed the estrous cycle in females at 25 mg/kg/day but not at
5 mg/kg/day (56 times MRHD based on AUC comparisons).
PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information).
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies with JUBLIA in pregnant
women. JUBLIA should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Systemic embryofetal development studies were conducted in rats and
rabbits. Subcutaneous doses of 2, 10 and 50 mg/kg/day efinaconazole were
administered during the period of organogenesis (gestational days 6-16) to
pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity
(increased embryofetal deaths, decreased number of live fetuses, and placental
effects) was noted at 50 mg/kg/day [559 times the Maximum Recommended
Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons]. No
embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based
on AUC comparisons). No malformations were observed at 50 mg/kg/day
(559 times the MRHD based on AUC comparisons).
Manufactured for:
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
Manufactured by:
Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan
Product of Japan
U.S. Patents 8,039,494; 7,214,506
Based on 9391902
DM/JUB/15/0076 Issued: 02/2015
CLINICAL DERMATOLOGY
Combination therapy
for leishmaniasis shows promise
Laser resurfacing followed by topical paromomycin successful against recalcitrant lesion
KAREN DONLEY-HAYES | STAFF CORRESPONDENT
Anyone who keeps in touch with current topics knows the news has been rife
with reports of the spread of illnesses beyond their indigenous home geographies.
With global travel what it is, plenty of bad
players can hitch a ride to all points across
the world when travelers return home.
While the Zika virus has dominated
headlines recently, it certainly is not the
first condition to infect people and globetrot to geographies where it’s infrequently
seen. It’s easy to lose sight of the other bad
players in the arena — those conditions
are plenty important to the patients whom
they afflict.
Leishmaniasis, a single-celled parasite,
is one such condition. Cutaneous leishmaniasis is native to parts of the tropics,
subtropics, southern Europe, and parts
of Asia and Africa, where the tiny vector
— the phlebotomite sandfly — reigns.
However, those infected with the para-
QUICK READ
As tropical diseases piggyback to the
United States with travelers, the armamentarium for treating them expands.
site can experience tenacious symptoms
long after they’ve vacated the offending
bug’s homeland.
Treatment options are limited. Pentavalent antimony therapy is considered
a first line of therapy for leishmaniasis infections, and thermotherapy is a second
line. Miltefosine (Impavido, Profunda),
an oral medication that interferes with
parasite membrane protein kinase signaling, has been used to treat the condition
internationally for many years, but has
only recently been approved for use in the
United States. And, while it’s as much as
90% effective, it is not a benign treatment
— it carries a pregnancy category X black
box warning. Its use in women of childbearing age must be carefully planned,
administered, and monitored.
A STUBBORN CASE, RESOLVED
Another recent development was described in a research paper published
in the December 2015 issue of Lasers
in Surgery and Medicine, the official
publication of the American Society
for Laser Medicine and Surgery. The
study suggests that a new combination
treatment modality could join the arsenal against the disease. The manuscript, titled, “Ablative fractional laser
resurfacing with topical paromomycin
as adjuvant treatment for a recalcitrant
cutaneous leishmaniasis wound,” documents a successful case study.
The patient, who had acquired the
condition while traveling in Israel, responded well to a six-week course of
oral fluconazole with topical paromomycin, with all but one of her lesions
healing.
The recalcitrant lesion was subsequently treated with ablative microLEISHMANIASIS see page 26
ACNE:
Laser-induced photothermolysis on the horizon from page 14
less expensive for physicians and patients
because it requires no disposables.
ON THE HORIZON
Laser-induced photothermolysis of
sebaceous glands with metallic microparticles is still under investigation
as a treatment for acne, and it is being
developed by two different companies,
one using gold microparticles (Sebacia)
and the other silver (Sienna). The treatment using gold is being investigated
in a United States clinical trial in which
Dr. Goldberg is participating as an investigator.
The metallic microparticles, which
are inert, serve as an exogenous chromophore. They are applied topically in a suspension formulation, and after allowing
for penetration into the sebaceous unit,
excess suspension is wiped from the surface of the skin.
When the gold or silver microparticles
are exposed to optical pulses of a laser or
light source emitting along the absorption
curve used for laser hair removal, electron
oscillation occurs with subsequent production of heat that leads to destruction
of the proximal sebaceous unit.
“Efficacy data are still limited, but available information suggests this approach
provides more consistent responses than
previous light and laser modalities, and
the explanation may be more selective
targeting of the sebaceous unit,” Dr. Goldberg says.
“In addition, because light absorption
occurs selectively in the follicle and not
in the epidermis and dermis, the microparticle-based treatment is comfortable and avoids collateral tissue or epidermal damage.”
A study conducted in Poland by
Paithankar and colleagues enrolling
48 patients using the gold microparticles found that the treatment was well
tolerated.1 They reported a 61% average
reduction in inflammatory lesions at 28
weeks after a single treatment performed
with two passes.
The same investigators treated a second cohort of 51 patients with a series of
three treatments performed at two-week
intervals and achieved a 53% reduction
in inflammatory lesions at 16 weeks postbaseline.1 DT
Disclosures: Dr. Goldberg has research grants from
both Sebacia and Sienna Labs.
REFERENCE
1. Paithankar DY, Sakamoto FH, Farinelli WA, Kositratna
G, Blomgren RD, Meyer TJ, et al. Acne treatment based
on selective photothermolysis of sebaceous follicles
with topically delivered light-absorbing gold microparticles. J Invest Dermatol. 2015;135(7):1727-1734.
17
Minimize the unwanted risks from endocrine
effects by mitigating the risk factors favoring
increased systemic bioavailability and by using
the product as recommended [see Dosage
and Administration].
Rx Only
BRIEF SUMMARY OF PRESCRIBING
INFORMATION
SERNIVO Spray is indicated for the treatment
of mild to moderate plaque psoriasis in
patients 18 years of age or older.
DOSAGE AND ADMINISTRATION
Apply SERNIVO Spray to the affected skin
areas twice daily and rub in gently.
Use SERNIVO Spray for up to 4 weeks of
treatment. Treatment beyond 4 weeks is
not recommended.
Avoid use on the face, scalp, axilla, groin, or
other intertriginous areas.
SERNIVO Spray is for topical use only. It is not
for oral, ophthalmic, or intravaginal use.
CONTRAINDICATIONS
None.
Hypothalamic-Pituitary-Adrenal (HPA) Axis
Suppression and Other Unwanted Systemic
Glucocorticoid Effects
SERNIVO Spray can produce reversible
hypothalamic-pituitary-adrenal (HPA)
axis suppression with the potential for
glucocorticosteroid insufficiency. This may
occur during or after withdrawal of treatment.
Factors that predispose to HPA axis
suppression include the use of high-potency
corticosteroids, 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 study including 48 evaluable subjects 18
years of age or older with moderate to severe
plaque psoriasis, abnormal ACTH stimulation
test results suggestive of adrenal suppression
were identified in 5 out of 24 (20.8%) subjects
after treatment with SERNIVO Spray twice
daily for 15 days. No subject (0 out of 24) had
abnormal ACTH stimulation test results after
treatment with SERNIVO Spray twice daily for
29 days [see Clinical Pharmacology].
If HPA axis suppression is documented,
gradually withdraw the drug, reduce the
frequency of application, or substitute with
a less potent corticosteroid. If signs and
symptoms of steroid withdrawal occur,
supplemental systemic corticosteroids may
be required.
Systemic effects of topical corticosteroids
may also manifest as Cushing’s syndrome,
hyperglycemia, and glucosuria. These events
are rare and generally occur after prolonged
exposure to larger than recommended
doses, particularly with 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 SERNIVO
Spray is not recommended in pediatric
patients [see Use in Specific Populations].
Allergic Contact Dermatitis
Allergic contact dermatitis with corticosteroids
is usually diagnosed by observing failure to
heal rather than noting a clinical exacerbation.
Corroborate such an observation with
appropriate diagnostic patch testing. If irritation
develops, discontinue the topical corticosteroid
and institute appropriate therapy.
ADVERSE REACTIONS
Because clinical trials are conducted under
widely varying conditions, adverse reaction
rates observed in the clinical trials of a drug
cannot be directly compared to rates in the
clinical trials of another drug and may not
reflect the rates observed in clinical practice.
In two randomized, multicenter, prospective
vehicle-controlled clinical trials, subjects with
moderate plaque psoriasis of the body applied
SERNIVO Spray or vehicle spray twice daily
for 4 weeks. A total of 352 subjects applied
SERNIVO Spray and 180 subjects applied
vehicle spray.
Adverse reactions that occurred in at least 1%
of subjects treated with SERNIVO Spray for
up to 28 days are presented in Table 1.
Table 1: Adverse Reactions Occurring in *1%
of Subjects Treated with SERNIVO Spray for
up to Four Weeks
SERNIVO
Spray b.i.d.
(N=352)
Vehicle
Spray b.i.d
(N=180)
Application site
pruritus
6.0%
9.4%
Application site
burning and/or
stinging
4.5%
10.0%
Application site pain
2.3%
3.9%
Application site
atrophy
1.1%
1.7%
Less common adverse reactions (with
occurrence lower than 1% but higher than
0.1%) in subjects treated with SERNIVO spray
were application site reactions including
telangiectasia, dermatitis, discoloration,
folliculitis and skin rash, in addition to
dysgeusia and hyperglycemia. These adverse
reactions were not observed in subjects
treated with vehicle.
Postmarketing Experience
Because adverse reactions are reported
voluntarily from a population of uncertain
size, it is not always possible to reliably
estimate their frequency or establish a causal
relationship to drug exposure.
Postmarketing reports for local adverse
reactions to topical corticosteroids have
also included striae, irritation, dryness,
acneiform eruptions, hypopigmentation,
perioral dermatitis, allergic contact dermatitis,
secondary infection, hypertrichosis, and miliaria.
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled
studies in pregnant women. SERNIVO Spray
should be used during pregnancy only if the
potential benefit justifies the potential risk to
the fetus.
Betamethasone dipropionate has been shown
to be teratogenic in rabbits when given by the
intramuscular route at doses of 0.05 mg/kg.
The abnormalities observed included umbilical
hernias, cephalocele, and cleft palate.
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 topical administration of
corticosteroids can 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 SERNIVO Spray is administered to a
nursing woman.
Pediatric Use
Safety and effectiveness of SERNIVO 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 greater risk
of systemic toxicity, including HPA axis
suppression and adrenal insufficiency, when
treated with topical drugs. [see Warnings
and Precautions]
Rare systemic effects 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 skin atrophy
have also been reported with use of topical
corticosteroids in pediatric patients.
Geriatric Use
Clinical studies of SERNIVO Spray did not
include sufficient numbers of subjects who
were 65 years of age or older to determine
whether they respond differently from
younger subjects.
Manufactured by: DPT Laboratories, Ltd.,
San Antonio, TX 78215
Distributed by: Promius Pharma, LLC.,
Princeton, NJ 08540
Sernivo is a trademark of
Promius Pharma, LLC.
Issued: 02/2016
Isotretinoin: Time to reconsider blood tests?
Physicians are questioning the merit of routinely monitoring for health risks
RANDY DOTINGA | STAFF CORRESPONDENT
Isotretinoin (Accutane) revolutionized the world of acne treatment
when it appeared in the 1980s. More
than three decades later, it remains a
mainstay in the United States despite
continuing fears about miscarriages
and birth defects. At the same time,
it remains a hassle for many patients.
In addition to enduring common
side effects like dr yness, patients
often must follow up with regular, ongoing blood tests. And, not all dermatologists consider the tests to be
necessary.
Skepticism about testing is mounting. In the January 2016 issue of JAMA
Dermatology, a meta-analysis questions the need for monthly tests.1
“We hope this study is an opportunity for providers to change their approaches to isotretinoin monitoring,”
says study co-author Joslyn S. Kirby,
M.D., M.Ed., M.S., associate professor, Pennsylvania State University,
University Park, Pa.
HEALTH RISK REALITIES
At issue: Does isotretinoin really pose a
risk to health that can be monitored via
blood tests? Dermatologists assumed
there was a risk when the drug first appeared on the market. Indeed, “there
are clear associations between systemic retinoids (synthetic vitamin A,
including isotretinoin) and hepatitis,
hypertriglyceridemia, and leukopenia,”
says Arash Mostaghimi, M.D., M.P.A.,
M.P.H., instructor in dermatology and
internal medicine, Harvard Medical
School, Boston, Mass.
“While these are class effects, the
data, specifically for isotretinoin,
are limited. The goal of testing was
to monitor for these unlikely but potentially serious side effects,” Dr.
Mostaghimi says.
But g u idel i nes for mon itor i ng
aren’t clear. “The package insert recommends baseline fasting lipids and
hepatic panels with repeated testing
at weekly or biweekly intervals until
‘the response has been established,’”
Dr. Kirby says. “There are no specific
recommendations for monitoring of
blood counts.”
QUICK READ
While oral isotretinoin has
been associated with various
side effects and routine blood
tests have been recommended,
evidence points to inconsistencies
in monitoring practices. Many
physicians also are questioning
whether the effort has value.
Indeed, Dr. Kirby says the inspiration for the study came from her encounters with varying approaches to
labs for isotretinoin patients.
Discussing her reasoning to design
and pursue the study, Dr. Kirby says,
“I performed tests monthly, earlier in
my career, because the people around
me were doing the same thing. After
moving to Penn State, people around
me were testing less frequently based
on their accumulated experience,” she
says. “This highlighted the effect of
local practice on my decisions and the
variability in practice patterns among
groups, and it prompted me to look for
high-level evidence to guide my decisions. I developed this study based on
what I found.”
HARD DATA
The researchers evaluated data from
61 studies and included 26 of them in
the meta-analysis. The mean (99% CI)
values during treatment were:
➧ 119.98 mg/dL (98.58-141.39 mg/dL)
for triglycerides, which puts them in
the “normal” range.
➧ 184.74 mg/dL (178.17-191.31 mg/dL)
for total cholesterol, which puts it in
the “desirable” range; 109.23 mg/dL
(103.68-114.79 mg/dL) for low-density
lipoprotein (LDL) cholesterol; 42.80
mg/dL (39.84-45.76 mg/dL) for highdensity lipoprotein (HDL) cholesterol.
The LDL (“bad cholesterol”) level is
“near optimal/above optimal,” and
the HDL (“good cholesterol”) level is
just above the “low” level that’s considered risky.
➧ The levels were 2.67 U/L (19.94-25.41
U/L) for aspartate aminotransferase;
21.77 U/L (18.96-24.59 U/L) for alanine
aminotransferase; 88.35 U/L (58.94117.76 U/L) for alkaline phosphatase;
and 6890/μL (5700/μL-8030/μL) for
white blood cell count.
Overall, the meta-analysis linked
isotretinoin to statistically significant
changes in the values of lipid, white
blood cell count and liver panels.
However, the researchers say the
levels don’t put patients at high risk,
and few patients overall had abnormal
lab findings. As a result, the researchers say, the meta-analysis doesn’t support routine monthly lab tests for the
standard patient. Seth J. Orlow, M.D., Ph.D., professor and chair of dermatology, NYU
School Medicine, New York, N.Y., says
the message of the study is clear: “The
frequency and particularly the severity of abnormalities like liver function
elevations, blood count changes and
lipid levels seen in the average patient
on isotretinoin do not warrant routine
frequent testing.” He cautions, however, that monthly pregnancy testing
is still essential for women who could
bear children.
Eliminat ing t he rout ine blood
tests in most patients could bring
other benefits in addition to monetary savings.
“Some patients understand testing to check for a potential problem to
mean there is a high likelihood of that
problem and perceive that, for example, isotretinoin is a particularly liver
toxic drug,” Dr. Orlow says.
In addition, “many patients are
afraid of having blood work and this can
dissuade them from using otherwise
effective therapy,” says Harvard’s Dr.
Mostaghimi.
But he caut ions t hat t he tests
shouldn’t be abandoned entirely.
“If you have a patient who is at
higher risk or has previously had problems with similar drugs, then more
thorough testing may still be appropriate,” he says. “Given that the likelihood of all serious side effects is low,
continued research that identifies genetic variations or biomarkers that
can differentiate those at high risk will
be valuable in guiding our approach
moving forward.” DT
[1] Lee YH, Scharnitz TP, Muscat J, Chen A, Guptaelera G, Kirby JS. Laboratory Monitoring During
Isotretinoin Therapy for Acne: A Systematic Review and
Meta-analysis. JAMA Dermatol. 2016;152(1):35-44.
21
24
CLINICAL
®
DERMATOLOGY
PSORIASIS:
Price is a challenge from page 1
they try apremilast, and the apremilast
is generally used in situations where the
psoriasis isn’t quite as prevalent or PASI
score is lower than necessary for injectables to be approved or if there are some
other health conditions that are important to avoid injectables,” he says.
PRICE CHALLENGES
The big problem with the existing psoriasis treatments, including oral therapies,
is price, according to Dr. Schlessinger.
“Price has been extraordinarily challenging for many insurers and most if not
all patients. The existence of patient assistance programs has been a challenge
because to some degree of the interplay
between insurance companies and pharmaceutical companies,” he says. “Oral
treatment is modestly less expensive
than the injectable treatments, with a
significant decrease in efficacy in comparison. We have tried to get several people on the oral treatments with minimal
success. The limitations for many insurance companies are affecting our patients’ access.”
PIPELINE LINEUP
While there isn’t much public information on oral psoriasis drugs in the pipeline, the National Psoriasis Foundation
lists about 10 orals for psoriasis in phase
2 or phase 3 trials.
They are:
Prurisol (Cellceutix) is a small molecule that acts through immune modulation and PRINS (psoriasis associated
RNA induced by stress) reduction and
which is over-expressed in psoriasis. The
drug has completed a phase 2 FDA trial
under the U.S. Food and Drug Administration’s 505(b)(2) pathway. The placebocontrolled, randomized, double-blind
trial tested efficacy and safety of three
separate, twice-daily, dosing regimens:
50 milligram (mg) (50mg QD), 100mg
(50mg BD), and 200mg (100mg BD).
QUICK READ
Dermatology Times explores oral
drugs in the pipeline for psoriasis.
At the end of the 84-day treatment period, 35% of patients in the 200-mg arm
demonstrated clinically significant
improvements compared with 16.7% in
the placebo only group, according to the
recent press release. The primary endpoint was the percent of patients who
achieved at least a two-point improvement from baseline on the IGA 5-point
scale as measured by visual inspection
of patient lesions at the end of treatment period. Further analysis showed
the greatest efficacy was in patients with
moderate disease (IGA 3), according to
the company. Only one Serious Adverse
Event was reported in the 50-mg arm.
Additional Adverse Events were reported
similarly across each dosing arm and the
placebo arm, the company notes.
XP23829 (Dr. Reddy’s Laboratory), in
phase 2 research, is an anti-inflammatory (fumaric acid), according to Psoriasis.org. In a March 28, 2016 press release,
Dr. Reddy’s Laboratories and XenoPort
announced the companies had a U.S.
Licensing Agreement for XP23829, in
which Dr. Reddy’s Laboratories has exclusive U.S. rights for XP23829 development and commercialization. Plans are
to develop XP23829 as a treatment for
moderate-to-severe chronic plaque psoriasis. Discovered by XenoPort, XP23829
is an oral fumaric acid ester compound
that is a prodrug of monomethyl fumarate (MMF). Mark Jackson, M.D., clinical professor of medicine, dermatology,
University of Louisville, was quoted in
the release as saying that fumaric acid
esters feature a unique anti-inflammatory mechanism of action and have been
used to treat psoriasis in Germany for
more than 20 years. “XP23829, a novel
fumaric acid ester, has the potential to
be a meaningful treatment option for
“Oral treatment is modestly less expensive
than the injectable treatments,
with a significant decrease in
efficacy in comparison.”
Joel Schlessinger, M.D.
Omaha, Neb.
Oral treatment for
moderate to severe
psoriasis has not
kept pace with
biologic therapies,
despite the recent
FDA approval of
apremilast. There
is a need for
safe, effective
long-term oral
psoriasis therapies.
patients with moderate-to-severe psoriasis,” Dr. Jackson says.
KD025 (Kadmon Corporation), is an
orally bioavailable, potent and highly
selective inhibitor of ROCK2 (Rho-associated coiled-coiled kinase 2, in phase
2 research, according to company information. Kadmon announced January
6, 2015 that it started a phase 2 clinical
trial evaluating KD025 in moderate-tosevere psoriasis vulgaris patients who
had failed first-line therapy. The openlabel, dose-finding study is looking at
KD025 administered at doses of 200
mg twice daily and 400 mg once daily
for three months in 24 patients at six U.S.
sites. The company’s phase 2a single-arm
safety study showed positive changes in
inflammatory markers, including a specific decrease in the secretion of the proinflammatory cytokine IL-17. In the same
phase 2a study, three of the eight patients
showed a decrease in Psoriasis Area and
Severity Index (PASI) scores of up to 66%
after one month of treatment, according
to the release. “Therapies targeting IL-17
have shown significant efficacy in treating psoriasis,” Mark G. Lebwohl, M.D.,
professor and chair of dermatology at the
Icahn School of Medicine at Mount Sinai
and primary investigator of Study 206,
said in the press release. “KD025 represents a novel oral approach to treating
PSORIASIS see page 26
26
CLINICAL
®
DERMATOLOGY
PSORIASIS:
Bright spots on the horizon from page 24
psoriasis by blocking IL-17 secretion
while concurrently increasing the suppressive function of regulatory T-cells
(Treg), helping to resolve inflammation
with a minimal effect on the rest of the
immune response.”
Alitretinoin (9-cis-retinoic acid; Stiefel,
a GSK company) is indicated for psoriasis (pustular). It is a skin cell inhibitor (a
retinoid) in phase 2 research, according to
psoriasis.org. Alitretinoin is FDA approved
for the treatment of skin sores and lesions
in patients with AIDS-related Kaposi sarcoma. The study Efficacy of Alitretinoin
Treatment in Patients With Pustular Form
of Psoriasis has been completed but no
results posted on ClinicalTrials.gov. Alitretinoin is thought to have promise for patientswithpalmoplantarpustularpsoriasis
recalcitrant to conventional therapies, according to an article in the June 2015 Cutis.
Apo805k1 (ApoPharma) has an undisclosed mechanism of action. Authors
of an article in the July 2015 Cutis, write a
phase 2 randomized, placebo-controlled,
double-blind trial on Apo805k1 on moderate to severe psoriasis is complete. Twelve
patients in each treatment group received
a 12-week daily dosing regimen of 10, 30, 60
or 100 mg or placebo. Among the results:
16.7% patients in the 10-mg and placebo
groups achieved a PASI 75. There were no
patients achieving PASI 75 in the 30-mg
and 60-mg groups. And 8.3% of those in the
100-mg group achieved PASI 75, according
to the Cutis article by Feely MA, Smith BL
and Weinberg JM.
FP187 (Forward-Pharma) is an antiinflammatory (fumaric acid). FP187 is
based on the small molecule dimethylfumarate (DMF) in a patented controlled
release erosion matrix tablet with enteric
coating, according to company information. The development of FP187 benefits
with a long term track record of DMF
Two bright areas in the oral pipeline
include medications with fumaric acid,
which has been used successfully in
Europe to treat psoriasis patients, as well
as Janus kinase, or JAK, inhibitors.
in Germany, where a DMF formulation
combined with three salts of monoethylfumarate was approved for psoriasis in
1994 and has gained first-line status and
endorsement in German and international
guidelines, according to Forward Pharma.
ClinicalTrials.gov has posted for the “Efficacy Study on Dimethyl Fumarate to Treat
Moderate to Severe Plaque Psoriasis,” a
multicenter, randomized, double-dummy,
Fumaderm and placebo-controlled, parallel-group study to compare the efficacy
and safety of 500 mg of FP187 (250 mg twice
daily) compared to 720 mg Fumaderm
(240 mg three times daily) over 20 weeks
of treatment. The phase 3 study has not
yet opened for participant recruitment,
according to the government website.
LEO 22811 (LEO Pharma) is an antiinflammatory oral with a proprietary
mechanism, in phase 2 trials, according
to Psoriasis.org. LEO 22811 is among a new
generation of highly selective p38 inhibitors under development, according to LEO
Pharma literature.
Baricitinib (Eli Lilly/Incyte), an antiinflammatory (JAK1 and JAK2 inhibitor)
in phase 2 trials, is the only once-daily oral
selective JAK1 and JAK2 inhibitor in latestage clinical studies for inflammatory and
autoimmune diseases. In phase 3 studies
for rheumatoid arthritis, baracitnib is in
ongoing phase 2 trials in psoriasis, diabetic nephropathy, atopic dermatitis and
systemic lupus erythematosus, according
to PharmaTimes Online.
ZPL-389 (Ziarco Pharma Ltd.) is a small
molecule selective histamine H4 receptor
antagonist in phase 2 research. A phase
2a proof of concept study in moderate to
severe psoriasis has begun. Results are
expected in H1 2017, according to the company’s website.
VTP-43742 (Vitae Pharmaceuticals) is
an anti-inflammatory (IL-17 blocker) in
phase 2 research. Vitae Pharmaceuticals
announced March 16, 2016 positive results
from its Phase 2a proof-of-concept clinical
trial of VTP-43742 in psoriatic patients.
VTP-43742 is a first-in-class, orally active
RORγt inhibitor, which inhibits IL-17 secretion from Th17 cells and blocks the action
of IL-23. VTP-43742 demonstrated efficacy
with patients at a dose of 350 mg — a group
of patients achieving a 24% reduction in
the Psoriasis Area Severity Index (PASI)
score relative to placebo. In the 700 mg dose
group, patients achieved a 30% placeboadjusted PASI score reduction, according
to the company. DT
Disclosure: Dr. Schlessinger was an investigator
for one of the apremilast studies.
The information cited above was the most recent
data available at press time.
REFERENCE:
Mahmood T, Zaghi D, Menter A. Emerging oral
drugs for psoriasis. Expert Opin Emerg Drugs. 2015
Jun;20(2):209-20. Epub 2015 Feb 3. Review.
LEISHMANIASIS:
Promising potential options from page 17
fractionated 10,600-nm carbon dioxide laser (Ultrapulse Encore Deep Fx,
Lumens, LTD., Yokneam, Israel) and topical paromomycin applied immediately
after the laser surgery, then continued
daily for a total of three months. The infection resolved and the lesion cleared
with minimal scarring, providing a
positive cosmetic outcome.
While this study examined only a single patient, it points to a promising potential treatment option that may be
able to help patients who have lesions
that have not responded completely
via other treatment approaches. And
that, hopefully, could help to keep leishmaniasis infections in check, even as
global travel increases the likelihood
that it won’t be keeping to its home
territory. DT
(retapamulin ointment), 1%
The following is a brief summary only; see full prescribing information
for complete product information.
1 INDICATIONS AND USAGE
ALTABAX® is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment
of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9
months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes
[see Clinical Studies (14)]. Safety in patients younger than 9 months has not been established.
4 CONTRAINDICATIONS
None.
5
8
5.1 Local Irritation
In the event of sensitization or severe local irritation from ALTABAX, usage should be discontinued, the ointment
wiped off, and appropriate alternative therapy for the infection instituted [see Patient Counseling Information (17)].
5.2 Not for Systemic or Mucosal Use
ALTABAX is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. The efficacy and
safety of ALTABAX on mucosal surfaces have not been established. Epistaxis has been reported with the use of
ALTABAX on nasal mucosa.
5.3 Potential for Microbial Overgrowth
The use of antibiotics may promote the selection of nonsusceptible organisms. Should superinfection occur
during therapy, appropriate measures should be taken.
Prescribing ALTABAX in the absence of a proven or strongly suspected bacterial infection is unlikely to provide
benefit to the patient and increases the risk of the development of drug-resistant bacteria.
6
ADVERSE REACTIONS
6.1 Clinical Studies Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical
trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect
the rates observed in practice. The adverse reaction information from the clinical trials does, however, provide a
basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The safety profile of ALTABAX was assessed in 2,115 adult and pediatric subjects 9 months and older who used
at least one dose from a 5-day, twice-a-day regimen of retapamulin ointment. Control groups included 819 adult
and pediatric subjects who used at least one dose of the active control (oral cephalexin), 172 subjects who used
an active topical comparator (not available in the US), and 71 subjects who used placebo.
Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of subjects treated with
retapamulin ointment, 6.6% (54/819) of subjects receiving cephalexin, and 2.8% (2/71) of subjects receiving
placebo. The most common drug-related adverse events (greater than or equal to 1% of subjects) were application site irritation (1.4%) in the retapamulin group, diarrhea (1.7%) in the cephalexin group, and application site
pruritus (1.4%) and application site paresthesia (1.4%) in the placebo group.
Adults
The adverse events, regardless of attribution, reported in at least 1% of adults (aged 18 years and older) who
received ALTABAX or comparator are presented in Table 1.
Table 1. Adverse Events Reported by *1% of Adult Subjects Treated with ALTABAX or Comparator in
Phase 3 Clinical Trials
ALTABAX
Cephalexin
Adverse Event
N = 1,527
N = 698
%
%
Headache
2.0
2.0
Application site irritation
1.6
<1.0
Diarrhea
1.4
2.3
Nausea
1.2
1.9
Nasopharyngitis
1.2
<1.0
Creatinine phosphokinase increased
<1.0
1.0
Pediatrics
The adverse events, regardless of attribution, reported in at least 1% of pediatric subjects aged 9 months
to 17 years who received ALTABAX are presented in Table 2.
Table 2. Adverse Events Reported by *1% in Pediatric Subjects Aged 9 Months to 17 Years Treated
with ALTABAX in Phase 3 Clinical Trials
Adverse Event
Application site pruritus
Diarrhea
Nasopharyngitis
Pruritus
Eczema
Headache
Pyrexia
7 DRUG INTERACTIONS
Coadministration of oral ketoconazole 200 mg twice daily increased retapamulin geometric mean AUC(0-24) and
Cmax by 81% after topical application of retapamulin ointment, 1% on the abraded skin of healthy adult males.
Due to low systemic exposure to retapamulin following topical application in adults and pediatric patients aged
2 years and older, dosage adjustments for retapamulin are unnecessary in these patients when coadministered
with CYP3A4 inhibitors such as ketoconazole. Based on in vitro P450 inhibition studies and the low systemic
exposure observed following topical application of ALTABAX, retapamulin is unlikely to affect the metabolism of
other P450 substrates.
Concomitant administration of retapamulin and CYP3A4 inhibitors, such as ketoconazole, has not been studied
in pediatric patients. In pediatric subjects aged 2 to 24 months, systemic exposure of retapamulin was higher
compared with subjects aged 2 years and older after topical application [see Pharmacokinetics (12.3)]. Based
on the higher exposure of retapamulin, it is not recommended to coadminister ALTABAX with strong CYP3A4
inhibitors in patients younger than 24 months.
The effect of concurrent application of ALTABAX and other topical products to the same area of skin has not
been studied.
ALTABAX
N = 588
%
1.9
1.7
1.5
1.5
1.0
1.2
1.2
Cephalexin
N = 121
%
0
5.0
1.7
1.0
0
1.7
<1.0
Placebo
N = 64
%
0
0
0
1.6
0
0
1.6
Other Adverse Events
Application site pain, erythema, and contact dermatitis were reported in less than 1% of subjects in clinical trials.
6.2 Postmarketing Experience
In addition to reports in clinical trials, the following events have been identified during postmarketing use of
ALTABAX. Because these events are reported voluntarily from a population of uncertain size, it is not possible to
reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders and Administration Site Conditions
Application site burning.
Immune System Disorders
Hypersensitivity, including angioedema.
8.1 Pregnancy
Pregnancy Category B.
Effects on embryo-fetal development were assessed in pregnant rats given 50, 150, or 450 mg per kg per day by oral
gavage on Days 6 to 17 postcoitus. Maternal toxicity (decreased body weight gain and food consumption) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) were evident at doses greater than
or equal to 150 mg per kg per day. There were no treatment-related malformations observed in fetal rats.
Retapamulin was given as a continuous intravenous infusion to pregnant rabbits at dosages of 2.4, 7.2, or
24 mg per kg per day from Day 7 to 19 of gestation. Maternal toxicity (decreased body weight gain, food
consumption, and abortions) was demonstrated at dosages greater than or equal to 7.2 mg per kg per day (8-fold
the estimated maximum achievable human exposure, based on AUC, at 7.2 mg per kg per day). There was no
treatment-related effect on embryo-fetal development.
There are no adequate and well-controlled trials in pregnant women. Because animal reproduction studies
are not always predictive of human response, ALTABAX should be used in pregnancy only when the potential
benefits outweigh the potential risk.
8.3 Nursing Mothers
It is not known whether retapamulin is excreted in human milk. Because many drugs are excreted in human milk,
caution should be exercised when ALTABAX is administered to a nursing woman. The safe use of retapamulin
during breastfeeding has not been established.
8.4 Pediatric Use
The safety and effectiveness of ALTABAX in the treatment of impetigo have been established in pediatric patients
aged 9 months to 17 years. Use of ALTABAX in pediatric patients (9 months to 17 years of age) is supported by
evidence from adequate and well-controlled trials of ALTABAX in which 588 pediatric subjects received at least
one dose of retapamulin ointment, 1% [see Adverse Reactions (6.1), Clinical Studies (14)]. The magnitude of efficacy and the safety profile of ALTABAX in pediatric subjects 9 months and older were similar to those in adults.
The safety and effectiveness of ALTABAX in pediatric patients younger than 9 months have not been established. An open-label clinical trial of topical treatment with ALTABAX (twice daily for 5 days) was conducted
in subjects aged 2 to 24 months. Plasma samples were obtained from 79 subjects. In these pediatric subjects,
systemic exposure of retapamulin was higher compared with subjects aged 2 to 17 years. Furthermore, a higher
proportion of pediatric subjects aged 2 to 9 months had measurable concentrations (greater than 0.5 ng per mL)
of retapamulin compared with subjects aged 9 to 24 months [see Pharmacokinetics (12.3)]. The highest levels
were seen in subjects aged 2 to 6 months [see Pharmacokinetics (12.3)]. The use of retapamulin is not indicated
in pediatric patients younger than 9 months.
8.5 Geriatric Use
Of the total number of subjects in the adequate and well-controlled trials of ALTABAX, 234 subjects were aged
65 years and older, of whom 114 subjects were aged 75 years and older. No overall differences in effectiveness
or safety were observed between these subjects and younger adult subjects.
10 OVERDOSAGE
Overdosage with ALTABAX has not been reported. Any signs or symptoms of overdose, either topically or by
accidental ingestion, should be treated symptomatically, consistent with good clinical practice.
There is no known antidote for overdoses of ALTABAX.
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenic potential have not been conducted with retapamulin.
Retapamulin showed no genotoxicity when evaluated in vitro for gene mutation and/or chromosomal effects in
the mouse lymphoma cell assay, in cultured human peripheral blood lymphocytes, or when evaluated in vivo in
a rat micronucleus test.
No evidence of impaired fertility was found in male or female rats given retapamulin 50, 150, or 450 mg per kg
per day orally.
17 PATIENT COUNSELING INFORMATION
Patients using ALTABAX and/or their guardians should receive the following information and instructions:
• Use ALTABAX as directed by the healthcare practitioner. As with any topical medication, patients and
caregivers should wash their hands after application if the hands are not the area for treatment.
• ALTABAX is for external use only. Do not swallow ALTABAX or use it in the eyes, on the mouth or lips,
inside the nose, or inside the female genital area.
• The treated area may be covered by a sterile bandage or gauze dressing, if desired. This may also be
helpful for infants and young children who accidentally touch or lick the lesion site. A bandage will
protect the treated area and avoid accidental transfer of ointment to the eyes or other areas.
• Use the medication for the full time recommended by the healthcare practitioner, even though symptoms may have improved.
• Notify the healthcare practitioner if there is no improvement in symptoms within 3 to 4 days after
starting use of ALTABAX.
• ALTABAX may cause reactions at the site of application of the ointment. Inform the healthcare practitioner
if the area of application worsens in irritation, redness, itching, burning, swelling, blistering, or oozing.
ALTABAX is a registered trademark of Aqua Pharmaceuticals.
Manufactured by: GlaxoSmithKline
Barnard Castle, County Durham, DL12 8DT, United Kingdom
Manufactured for: Aqua Pharmaceuticals, an Almirall Company,
Exton, PA 19341
© 2016 Aqua Pharmaceuticals. All rights reserved. November 2015
05/2016 ALT-005E
ALT-005B
ALTABAX
®
Ivermectin 1% cream
extends rosacea remission
LISETTE HILTON | STAFF CORRESPONDENT
In a relapse study, researchers report
successful initial treatment with oncedaily ivermectin 1% cream (Soolantra,
Galderma) resulted in longer remission
among patients with moderate-to-severe
papulopustular rosacea, compared with
initial treatment with twice daily metronidazole 0.75% cream.
Papulopustular rosacea remission
is known to be challenging to maintain post treatment. Patients in the two
groups studied were successfully treated
for 16 weeks with either Ivermectin 1%
cream or metronidazole 0.75% cream.
The data in the new study (Part B)
looks at a 36-week extension of the phase
3 ATTRACT (Assessment of a Topical
Treatment in Rosacea: Activity, Compliance, Tolerability) superiority study
(Part A), published in the British Journal
of Dermatology last spring.
For the new study, researchers followed rosacea patients ever y four
weeks for up to 36 weeks. Among the
findings: Median time to first relapse
was 115 days in the ivermectin 1%
group, versus 85 days in the metronidazole 0.75% arm. Relapse rates at the
end of the study were 62.7% treated
with ivermectin, versus 68.4% metronidazole. And the median number of
days free of treatment was 196 days in
the ivermectin arm, compared to 169.5
days metronidazole
Adverse events were equally low in
both arms, according to the study.
Dermatologist Hilary Baldwin, M.D.,
medical director at the Acne Treatment
and Research Center and a Galderma
consultant, tells Dermatology Times
that new data showing longer time to
relapse and more days free of medication for patients successfully treated with
once daily Soolantra Cream versus those
“I often let the patient decide between
an oral or topical treatment, given the
strong safety and efficacy profiles seen
in both Oracea and Soolantra. I find
that if the patient is part of the
decision, they tend to have
better compliance with
their medication.”
Hilary Baldwin, M.D.
Morristown, N.J.
treated with twice daily metronidazole
addresses “real world” human nature.
“Knowing that rosacea is a chronic
condition, long-term suppression of
the inflammatory process is to the benefit of the patient,” Dr. Baldwin says.
“So I always encourage my patients to
remain on their treatment, even when
their symptoms improve — reminding
them it is not about how they look tomorrow, or a week from now, but five
or 10 years down the road. However,
we know in real-world practice, patients aren’t always going to remain
compliant in drug application, especially when their symptoms are better. Based on the findings of the long
term phase 3 ATTRACT study, the benefit of using Soolantra Cream is that it
extends remission longer than metronidazole, giving patients the opportunity to take a ‘drug holiday’ from their
prescription, without necessarily losing any progress with their treatment.”
Dr. Baldwin says that she anticipated using ivermectin 1% cream as
an adjunctive therapy to Oracea (doxycycline, USP 40 mg, Galderma) for patients with severe papulopustular rosacea. However, while she often uses
Study results at a glance
Ivermectin
1% group
Metronidazole
0.75% group
115 days
85 days
Relapse rates at end of study
62.7%
68.4%
Median number days free of tx
196
169.5
Median time to first relapse
the medications together, she now also
uses Soolantra Cream as a standalone
treatment with positive results.
“Therefore, now I often let the patient decide between an oral or topical treatment, given the strong safety
and efficacy profiles seen in both Oracea and Soolantra. I find that if the patient is part of the decision, they tend
to have better compliance with their
medication,” she says.
According to Dr. Baldwin, anyone
with papulopustular rosacea is an eligible candidate for Soolantra Cream,
regardless of severity.
“Mild, moderate or severe, Soolantra works well to reduce inf lammator y lesions—though not studied i n er y t hematotela ng iec tat ic
rosacea. Patients with really sensitive
skin, or those who do not like to take
oral medications, are very good candidates for Soolantra Cream,” Dr. Baldwin says.
Dr. Baldwin says that she has not
heard any patients in her practice complain of side effects from the Soolantra cream.
“In fact, Soolantra Cream was specifically designed to be gentle on the skin,
using Cetaphil as the basis for the vehicle, which is important to rosacea patients who often have sensitive skin,”
she says. “In clinical trials, side effects
were infrequent and mild, with the most
common including skin burning sensation and skin irritation. Proper use of
any prescription treatment is critical in
managing side effects.” DT
29
30
CLINICAL
®
DERMATOLOGY
Botulinum toxin, fillers help restore
facial balance in Bell’s palsy patients
Early aesthetic interventions can minimize disfigurement and improve quality of life
Bell’s palsy, which affects about 40,000
Americans annually, is the most common
cause of facial paralysis, according to the
NationalInstituteofNeurologicalDisorders
and Stroke (NINDS). Washington, D.C.based dermatologist Cheryl M. Burgess,
M.D., says she sees many patients with
permanent facial disfigurementfromBell’spalsy,
andwithneurotoxinsand
fillers Dr. Burgess helps
to restore normal facial
balance.
Bell’s palsy is an idDr. Burgess
iopathic facial paralysis
that may be caused by a virus. Most cases
resolve within six months; however, permanent facial nerve damage can occur,
resulting in a permanent disfigurement
of the face, Dr. Burgess says. Bell’s palsy
affects men and women equally and can
occur at any age, but it is less likely to
occur before age 15 or after age 60. People
who have it often have diabetes or upper
respiratory issues, like a cold or the flu,
according to NINDS.
The condition affects one side of the
face, cosmetically. As a result, many patients request fillers for ipsilateral volume
loss, not recognizing contralateral hyperkinetic facial muscle activity, according
to Dr. Burgess.
“The impact over time causes asymmetry and disfigurement; therefore, both
sides of the face are often treated to preserve facial balance,” she says.
Dr. Burgess explains that these patients usually present with asymmetrical faces and facial expressions and occasional speech impediment.
QUICK READ
A dermatologist describes how she
uses fillers and botulinum toxin-A to
restore disfiguring facial imbalances
that result from Bell’s palsy.
The condition affects people physically, emotionally and socially.
“Many complain of dry eye on the affected side and/or drooling. Reluctance
to social interaction is common, especially when the people who knew them
when their appearance was normal,” Dr.
Burgess says.
WHAT CAN DERMS DO?
Dr. Burgess recommends that dermatologists consider assessing the contralateral side, first.
“The hyperkinetic nature of the facial muscles on the [contralateral] side
of the face can pull the paralyzed or [ipsilateral] side of the face towards it; thus,
creating a twisted appearance of the perioral region,” she says. “Relaxing the hyperkinetic muscles will create a balance
to the face.”
Dermatologists can minimize longterm distortion of the face if they intervene early on in a permanent Bell’s palsy
condition — usually one to two years
after onset, she says.
To help balance out the occasional ipsilateral facial volume loss, Dr. Burgess
uses volumizing fillers, such as polylactic acid, hyaluronic acid, calcium hydroxylapatite, or fat.
Dermatologists can use botulinum
toxin-A (generic) and Botox (Allergan),
Xeomin (Merz), and Dysport (Ipsen) to
relax the hyperkinetic muscles.
“Doses can vary depending on the de-
Many of Dr. Burgess’ patients are being
followed by their internists and/or
neurologists; however, they report that
their physicians have failed to discuss
the possible cosmetic treatment options.
gree of muscle involvement,” Dr. Burgess says.
“On the average, I use from 60 to 80 units in
one session on the [contralateral] side of the
face, where the hyperkinetic muscle contractions occur.”
Dr. Burgess might use less in a patient whose
distortion is more recent and who doesn’t have
a lot of facial distortion, she says.
Use of botulinum toxin type A for Bell’s palsy
is considered experimental and investigational
by such carriers as Aetna, according to Aetna.
com. The ICD-10 code given for facial nerve
disorders/Bell’s palsy is G51.0. According to Dr.
Burgess, the CPT code 64612, and the J code is
J0585 medical BTX-A.
Whether for acute or chronic cases, the outcomes from using botulinum type A can be
quite good. A researcher reported in 2013 in
Otology and Neurotology that use of botulinum
toxin after acute facial palsy is “of great value,”
decreasing relative hyperkinesis contralateral
to the paralysis and resulting in greater symmetric function.1
Researchers reported in Plastic and Reconstructive Surgery in May 2005, that up to 16%
of Bell’s palsy patients have significant sequelae, including tightened facial muscles,
with a deepening nasolabial fold and reduced
palpebral fissure; blepharospasm; and nerve
damage resulting in ipsilateral forehead paralysis, reduced depressor anguli oris function
and poor excursion of the angle of the mouth
on smiling.2
They found botulinum toxin’s effect in these
patients was more apparent during facial animation and not as much when the face was
static. But patients greatly appreciated the improvement in facial symmetry.
Dr. Burgess says that, in her experience,
most of her patients with Bell’s palsy are being
followed by their internists and/or neurologists; however, they report that their physicians have failed to discuss the possible cosmetic treatment options.
“Therefore, dermatologists should be
knowledgeable about treatment options to
open up a dialogue with their Bell’s palsy patients,” she says. DT
Disclosure: Dr. Burgess is a clinical investigator for Allergan and Merz and
is on the advisory board honorarium for Allergan, Galderma, and Merz.
References online:
bit.ly/aestheticforbellspalsy
Enstilar ® (calcipotriene and betamethasone dipropionate) Foam,
0.005%/0.064% for topical use
Initial U.S. Approval: 2006
BRIEF SUMMARY: Please see package insert for full Prescribing Information.
Enstilar ® (calcipotriene and betamethasone dipropionate) Foam is indicated for
the topical treatment of plaque psoriasis in patients 18 years of age and older.
CONTRAINDICATIONS
None.
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COSMETIC DERMATOLOGY
36
NUANCES FOR ASIAN PATIENTS
Asian skin has unique needs. Find out
what they are and how to treat them.
Should you use neurotoxins
on your millennial patients?
Social media, selfies and reality-TV
celebrities are among the influences
driving millennials to the cosmetic surgeon’s office for neurotoxin injections and
more, according to 2015 stats released
earlier this year by the American Academy of Facial Plastic and Reconstructive
Surgery (AAFPRS).
But the experts we interviewed say
treating younger patients with Botox
(onabotulinumtoxinA, Allergan), Dysport (abobotulinumtoxinA, Ipsen) or
Xeomin (incobotulinumtoxinA, Merz
Aesthetics) isn’t necessarily the same as
treating middle-aged and older patients.
Manolis G. Manolakakis, M.D., an
oral/maxillofacial surgeon and fellowship trained facial cosmetic surgeon in
Shrewsbury N.J., says he has noticed
the upswing in demand for botulinum
toxin treatments among patients 30 and
younger. The surgeon says he has been
treating younger patients with “subclinical” Botox, to give them a smooth — not
frozen — look.
“By relaxing the resting state of the
QUICK READ
HOW TO INJECT 30S-AND-UNDER
Millennials need safety, aesthetics,
and techniques that are geared
to their younger skin.
muscle, the skin will have smoother appearance,” he says. “Preventative Botox
is something that has been sort of a controversy. My belief is that if done properly (conservatively) on younger patients, Botox can be utilized as an antiaging modality to prevent dynamic
rhytids to turn into static rhytids, without creating a disuse atrophy.”
Washington, D.C.-based facial plastic surgeon Houtan Chaboki, M.D., says
he commonly starts Botox for women
and some men in their 20s.
“Generally, I will recommend starting with the basics: sun block/protection, hydration, gentle cleansing, no
smoking, avoid excess salt. Next, some
patients will start tretinoin topical ointment. Lastly, Botox for those who still
want to maximize their appearance.
Even young skin can benefit from Botox
(or similar wrinkle relaxers such as Dysport),” he says.
DTExtra
Simple combinations of negative facial
outlines, just like ‘emoticons’, reflect
universally understood facial expressions,
according to Christian Drehsen, M.D. Dr. Drehsen
says that her RefresherLift paradigm for facial
rejuvenation is inspired by the correction of
detrimental facial expressions and can safely
and consistently help patients restore their
self-confidence and popularity, help reverse
discrimination related to aging appearance, and
improve wellbeing.
SOURCE: CLINIQUE OF PLASTIC SURGERY, ST. PETERSBURG, FLA.
BIT.LY/EXPRESSIONGUIDEDREJUV
First, and notably, there are safety precautions to consider when treating especially younger female patients with
botulinum toxins.
“Important safet y precaut ions
include asking about pregnancy or
ensuring the patient is not breastfeeding,” says James Marotta, M.D., who
practices in Smithtown, N.Y. “Indications for treating young patients are
wrinkling at rest, muscle hypertrophy
or hyperactivity or a family history of
early rhytids.”
Dr. Manolakakis says that similar
to his evaluation of older botulinum
toxin patients, he wants to make sure
the young patients are physically and
mentally healthy before receiving injections.
“Dynamic rhytids are expected
in younger patients. I evaluate the
strength of their facial muscles [for] all
of their expressions, (frowns, smiles,
lifting of brows, etc). I also evaluate
their brow shape and position, and their
smile line,” Dr. Manolakakis says. “If a
MILLENIALS see page 34
Quotable
This procedure has
burgeoned in popularity.”
Hema Sundaram, M.D.
Washington, D.C.
Find out what the “charming roll”
is and who’s getting it.
See story page 36
33
34
COSMETIC
®
DERMATOLOGY
MILLENIALS:
Manage expectations from page 33
smile is more ‘gummy’ than what I feel
is appropriate, I will inject the alaque
nasi on either side of the nose. This will
reduce the amount of upwards pull of
the upper lip and reduce the amount of
gummy show. The lateral brow lift with
crow’s feet injection is a nice way to lift
the brow without making the lateral orbicularis muscle look frozen.”
Over-injecting younger patients can
actually make them look older, according to Dr. Manolakakis.
“A little bit goes a long way [in the
30-and-younger crowd],” Dr. Manolakakis says.
Mathew A. Plant, M.D., a plastic surgeon in Toronto, Ontario, Canada, says
he also uses lower neurotoxin doses on
young people, than older patients.
“I personally use only six units in the
forehead diluted to smooth the frontalis but not paralyze it,” Dr. Plant says.
Hollywood, Fla., dermatologist Todd
Minars, M.D., says younger people requesting Botox are often seeking prevention of lines, rather than treatment
of lines. But not every young person is a
good candidate for treatment.
“There are times where I have discouraged younger patients from beginning the procedure and encourage them to reassess in six months to
a year,” Dr. Minars says. “The biggest
‘novice injector’ mistake I see involves
the forehead. A difficult patient to treat
is the young person who has no frown
lines but does have prominent forehead
lines. The temptation is to just treat
the forehead, but that often leads to a
heavy brow, which does not look good
and does not feel good either. The patient often feels like weights are hanging from their brow.”
The solution, according to Dr. Minars,
is to balance the brow by also injecting the glabella — even if the patient’s
frown lines do not need to be treated.
“We explain to them that glabella is
necessary for balance. While the forehead injections lower the brow, the
frown line injections raise the brow,”
Dr. Minars says. “Our experience has
proven that even 10 units in the glabella
will help balance out a forehead.”
San Diego, Calif.-based plastic surgeon Robert Kearney, M.D., says he
injects under-30 patients only when
they have an animation deformity
that he believes will lead to permanent wrinkles.
“If they do not have strong muscles
that are creating creases when they animate then they are probably not yet candidates,” Dr. Kearney says.
The most common sites for botulinum toxin injections in patients
younger than 30 are the forehead and
glabella, Dr. Kearney says.
“Once injected, if they like the results they should continue the process
at regular intervals to keep the muscle
from moving,” he says. “If they like the
results, they should get regular injections (on average that would be every
three months) … for 12 to 18 months. At
that point you may be able to go every
six months as the muscle gets weaker.”
Dr. Kearney adds that any patient
who already has creases from muscle
action should get the neurotoxin, first,
and, at a second visit, get a filler to fill
in the hollows.
MANAGING MILLENNIAL EXPECTATIONS
Cosmetic physicians should not oversell expectations or outcomes, regardless of a patient’s age, according to Dr.
Manolakakis.
“Because the driving force for these
patients to come in for injections is typically someone famous or [a] reality star,
I have to remind them that these people
usually have a whole team of people who
work on their image…,” Dr. Manolakakis
says. “Although Botox works, I really try
to convey to my patients that what you
see in the media is not completely real.”
Young patients won’t see the more
dramatic effects that older patients do,
simply because young people tend not
to have wrinkles, according to Dr. Plant.
“It’s best to manage their expectations, as they probably won’t see a huge
difference …. I always ensure to suggest
a small Botox brow lift to open the eyes,
so they do see some sort of change,” Dr.
Plant says.
Not everyone believes in botulinum
toxin’s ability to preserve a youthful appearance. And if that’s the case, doctors
need to share that information with patients, according to one dermatologist.
“I only treat static rhytids in the pre30s crowd,” says dermatologist Valerie
Goldburt, M.D., Ph.D., who practices in
New York City. “Also, I tell them that it
won’t actually stop aging. It’s so important to set expectations, because they
may erroneously think it will somehow
preserve their face at that age.”
Dr. Manolakakis says that while
younger patients tend to tell him what
they want done, older patients are more
likely to ask him what he thinks they
need.
“What the younger patients need to
understand is that less is more. Even
though they know what they want, it’s
still my aesthetic [experience] that I need
to stay true to,” he says.
His policy? Dr. Manolakakis says it’s
complete honesty with his patients. He’s
honest, for example, about whether he
thinks patients should get the injections.
NEW TREATMENT OPPORTUNITIES
Botulinum toxin’s popularity in the
younger set goes beyond cosmetic facial
concerns, according to New York City plastic surgeon Leonard Grossman, M.D. In
the much younger patients, neurotoxins
are used mostly for treatment of hyperhidrosis, he says.
“Next are the patients with familial or
genetic and habitual frowning. Most of
them are after 18 years of age and they
simply don’t like looking ‘perplexed’ all
the time,” Dr. Grossman says. “Then you
have patients with very developed masseter muscles…, which create a wide
and disproportioned face. Lastly, there
is a group of young models who wish to
have thinner lower legs (calves in particular). Treating them with Botox makes
the legs appear longer and leaner.”
San Francisco-based plastic surgeon Jonathan Kaplan M.D., MPH, Pacific Heights Plastic Surgery, says that
patients younger than 30 who come in
for injectables present an interesting opportunity.
“They aren’t as worried about the
‘taboo’ of cosmetic surgery, and they’re
well-versed in social media. So these
millennials are a great way to promote
your practice,” Dr. Kaplan says. “I had a
neon sign made that offers a saying with
a double-meaning: ‘I GOT STUCK AT
PHPS’ along with a smiley face that has
the 11’s (wrinkles) in between the eyebrows! After treatment, patients take a
photo in front of the sign and post it on
their social media.” DT
36
COSMETIC
®
DERMATOLOGY
From the pages of
Nuances of Asian aesthetics
Cultural and physiologic differences affect strategy and treatment
Asian Americans are the highestincome, best-educated and fastestgrowing ethnic group in the United
States, according to a Pew Research
Center report released in 2012, called
“The Rise of Asian Americans.” When
it comes to cosmetic treatment in this
patient population, successful outcomes may depend on understanding
physiological and cultural nuances.
Washington, D.C., area dermatologist Hema Sundaram, M.D., has a
special interest in Asian aesthetics.
She is lead author of a new consensus
group publication that will be published this spring in Plastic and Reconstructive Surgery, which includes
a discussion of injectable treatments
in Asians and other ethnicities. This
article, “Global Aesthetics Consensus: Hyaluronic acid fillers and botulinum toxin type A: Recommendations for combined treatment and
special considerations to optimize
outcomes in diverse patient populations,” provides recommendations
from a notable group of dermatologists and plastic surgeons from the
U.S., Canada, Europe, Asia, Australia and Latin America. Joining Dr.
Sundaram, the North American faculty includes Drs. Jean Carruthers,
Steven Fagien, Gar y Monheit, Rod
Rohrich and Arthur Swift.
Dr. Sundaram says that dermatologists and plastic surgeons in the
United States will likely be treating
QUICK READ
Asian faces and reflecting on cultural
disparities, as well as “distinctive treatment goals,” according to consensus
recommendations by the multi-specialty Asia-Pacific Consensus Group.
Dr. Sundaram was a member of this
group, which developed consensus
increasing numbers of Asian patients.
recommendations for Asians based
“This reflects ongoing expansion
on members’ experiences using coheof the Asian population in America,
sive polydensified matrix hyaluronic
and the steady increase, year by year,
acid and calcium hydroxylapatite fillin the number of patients of color
ers. The group published its findings
who seek cosmetic procedures, as rein November 2015 in Plastic and Revealed by annual procedural surveys
constructive Surgery.
from the American Society for DerTaking that a step further, it’s immatologic Surgery, American Sociportant for cosmetic surgeons to be
ety for Aesthetic Plastic Surgery and
aware of the typical congenital baseother core aesthetic specialty orgaline for Asian patients, but also to unnizations,” she says.
derstand that Asian patients are not
Dr. Sundaram’s first recommenthe homogeneous population that
dation for cosmetic surgeons treatsome perceive them to be, according patients of all et hnicities:
ing to Dr. Sundaram.
Focus on facial harmonization,
“Ty pical Asian st rategies
Focus
rather than rejuvenation.
with injectables include inon facial
“This entails age-approharmonization, jection of filler to the medial
priate modification of conmidface, forehead and chin.
rather than
genital baseline characterFiller may also be injected to
rejuvenation
istics, together with correcthe radix and dorsum of the
tion of acquired disharmonies,
nose. Botulinum toxin neurowhich are usually age-related in our
modulator is typically injected to
patients seek ing cosmetic procethe masseters,” Dr. Sundaram says.
dures, although they can have other
G eog raph ic va r iat ions ref lec t
causes, such as injuries,” she says.
the significant differences in facial
canons and morphotypes between
‘TYPICAL’ BEAUTY STRATEGIES
Northern-type Asians, such as those
Cosmetic clinicians treating Asian pafrom Korea and Japan, and Southerntients need to distinguish among ethtype Asians, such as those from Innic populations, realizing the notable
donesia or Singapore, according to
differences between Caucasian and
Dr. Sundaram.
“For example, augmentation of the
medial midface is not required for
many Southern Asians, who already
have sufficient convexity in this facial region. However, they may have
more requirement for augmentation
of the nasal bridge and dorsum, to
correct concavities and produce a
narrowing effect,” she says. “Conversely, high doses of botulinum
toxin to the masseters may be more
appropriate for Nort hern Asians,
since their congenital baseline tends
to include a greater bimandibular
width and a more square jaw.”
Aesthetic approaches for Asian
patients must consider cultural
disparities, demographic
trends, societal ideals, and
distinctive treatment goals.
“Originally, the canons were for Caucasian
faces, but now we have some publications
for African and Afro-Caribbean faces, [as
well as] for Asian and for Indian. While
an understanding of ethnic facial
canons is certainly helpful,
we cannot get locked into
these principles.”
Hema Sundaram
Washington, D.C.
NUANCES see page 39
®
(clindamycin phosphate and tretinoin) Gel 1.2%/0.025%
The following is a brief summary only; see full prescribing information
for complete product information.
1
VELTIN® (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of
acne vulgaris in patients 12 years and older.
4
CONTRAINDICATIONS
VELTIN Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibioticassociated colitis.
5
5.1 Colitis
Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody
diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical
clindamycin. If significant diarrhea occurs, VELTIN Gel should be discontinued.
Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up
to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with
atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.
Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis.
The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be
associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for
C. difficile toxin may be helpful diagnostically.
5.2 Ultraviolet Light and Environmental Exposure
Exposure to sunlight, including sunlamps, should be avoided during the use of VELTIN Gel. Patients with
sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to
sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure
due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of
sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or
cold, also may be irritating to patients under treatment with VELTIN Gel.
6
ADVERSE REACTIONS
6.1 Adverse Reactions in Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in
clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not
reflect the rates observed in clinical practice.
The safety data reflect exposure to VELTIN Gel in 1,104 subjects with acne vulgaris. Subjects were 12
years and older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported
in *1% of subjects treated with VELTIN Gel are presented in Table 1.
Table 1. Treatment Related Adverse Reactions Reported by *1% of Subjects
VELTIN Gel Clindamycin Gel Tretinoin Gel
Vehicle Gel
N = 1,091
N = 1,104
N = 1,084
N = 552
n (%)
n (%)
n (%)
n (%)
Patients with at least one
140 (13)
38 (3)
141 (13)
17 (3)
adverse reaction
Application site dryness
64 (6)
12 (1)
62 (6)
3 (1)
Application site irritation
50 (5)
4 (<1)
57 (5)
5 (1)
Application site exfoliation
50 (5)
2 (<1)
56 (5)
2 (<1)
Application site erythema
40 (4)
6 (1)
39 (4)
3 (1)
Application site pruritus
26 (2)
7 (1)
23 (2)
6 (1)
Sunburn
11 (1)
6 (1)
7 (1)
3 (1)
Application site dermatitis
6 (1)
0 (0)
8 (1)
1 (<1)
Local skin reactions actively assessed at baseline and end of treatment with a score >0 are presented in Table 2.
Table 2. Local Skin Reactions in Subjects Treated With VELTIN Gel
VELTIN Gel
Vehicle Gel
Baseline
End of Treatment
Baseline
End of Treatment
Local Reaction
N = 476 (%)
N = 409 (%)
N = 219 (%)
N = 209 (%)
Erythema
24%
21%
31%
35%
Scaling
8%
19%
14%
12%
Dryness
11%
22%
18%
13%
Burning
8%
13%
8%
4%
Itching
17%
15%
22%
14%
During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter.
7
DRUG INTERACTIONS
7.1 Erythromycin
VELTIN Gel should not be used in combination with erythromycin-containing products due to
possible antagonism to the clindamycin component. In vitro studies have shown antagonism between these
2 antimicrobials. The clinical significance of this in vitro antagonism is not known.
7.2 Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of
other neuromuscular blocking agents. Therefore, VELTIN Gel should be used with caution in patients receiving
such agents.
8
8.1 Pregnancy
Pregnancy Category C.
There are no well-controlled studies in pregnant women treated with VELTIN Gel. VELTIN Gel should
be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A limit teratology
study performed in Sprague Dawley rats treated topically with VELTIN Gel or 0.025% tretinoin gel at a dose of
2 mL/kg during gestation days 6 to 15 did not result in teratogenic effects. Although no systemic levels of tretinoin
were detected, craniofacial and heart abnormalities were described in drug-treated groups. These abnormalities
are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100%
absorption and based on body surface area comparison. For purposes of comparison of the animal exposure to
human exposure, the recommended clinical dose is defined as 1 g of VELTIN Gel applied daily to a 50-kg person.
Clindamycin: Reproductive developmental toxicity studies performed in rats and mice using oral doses
of clindamycin up to 600 mg/kg/day (480 and 240 times the recommended clinical dose based on body surface
area comparison, respectively) or subcutaneous doses of clindamycin up to 180 mg/kg/day (140 and 70 times
the recommended clinical dose based on body surface area comparison, respectively) revealed no evidence
of teratogenicity.
Tretinoin: Oral tretinoin has been shown to be teratogenic in mice, rats, hamsters, rabbits, and primates. It
was teratogenic and fetotoxic in Wistar rats when given orally at doses greater than 1 mg/kg/day (32 times the
recommended clinical dose based on body surface area comparison). However, variations in teratogenic doses
among various strains of rats have been reported. In the cynomologous monkey, a species in which tretinoin
metabolism is closer to humans than in other species examined, fetal malformations were reported at oral
doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (324 times the recommended clinical
dose based on body surface area comparison), although increased skeletal variations were observed at all
doses. Dose-related teratogenic effects and increased abortion rates were reported in pigtail macaques.
With widespread use of any drug, a small number of birth defect reports associated temporally with the
administration of the drug would be expected by chance alone. Thirty cases of temporally associated congenital
malformations have been reported during 2 decades of clinical use of another formulation of topical tretinoin.
Although no definite pattern of teratogenicity and no causal association have been established from these
cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with
incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk
to fetus is not known.
8.3 Nursing Mothers
It is not known whether clindamycin is excreted in human milk following use of VELTIN Gel. However,
orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the
potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the drug to the mother. It is not known
whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be
exercised when VELTIN Gel is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness of VELTIN Gel in pediatric patients younger than 12 years have not been established.
Clinical trials of VELTIN Gel included 2,086 subjects aged 12 through 17 years with acne vulgaris. [See
Clinical Studies (14).]
8.5 Geriatric Use
Clinical trials of VELTIN Gel did not include sufficient numbers of subjects aged 65 and older to determine
whether they respond differently from younger subjects.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of VELTIN Gel
or the effect of VELTIN Gel on fertility. VELTIN Gel was negative for mutagenic potential when evaluated in an
in vitro Ames Salmonella reversion assay. VELTIN Gel was equivocal for clastogenic potential in the absence of
metabolic activation when tested in an in vitro chromosomal aberration assay.
Clindamycin: Once-daily dermal administration of 1% clindamycin as clindamycin phosphate in the gel
vehicle (32 mg/kg/day, 13 times the recommended clinical dose based on body surface area comparison) to mice
for up to 2 years did not produce evidence of tumorigenicity.
Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (240 times the recommended
clinical dose based on body surface area comparison) revealed no effects on fertility or mating ability.
Tretinoin: In 2 independent mouse studies where tretinoin was administered topically (0.025% or 0.1%) 3
times per week for up to 2 years no carcinogenicity was observed, with maximum effects of dermal amyloidosis.
However, in a dermal carcinogenicity study in mice, tretinoin applied at a dose of 5.1 mcg (1.4 times the
recommended clinical dose based on body surface area comparison) 3 times per week for 20 weeks acted as a
weak promoter of skin tumor formation following a single application of dimethylbenz[Į]anthracene (DMBA).
In a study in female SENCAR mice, papillomas were induced by topical exposure to DMBA followed
by promotion with 12-O-tetradecanoylphorbol-13-acetate or mezerein for up to 20 weeks. Topical application
of tretinoin prior to each application of promoting agent resulted in a reduction in the number of papillomas
per mouse. However, papillomas resistant to topical tretinoin suppression were at higher risk for
pre-malignant progression.
Tretinoin has been shown to enhance photocarcinogenicity in properly performed specific studies,
employing concurrent or intercurrent exposure to tretinoin and UV radiation. The photocarcinogenic potential of
the clindamycin tretinoin combination is unknown. Although the significance of these studies to humans is not
clear, patients should avoid exposure to sun.
The genotoxic potential of tretinoin was evaluated in an in vitro Ames Salmonella reversion test and an in
vitro chromosomal aberration assay in Chinese hamster ovary cells. Both tests were negative.
In oral fertility studies in rats treated with tretinoin, the no-observed-effect-level was 2 mg/kg/day (64
times the recommended clinical dose based on body surface area comparison).
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
Instructions for Use
• At bedtime, the face should be gently washed with a mild soap and water. After patting the skin dry,
apply VELTIN Gel as a thin layer over the entire affected area (excluding the eyes and lips).
• Patients should be advised not to use more than a pea-sized amount to cover the face and not to apply
more often than once daily (at bedtime) as this will not make for faster results and may increase irritation.
• A sunscreen should be applied every morning and reapplied over the course of the day as needed.
Patients should be advised to avoid exposure to sunlight, sunlamp, ultraviolet light, and other
medicines that may increase sensitivity to sunlight.
• Other topical products with a strong drying effect such as abrasive soaps or cleansers may cause an
increase in skin irritation with VELTIN Gel.
Skin Irritation
VELTIN Gel may cause irritation such as erythema, scaling, itching, burning, or stinging.
Colitis
In the event a patient treated with VELTIN Gel experiences severe diarrhea or gastrointestinal
discomfort, VELTIN Gel should be discontinued and a physician should be contacted.
VELTIN is a registered trademark of Aqua Pharmaceuticals.
Manufactured by: DPT Laboratories,
San Antonio, TX 78215
Manufactured for: Aqua Pharmaceuticals,
an Almirall Company, Exton, PA 19341
© 2016 Aqua Pharmaceuticals. All rights reserved.
06/2016 VEL-006B
VELTIN
COSMETIC DERMATOLOGY
NUANCES:
Society plays a large role in ideals from page 36
Arched eyebrows are not aesthetically appropriate when there is a
wider bimaxillary width, making a
straighter eyebrow more harmonizing for most Asian faces, according
to Dr. Sundaram.
“This is currently a trend for many
Caucasian faces too,” she says. Dr. Sundaram has discussed aesthetic and procedural considerations for the eyebrows
and upper eyelids in a 2013 chapter for
Clinics in Plastic Surgery.
FACIAL ANALYSIS, SOCIETAL IDEALS
Dr. Sundaram, who directs educational
and training programs focusing on Asian
aesthetics and serves on scientific boards
of conferences in Asia, says ideals and
canons of beauty have been traced thousands of years back, to the Ancient Greeks.
“Originally, the canons were for Caucasian faces, but now we have some
publications for African and Afro-Caribbean faces, [as well as] for Asian and
for Indian. While an understanding of
ethnic facial canons is certainly helpful,
we cannot get locked into these principles,” she says.
An example Dr. Sundaram gave in a
recent lecture on the topic was to show
images of two of her patients — one Caucasian and one Asian. When she asked
the audience if they saw similarities between the two, everyone said no.
“I explained that I had actually injected them with hyaluronic acid filler
in a very similar way. The reason was
that the Caucasian patient inherently
had many of the features that we see
in Asian faces. That was her congenital
baseline, or starting point,” Dr. Sundaram says. “She had a relative deficit of
medial midface volume, and a retrusion
of the chin. Therefore, an ‘Asian-type’ injection strategy was appropriate to harmonize her face.”
Facial analysis is more than individualization; it’s also an awareness of
societal ideals of beauty and cultural
overlays. An example of societal ideals
is that an Asian growing up in America
is likely to have different aesthetic ideals than an Asian patient growing up in
Asia. To illustrate the concept, Dr. Sundaram points to the “charming roll,” an
ideal which started in Korea with a celebrity who had tiny volumes of hyaluronic
acid filler injected just below the inferior
“When we inject botulinum toxin to open
the eyes, it lowers the inferior ciliary
margin by a fraction of a millimeter. But
it takes away the charming roll. So, that’s
an example of the societal influence on
cosmetic preferences, and why we need
to be well-informed about the nuances
of Asian aesthetics and having frank
dialogues with our patients.”
Hema Sundaram, M.D.
Washington, D.C.
ciliary margin, to enhance the pre-tarsal
orbicularis oculi bulge.
The aim, she says, was to give the celebrity a wider-eyed appearance.
“This procedure has burgeoned in
popularity and is now very popular with
Asian patients who have a relatively narrow palpebral fissure and absence of the
supratarsal crease,” she says. “If we inject botulinum toxin too close to the inferior ciliary margin and obliterate the
pre-tarsal bulge, this can make patients
who desire it and consider it a hallmark
of beauty very unhappy.”
On the other hand, second generation
Asians in the U.S. and other countries
may be more influenced by the ideals
of the society in which they live — even
preferring to reduce the prominence of
the pre-tarsal bulge. Similar variations
in preferences exist for contour and projection of the chin and forehead. Dr. Sundaram shares the example of a half-Japanese, half-American female patient at
her Washington, D.C., practice.
“She didn’t like her pre-tarsal bulge as
she felt it made her look tired. She wanted
her eyes opened up a bit with botulinum toxin,” Dr. Sundaram says. “When
we inject botulinum toxin to open the
eyes, it lowers the inferior ciliary margin by a fraction of a millimeter. But it
takes away the charming roll. So, that’s
an example of the societal influence on
cosmetic preferences, and why we need
to be well-informed about the nuances
of Asian aesthetics and having frank
dialogues with our patients.”
Societal ideals have far-reaching cosmetic effects. Another obvious example
of societal influences is the longstanding tendency for Asian women and some
men to want to whiten or lighten their
skin.
“They apply topicals for this purpose,
and may also sit in ‘whitening baths’ and
take oral medications for that reason. In
contrast, Asian-Americans in the US and
other Western countries don’t mind having a tan, and may even seek to enhance
their naturally tanned appearance, like
the rest of the population,” she says.
A FUNDAMENTAL TREATMENT
PRINCIPLE
As precise as Dr. Sundaram’s approaches
for treating Asian faces appear to be, she
reiterates that individual considerations
must override generalizations.
“Migration patterns in Asia over millennia have resulted in a great diversity
of facial morphotypes in many Asian
countries,” she says. “The fundamental principle that I emphasize when lecturing on and demonstrating injectables treatments for Asian patients is
that individualized treatment planning and implementation transcend
ethnic boundaries.” DT
Lisette Hilton, president of Words Come Alive, has
written about health care, the science and business of medicine, fitness and wellness for 25
years.
39
44
COSMETIC
®
DERMATOLOGY
Cosmeceuticals augment adult acne tx
Patients expect skincare guidance, dermatologists must extrapolate from limited evidence
Acne is can be a double whammy for
adults: It is unwanted and unexpected.
“The psychological impact on the
adult female is much different than the
teenager,” says Hilary E. Baldwin, M.D.,
medical director of the Acne Treatment
and Research Center in Morristown,
N.J. Adult women can be more difficult to treat because their faces are less
tolerant of irritating treatments, and
they’re more prone to inflammation
than blackheads, she adds.
“The estimate is that half of women
in their 20s and a quarter in 40s have
acne,” Dr. Baldwin says. “Once you
have it past the age of 25, it’s highly
likely you’ll have it until 45.”
Adult women are longtime veterans of cosmetics, and they often turn
to cosmeceuticals in search of acne
and rosacea relief. But there’s a big
problem: “We don’t have a lot of evidence that they can work,” says Julie
C. Harper, M.D., of the Dermatology
and Skin Care Center of Birmingham
in Alabama. “That doesn’t mean they
don’t work. We just need big studies.”
Drs. Baldwin and Harper spoke
about cosmeceuticals and their effects
on acne and rosacea at the Orlando Dermatology Aesthetic & Clinical Conference in January.
One purpose of cosmeceuticals, like
cosmetics, is to improve a person’s appearance. Like drugs, cosmeceuticals
also have some biological function. But
few studies are performed on cosmeceuticals, Dr. Baldwin says. In addition, the research that does exist tends
to be weak, perhaps enlisting only six
to eight subjects without blinding or
placebos.
QUICK READ
Adult acne patients have different
needs than their younger
counterparts, and they increasingly
turn their hopes to cosmeceuticals,
for better and for worse.
AREAS OF PROMISE
In terms of acne, Dr. Baldwin says, cosmeceuticals hold the potential — at least
hypothetically — to augment acne treatment through several mechanisms:
➧ Reducing inflammation and redness
➧ R e d u c i n g p o s t-i n f l a m m a t o r y
hyper-pigmentation
➧ Reducing greasiness
➧ Killing P. acnes
➧ Boosting sun protection
➧ Exfoliating superficial stratum
corneum
However, “the only thing that we
know for sure,” she says, “is that patients may be able to more easily use
acne medications if you repair the barrier of the skin and make it hardier.”
Moisturizers and sunscreens are
helpful and worth recommending, Dr.
Baldwin says. According to her, moisturizers and cosmeceuticals may help
acne by improving skin barriers, reducing inflammation, providing sun
protection and reducing hyperpigmentation.
“Women like to use cosmeceuticals
because they like to feel as if they’re
doing something,” she says. “They
want to be proactive about this. They’re
going to use these things anyway, so
they might as well be things that are
helpful, not harmful.”
Dr. Baldwin reminds dermatologists
that they should regularly bring up the
use of these helpful products.
“No acne visit is complete without a
The estimate is that half of women in
their 20s and a quarter in 40s have acne...
Once you have it past the age of 25, it’s
highly likely you’ll have it until 45.
Hilary E. Baldwin, M.D.
Morristown, N.J.
discussion of skincare in general, and
make sure you describe how you want
them to wash their face and dry it, and
how you want them to use sunscreen
and moisturize.”
Other cosmeceuticals can potentially have positive effects, like green
tea/black tea, witch hazel and retinol,
which may reduce greasiness, and tea
tree oil, which decreases P. acnes. AHA,
BHA and LHA, meanwhile, have exfoliating properties, while numerous botanicals may reduce inflammation.
POTENTIAL SIDE EFFECTS
On the negative side, cocoa butter, castor oil and some mineral oils can actually make acne worse, Dr. Baldwin says.
Alpha hydroxy acids can be a problem
too, because they can make acne treatments more irritating to the skin.
In terms of rosacea, Dr. Harper says,
cosmeceuticals could potentially provide benefits through sun protection,
barrier repair and anti-inflammatory,
anti-oxidant and anti-angiogenesis
properties.
In particular, vitamin B3 — niacinamide — has shown promise in strengthening the skin barrier and may be an
option for patients who can’t afford prescription medications for rosacea.
“I’ve used it more topically than orally
for rosacea,” Dr. Harper says, although
both may improve the condition.
There’s another potential benefit.
“Oral niacinamide has been shown to
decrease the development of non-melanoma skin cancer,” Dr. Harper says.
According to Dr. Harper, dermatologists should also be aware that patients
sometimes don’t realize they have rosacea and inadvertently make things
worse.
“They see bumps and they think
they have acne. They’ll pick up a product with benzoyl peroxide or salicylic
acid that can be irritating,” she says.
In the big picture, cosmeceuticals—
for better and for worse—will continue
to entice patients. “They’ll want to
know what to use,” Dr. Baldwin says,
“and expect us to have knowledge.” DT
Disclosures: Drs. Baldwin and Harper report no relevant disclosures.
46
COSMETIC
®
DERMATOLOGY
Minimize complication risk with fillers
LOUISE GAGNON | STAFF CORRESPONDENT
QUICK READ
Expert level knowledge of facial
anatomy, practice with cadaveric
dissection, proper cannula
selection, and a comprehensive
patient history are keys to
minimizing complications.
Injectors should re-acquaint themselves with facial anatomy and practice cadaveric dissection to avoid possible vascular compromise or vascular
complications associated with the injection of fillers, according to Jack Kolenda M.D., F.R.C.S.C., chief, depart“To a certain degree, everyone’s
ment of otolaryngology at the Trafalgar
anatomy is different,” he says. “The
Hospital in Oakville, Ontario, Canada.
anatomy has changed if rhinoplasty
Dr. Kolenda, an otolaryngologist
has been performed, for example, and
practicing in facial plastic surgery, ofif fillers have been injected. If fillers
fered methods to avoid complications
have been injected [in the past], pasuch as necrosis and even blindness.
tients will develop fibrosis. Some fill“The face is like a landmine,” Dr. Koers lead to more scar tissue than other
lenda told attendees at the 12th annual
fillers.”
meeting of the Canadian Association
Dr. Kolenda differentiated between
of Aesthetic Medicine (CAAM).
arterial compromise and venous com“There are some areas that are more
promise.
dangerous and others that are less dan“It is important to recognize [arterial
gerous. There is always a risk [of a comcompromise],” he says. “Patients complication]. It is remote, but you want to
plain about pain right away [with arminimize the risk.”
terial compromise]. Venous comOne of the ways to sidepromise is late presentation
step facial complications is
and will develop in tissues
Physiological and
to fine-tune your knowlover time. It is important
cultural nuances affect
edge of facial anatomy,
to have your patient leave
aesthetic outcomes in
he says. “We take anatwith an instruction sheet
the Asian population.
omy (in medical school),
and make sure you call
but it may be such a long
the patient and follow up.”
See story, page 36
time since we took it,” he
The effects of fillers can
says in an interview with
vary. Generally, with tempoDermatology Times. “We forrary fillers, an effect such as a
get how vascular the area is [that is
bruise is temporary, but “you can get
being injected]. If you can take a caa bad complication,” Dr. Kolenda says.
daveric course to remind yourself
The degree to which injection preswhere the vessels lie, that will imsure is applied also influences the risk
prove your technique. You will then
of complications, as does the speed
visualize [the vessels] when you are
with which filler is injected, he adds.
doing the injections. You will know
“The less pressure you apply, the less
what technique you should be using.
risk there is of intravascular injury,”
I really think knowledge of the anatDr. Kolenda explains. “The greater
omy and doing cadaveric dissection
the pressure you apply, the greater risk
makes you a safer injector.”
there is of intravascular injury. In addiOne unfortunate trend that Dr. Kotion, the slower you go with injection,
the better things will go (and there will
lenda has observed is seeing patients
be fewer complications).”
who have been injected with products
The onus is on the injector to prowith which he is not familiar. “Some
vide informed consent and indicate
patients are ordering products through
all possible complications that can
the internet,” he says.
occur with injecting fillers. While it
is a rare complication, blindness can
PREVIOUS TREATMENT MATTERS
It is important that healthcare professionoccur with injection of a hyaluronic
als who are injecting fillers be cognizant
acid (HA) filler. There have been 89
that previous use of fillers and surgery
documented cases of blindness reelevates the risk of complications,
ported globally in the literature reDr. Kolenda warns.
lated to injection of HA fillers.
CANNULAS NOT FOOLPROOF
Clinicians should not regard cannulas as foolproof, and should be aware
that their use can present risks as well,
particularly when thinner cannulas
are used.
“The thinner the cannulas are, the
more they behave like needles,” Dr. Kolenda says. “If you are using a thin cannula, and there is scar tissue present
and you are applying pressure to advance the cannula, you can perforate
an artery or vein. You can cause an embolic event with a cannula.”
Some zones of the face, such as the
infra-orbital area or the supra-orbital
area, are zones where it would be preferable not to use a needle when injecting filler, Dr. Kolenda says, adding that
it is advisable to use lidocaine when
injecting around the eyes.
Neurotoxin injections can precede
filler injections in the glabella and offers a means of decreasing the amount
of filler that needs to be injected, Dr.
Kolenda says. “Use a neurotoxin to
relax everything, so the amount of filler
you inject can be limited,” he advises.
When injecting a neurotoxin to treat
crow’s feet, be cautious about the zygomatus major. “Don’t go too deep (when
you inject), as this will cause a crooked
smile,” he says.
Dr. Kolenda says that, because the
arterial system is highly complex, serious side effects can occur with filler
injection. “The arterial system is interconnected just like a highway system,” says Dr. Kolenda. “In reported
cases of blindness due to filler injections, concurrent strokes have been
documented.”
Some patients experience minor
complications after filler injections,
such as cold sores. Evidence has suggested that prophylactic use of medicine like acyclovir prior to filler injections is advisable.1
Dr. Kolenda advises that injectors
have emergency kits on hand and have
ready access to hyaluronidase to correct any errors with hyaluronic acid. DT
Dr. Kolenda reports no relevant disclosures.
REFERENCE:
Duffy DM. Complications of fillers: overview. Dermatol
Surg. 2005;31(11 Pt 2):1626-33.
1
CUTANEOUS ONCOLOGY
Scientists gain new insight
into UV-exposure genetics
Melanoma patients live longer when a gene is normal
The UV Radiation Resistance-Associated Gene has earned its clunky name:
It’s been linked to a rare genetic disease called xeroderma pigmentosum
that makes sufferers extremely vulnerable to sun exposure. So much, in fact,
that their risk of skin cancer is thought
to skyrocket by 1,000 times.
But it’s not been clear how the gene
actually works or what happens when it
goes haywire. Now, we’re getting closer
to an answer. New research finds that
the gene plays a big role in the skin’s response to UV rays, raising the prospect
that it could be a biomarker identifying
those at special risk for melanoma from
sun exposure.
“We established for the first time that
the gene is a key player in UV-induced
DNA damage repair,” says Chengyu
Liang, M.D., Ph.D., lead author of the
recent study about this gene.1 “We’ve deciphered how it works and why it is important for UV protection,” Dr. Liang says.
In the big picture, scientists still have
much to learn about links between genetics and skin cancer, says Dr. Liang who is
QUICK READ
Xeroderma pigmentosum is a rare disease that leads to early skin cancer.
New insights may lead to better prevention and survival for patients, as
well as point to ways that UV-resistant
gene functions could be used for skin
cancer prevention and treatment.
an associate professor with the Department of Molecular Microbiology & Immunology at the University of Southern California’s Keck School of Medicine. “Different kinds of skin cancer differ in their
genetics,” she says. “The exact genetic
factors for skin cancer remain a mystery.”
In terms of melanoma specifically, she
says, several gene mutations appear to be
connected to the disease, but there’s no
single one that directly causes it. “In addition, mutations or deficiency of genes
involved in repair of UV-induced DNA
damage are directly linked to dramatically increased melanoma risk,” she says.
The American Cancer Society estimates that 10,130 people will die of melanoma in the United States in 2016, accounting for a huge majority of skin cancer deaths. Sun exposure is thought to
DTExtra
A new photonics device is being developed that
listens to light and could be capable of
detecting skin cancer and other diseases. The
method uses opto-acoustics, sending light waves of different wavelengths into the skin and detecting ultrasound waves generated within tissue in response
to light absorption to build up an image of the skin
tissue and specific molecules therein. The prototype
can visualize at depths up to 5mm, measures 4cm x
4cm x 7cm, and can be placed on the skin to generate a high-resolution image in less than a minute.
SOURCE: BIT.LY/PHOTONICSDX
be responsible for a large percentage of
melanoma cases; research suggests that
regular sunscreen use can dramatically
reduce the number of cases.
RARE DISEASE LEADS TO EARLY CANCER
The UV Radiation Resistance Associated
Gene, a protein coding gene, has been
connected to the xeroderma pigmentosum disease, which affects an estimated
one in 1 million people in the United States
and Europe. It causes extreme sensitivity
to UV rays that results in severe sunburns
and freckling, even in kids under age two
years. Most patients develop multiple skin
cancer lesions, sometimes before age 10.
Researchers have linked the gene to autophagy, membrane trafficking, chromosome stability, and other roles, Dr. Liang
says. But none of these functions explain
its role in UV protection.
Enter the new study. Dr. Liang and colleagues tinkered with the gene in melanoma cells and fly eyes. The researchers
linked the alternate copies of the gene to
more damage from UV exposure due to
an impaired repair process within cells.
In addition, Dr. Liang says, “we comUV GENETICS see page 54
Quotable
It’s usually just the
tip of the iceberg.”
George Martin, M.D.
Maui, Hawaii
Discussing the
importance of treating
field cancerization in
actinic keratosis patients.
See story page 1
53
54
CUTANEOUS
®
ONCOLOGY
AK:
Single lesions can be deceiving from page 1
disease, because we dermatologists feel
that one AK is usually just the tip of the
iceberg. There are likely many subclinical AKs [i.e., field cancerization] present
in normal appearing skin.”
Field cancerization requires field therapy. Although there are many different
modalities available for the treatment of
AKs, Dr. Martin says that less than 10%
of dermatologists use field therapy on
their patients. Some of the reasons include the tremendous downtime associated with therapy (weeks to months)
and pushback from patients because of
the cosmetic side effects. The pain associated with treatment often directly
impacts patient compliance.
“Unfortunately, conventional PDT can
be very painful. While off-label daylightmediated PDT can achieve upwards of 75%
clearance rates and can shift the pain paradigm significantly, this approach is not
feasible in the United States for many reasons, including weather issues and legal
issues, as well as insurance reimbursement,” Dr. Martin says. The off-label, daylight-mediated approach is 30 minutes of
MAL PDT followed by 1½-2½ hours of natural sunlight exposure with sunscreen.
QUICK READ
Innovative modifications of conventional
treatments for actinic keratosis can help
patients live with this chronic disease in
more comfort and greater safety, and
with potentially improved outcomes.
Any one of the field therapies will result in varying degrees of oozing, crusting,
and pain, which at times can be significant for some patients. Recognizing the
therapeutic power, and the drawbacks,
of standing agents and modalities such
as PDT, Dr. Martin set out to optimize
the treatment regimen by adjusting the
parameters of in-office PDT therapy. Dr.
Martin recently conducted a prospective
split-face study1 in three patients, including treatment-associated pain measurements in over 100 patients with AKs, comparing short ALA incubation times of 15
minutes followed by 60 minutes of continuous blue light exposure versus short
contact (one hour incubation) ALA PDT.
Data showed that after one treatment,
the shorter exposure time PDT resulted
in a 52% reduction of AK lesions compared to only 44% with conventional PDT.
None of the shorter incubation time pa-
tients experienced significant pain (>7/10
pain scale) throughout the study, while
traditional PDT patients recorded significant pain.
Pain with PDT has been related to cellular destruction and inflammation, and possibly a direct effect of PDT on nerve fibers.
During treatment, PDT produces reactive
oxygen species that result in tissue destruction, and it destroys AKs because of the preferential accumulation of the photosensitizing molecule protoporphyrin IX (PpIX).
Shortening the incubation time and allowing PpIX to accumulate within the targeted
cells (AKs) without diffusing into the surrounding tissues where the nerve endings
appear to be instrumental in mitigating
the pain associated with in-office PDT
treatments.
“Although the parameters can still be
fine-tuned, this is a major advance for
in-office painless PDT, allowing us to
perform the procedure in a controlled
environment, the same way you do traditional PDT on a regular basis, just without
the procedural pain and logistical nightmare associated with other field therapies,”
Dr. Martin says.
AK see page 55
UV GENETICS:
The role of genetics in melanoma from page 53
paredmelanomapatientswithandwithout
these variations, and those with the normal
form have a better survival rate.”
What does all this mean? “Genetic deficiency of some factors involved in UV damage repair will significantly enhance the
risk of skin cancer patients to UV radiation,
leading to increased disease progression,”
Dr.Liangsays.“Appropriateprotectionfrom
excessive UV for these genetically weak patients such as covering up more and lathering on more sunscreen will help prevent
against UV induced damage and reduce
skin cancer risk.”
Jeffrey Salomon, M.D., FACS, assistant
clinical professor of surgery (plastic) at Yale
University School of Medicine, tells Dermatology Times that the research “helps
pull back the curtain a little” on the role
of genetics in melanoma.
According to Dr. Salomon, the study
shows that the UV Radiation Resistance
Associated Gene is an “important factor”
Researchers linked the alternate copies
of the gene to more damage from UV
exposure due to an impaired repair
process within cells.
in the nucleotide excision repair pathway,
which consists of at least five steps that repair damaged cells. “It is this pathway that
protects the skin from UV-induced mutations.”
WHAT NOW?
It’s not clear whether the dangerous variations in the gene are common, Dr. Liang
says. But eventually, the gene could become a biomarker and be used to identify
patientswhoaremoresensitivetoUVexposure and will need early protection. “Fur-
ther work in preclinical models and some
human genetic studies will be necessary
to confirm this,” Dr. Liang says.
Moving forward, she says, “We will further investigate the mechanism by which
theUV-resistantgenefunctionsinskincancer prevention and treatment.” DT
References:
1. Yang Y, He S, Wang Q, et al. Autophagic
UVRAG Promotes UV-Induced Photolesion Repair by Activation of the CRL4(DDB2) E3 Ligase.
Mol Cell. 2016;62(4):507-19.
CUTANEOUS ONCOLOGY
AK:
Fundamental shift in approach from page 54
Aside from the pain, another critical
limitation of field therapy is the extended
downtime associated with treatment,
which can range from weeks to months
and which can significantly impact patient compliance. Although PDT offers a
selective advantage over the other field
therapies because it has the shortest
downtime, imiquimod remains one of
the most used therapeutic agents for AKs
primarily due to its proven immunomodulatory effect. Over the last quarter century, imiquimod has undergone changes
in its concentration from the original 5%
cream concentration (Aldara, Valeant)
to 2.5% and 3.75% cream concentration
(Zyclara, Valeant) to be used daily for two
weeks, then two weeks off, and then reapply for two weeks.
KEEPING AK AT BAY
Actinic keratosis — like hypertension,
diabetes, and rheumatoid arthritis —
is a disease that has an ongoing presence in the lives of patients. As such,
Dr. Martin says that there needs to be
a fundamental shift in the way clinicians approach AK. Instead of treating
episodically every few months whenever AKs accumulate and become visible to the naked eye in terms of field
cancerization, Dr. Martin suggests that
AK should be treated continually, ad
infinitum.
In many of his patients with field cancerization, Dr. Martin is following a new
A
“The presence of a single AK can be
deceiving in terms of the true scope of
disease...one AK is usually just the
tip of the iceberg, as there are likely
many subclinical AKs present in
normal appearing skin.”
George Martin, M.D.
Kihei, Hawaii
off-label treatment regimen using 3.75%
imiquimod with the goal of treating and
keeping AKs at bay through continuous
immunomodulatory stimulation. Here,
AK patients apply imiquimod every day
for one week, have two weeks off — allowing the crusts and peeling to subside
— then follow-up with once-a-week imiquimod application, indefinitely.
“In addition to the great clearance
achieved with this approach, we’ve also
witnessed very long-remissions. Most of
my patients on this regimen have stayed
clear for over two years and counting,
which is very rarely seen with traditional
prescribed treatment regimens,” Dr. Martin says.
Ideally, the patients who would benefit most from this continuous AK therapy would be those with moderate-tosevere disease. Here, Dr. Martin says
that those patients with field cancerization could receive a combined therapy
B
consisting of in-office painless ALA PDT
to clear the bulk of the lesions, followed
with long-term application of 3.75% imiquimod cream for longer remission.
“We need to optimize our current therapies and in select patients, I believe that
by stimulating the immune system on a
weekly basis with continuous imiquimod therapy, we can suppress the development of precancerous lesions and
skin cancer,” Dr. Martin says. DT
Disclosures: Dr. Martin is a consultant, speaker, and advisory board member at Valeant, DUSA; he is also on the
advisory board at LEO and is a consultant for Aqua.
Reference:
1. Martin G. In-office painless aminolevulinic acid photodynamic therapy: a proof of concept study and clinical experience in more than 100 patients. J Clin Aesthet Dermatol. 2016;9(2):19–26.
C
Patient shown at baseline (A); at the end of a one-week treatment regimen in which the patient applied 3.75% imiquimod daily for one week (B);
and finally at two years of once weekly 3.75% imiquimod treatments (C).
Photo: George Martin, M.D.
55
56
BUSINESS
®
OF DERMATOLOGY
DIGITAL TRANSFORMATION
58 THE
Silicon Valley has set its sights on
healthcare, with wide-reaching implications
SELF DEFENSE
62 AnFINANCIAL
expert shares tips on how to protect
yourself and your business interests
Meaningful use losing meaning?
Experts hope upcoming regulations take derms’ uniqueness into account
Meaningful use has turned out to be a
major nuisance. Now, the federal government is finally promising to put its onerous electronic health records requirements out of their — and your — misery.
So is it a time for rejoicing by every
dermatologist who treats Medicare and
Medicaid patients? Not necessarily. The
hassles spawned by meaningful use
rules have stung dermatologists, and
some aren’t ready to rhapsodize about
better days ahead.
“The government
wants to pretend meaningful use is over, so
they don’t have to reveal how much of a failure it has been,” says
Mark D. Kaufmann,
Dr. Kaufmann
M.D., associate clinical professor with the department of dermatology at Icahn School of Medicine at
Mount Sinai. “I actually am hopeful, but
only for 10-15 years from now, when electronic health records will be interoperable and more intuitive. Until then, we
will have to live with the pain that often
QUICK READ
Regulations surrounding electronic
health records are evolving.
The medical community waits
hopefully for a system that focuses
more on outcomes and less on
the use of technology itself.
accompanies a transition period.”
While dermatologists are unique, the
system hasn’t always treated them that
way, says George J. Hruza, M.D., M.B.A.,
a dermatologist in private practice and
adjunct professor of dermatology at St.
Louis University. “The meaningful use
requirements were set up
primarily with primary
care physicians in mind,
making them extra difficult for specialists like
dermatologists to meet,”
he says.
Dr. Hruza
After hearing complaints, CMS made improvements for
2016. Dermatologists no longer need to
report blood pressure or smoking cessation education, Dr. Hruza says. “The
reporting is more based on demonstrating some of the capability of the EHR
Quotable
software such as secure electronic messaging with patients, protection of personal health information, patient specific
education resources, and electronic
e-prescribing.”
NOW WHAT?
Under the initial plan, meaningful use was
supposed to evolve from Stage 1 (focus
on data capturing and sharing) in 20112012 to Stage 2 (change clinical procedures) in 2014 and Stage 3 (improve outcomes) in 2016.
But then along came the Medicare
Access and CHIP Reauthorization Act
of 2015, also known as MACRA, which
sets new payment models to go into effect in 2019 and threw a wrench into the
workings of meaningful use. Meanwhile,
physicians rebelled.
The Centers for Medicare and Medicaid Services has responded. Acting administrator Andy Slavitt set
the stage for change in a speech at a
conference in January, saying, “The
Meaningful Use program as it has existed, will now be effectively over
and replaced with something better.”
MEANINGFUL USE see page 57
DTExtra
Quality data is oxygen to
companies that want to
build healthcare
products.”
Bob Kocher, M.D.
Palo Alto, Calif.
On healthcare’s transition
into an information business
See story page 58
Experts’ opinions on how to improve the ACA:
“Leverage CMS to combat high drug costs.”
Don Hall, principal of DeltaSigma LLC
“Shift financial incentives to better align with desired patient outcomes at each stage of life.”
Ross Armstrong, healthcare expert at Kurt Salmon consulting
“Repeal the excise tax.”
Tracy Watts, U.S. healthcare reform leader at Mercer
“Address and provide coverage for new technology,
devices, diagnostics, therapeutics.”
Joel Brill, M.D., chief medical officer, Predictive Health LLC
“Ensure equitable access to healthcare.”
Georganne Chapin, former head of Hudson Health Plan
SOURCE: MANAGED HEALTHCARE EXECUTIVE. READ THE FULL ARTILE: BIT.LY/8CHANGESFORACA
58
BUSINESS
®
OF DERMATOLOGY
From the pages of
Silicon Valley’s vision to transform healthcare
Demand for clinical data drives transition of healthcare into information business
SHELLY K. SCHWARTZ | STAFF CORRESPONDENT
WITH REPORTING BY RANDY DOTINGA
It wasn’t only the aging demographic
that prompted high-tech firms to throw
their hats in the healthcare ring. Nor was
it the market opportunities created by the
Affordable Care Act (ACA), nor investor
enthusiasm for software solutions that may
solve some of the healthcare industry’s
most pressing problems. It was all three.
Over the last five years, tech titans
including Google, Intel, IBM, and Apple
have set their sights on the roughly $40
billion healthcare IT market, joining a
proliferation of Silicon Valley startups
that are developing new products to help
achieve the “Triple Aim” of better care,
improved outcomes, and lower costs.
“Since passage of the Affordable
Care Act [in 2010], these trends have
combined and we’ve now got more
than $10 billion of new venture capital
dollars flowing into the healthcare IT
industry, and more than 500 new companies created,” says Bob Kocher, M.D.,
an internist and partner with venture
capital firm Venrock in Palo Alto, Calif.,
which invests primarily in healthcare
and technology.
An additional 17 million
“Qualit y data is ox ygen
Americans, he notes, have
to companies that want to
g a i ne d he a lt h i n s u r a nc e
build healthcare products,”
coverage under the ACA at
Dr. Kocher says, adding new
a time when retiring Baby
payment models that reward
Boomers are already fueling a
for value also are boosting
spike in demand for healthcare
demand for clinical informaservices. “We’re adding 10,000
tion technology and adminisPERCENT
Medicare beneficiaries every
trative solutions.
Chronic illnesses
day, and older people spend
Globally, the healthcare IT
consume 86%
more on healthcare, so from a
market,
which includes EHRs,
of the nation’s
purely economic standpoint, healthcare costs telemedicine, and computthe opportunity in the healtherized provider order entry
care market is enormous, intersystems, is expected to top $105
esting, and growing,” Dr. Kocher says.
billion by 2020, up from $41 billion in
Spending on medica l ser v ices,
2013, according to market research firm
including hospital visits, medications,
Grand View Research in San Francisco.
and other healthcare services, will
To a large degree, that growth is being
account for nearly 20% of U.S. gross
powered by the cloud, clinical- and
domestic product by 2021, according to
claims-based analytics, and mobile
government projections.
technologies.
Other catalysts for IT innovation:
the Health Information Technology
HEALTHCARE AS AN INFORMATION BUSINESS
for Economic and Clinical Health Act
Sam Glick, a partner with New York-based
of 2009, which incentivized doctors to
management consulting firm Oliver
purchase electronic health record (EHR)
Wyman, says IT innovators are uniquely
systems, and the federal Health Data
positioned to uncover new sources of
Initiative, which requires providers to
value as payers and providers digitize
report on cost and quality data.
patient records and researchers aggregate
mountains of medical data.
“Over the past decade, healthcare
has evolved to become an information
business,” he says. “It’s not just about
scientific innovation, not just about
finding new ways to engage people, but
increasingly it’s about how do we know
which patients are going to be the sickest
sooner, what costs are going to be the
most significant, and how can we predict
which patients we should reach out to
today? These are information questions
that the Googles and Apples of the world
are very well equipped to answer.”
Their foray into healthcare, he notes,
follows a more pervasive corporate trend.
“There is a move across all industries —
from hospitality to financial services
to retail — to empower consumers and
find new ways to engage them,” Mr. Glick
says. “Companies are using big data to
86
“One of the challenges for dermatologists,
as well as other specialties, is the sharing
of electronic medical records…As of now,
with the various competing electronic
medical record formats, which do not
talk to one another, there is often a gap
in communicating with other
dermatologists about laboratory
results, past medication use,
etc., which slows down the
process of medical care.”
Norman Levine, M.D.
Tucson, Ariz.
SILICON VALLEY see page 59
BUSINESS OF DERMATOLOGY
SILICON VALLEY:
Waiting for improvements in EHRs from page 58
make for a better, more convenient, more
targeted consumer experience.” It’s a
move toward mass personalization, he
says, in which service providers have the
power to customize for the individual —
and healthcare is no exception.
Analytics, simulation models, and
optimization programs are already
giving early adopters the insight to
deliver more personalized, proactive
care. A 2014 Price Waterhouse Coopers
survey found that 63% of healthcare
executives say they’ve changed the
way they make important decisions as
a result of “big data,” such as whether
they should change their deliver y
model, collaborate with competitors,
commit to a major business investment,
or encourage the use of mobile health
technologies.
“There’s no
question that the
interest of these
tech companies
is a good thing
because it draws
more attention,
creativity, and
resources to
healthcare.”
Bob Kocher, M.D.
internist and partner, Venrock, Palo Alto, Calif.
The survey found that some 40%
rely primarily on data and analytic
inputs, 29% draw on their own experience and intuition, and 31% look first
to the relevant experience of others.
Many of the larger medical groups who
responded also said they had recently
created a dedicated data insights team to
inform strategic decisions. Healthcare IT
includes an array of technologies to store,
share, and analyze health information.
For patients, it enables better access
to care via telemedicine and patient
portals. Telemedicine, which allows
medical professionals to examine and
treat patients remotely, is especially well
adoption. “So, from the EHR space, the
suited for use by dermatologists, says
model is trying to develop new applicaNorman Levine, M.D., a dermatologist
tions that could interface with existing
based in Tucson, Ariz.
EHR solutions to deliver greater effi“In most cases, a photo is sufficient
ciency,” Mr. Nam says. “While there are
to make a diagnosis,” he says. “This
a ton of companies working on these
saves the patient time and money. It also
solutions, they have to deal with the
could work well for the dermatologist
restrictions imposed by the EHR players,
committed to this technology, which
so it is a bit more difficult to make a busihas matured to the point where it can be
ness case.”
effectively used today if there is a will on
It ’s fa r easier to develop more
the part of the physician, the insurance
universal solutions that improve patient
carrier and the patient.”
care and outcomes, including physiFor researchers, healthcare
cian concierge services, data
63% of
IT allows for more granular
mining services, and schedhealthcare
analysis of health data for
uling apps that attract more
the development of new executives say they’ve investors and public attenchanged the way
therapies, and for providers
tion, he says.
they make important
it helps identify opportuniIBM’s Wat son Hea lt h
ties to improve efficiency and decisions as a result C l o u d i s a n e x a m p l e .
of big data.
outcomes.
Launched in 2015, the open
Medical professionals are
technology platform is designed
especially hoping for improvements
specifically to enhance the quality
in EHRs. “One of the challenges for
and effectiveness of personal healthcare
dermatologists, as well as other specialusing language processing and machine
ties, is the sharing of electronic medical
learning. It is intended to help doctors,
records,” Dr. Levine says. “As of now,
researchers, and others in the healthcare
with the various competing electronic
field to automate and improve patient
medical record formats which do not
outreach, boost patient engagement,
talk to one another, there is often a gap
and reduce costly hospital readmissions.
in communicating with other dermaGoogle Genomics and Amazon Web
tologists about laboratory results, past
Services also are jockeying for position in
medication use, etc., which slows down
the high-stakes race to store DNA data.
the process of medical care.”
Both companies are marketing their
Many of the latest innovations are
cloud databases to drug makers and
aimed at personal health treatment for
research institutions, which are thempatients — particularly those suffering
selves rushing to sequence hundreds
from chronic illness, which consumes
of thousands of human genomes for
86% of the nation’s healthcare costs, the
medical research and development.
Centers for Disease Control and PrevenTech firms bring a unique skill set to
tion reports.
the market, Mr. Glick says. “They bring
expertise in technology, but also in
PRODUCTIVE PARTNERSHIPS
consumer engagement,” he says. “People
“Most of the ‘hot’ stories in healthcare IT
love Google and Apple and Amazon for
today are related to patient care/outcomes,”
the user experience they provide. They
says Spencer Nam, a senior research
are much more beloved by the average
fellow for healthcare at the San Mateo,
consumer than most hospitals or health
California-based Clayton Christensen
plans.”
Institute for Disruptive Innovation.
Recent ly, t he most substa nt ia l
“Even if the solution itself is more
commitments to healthcare IT have
related to operational improvements,
been partnerships between tech firms
they are still being positioned and
and medical researchers, which lend not
marketed as ‘patient outcome’-related
only scientific credibility to their discovsolutions,” says Nam.
eries, but multidisciplinary expertise.
In part, that’s because administra“Pharmacists, nurses, and doctors are
tive functions are largely tied to — and
among the most trusted professionals
limited by — EHRs, for which the Affordin the United States so these partnerable Care Act mandated systematic
SILICON VALLEY see page 65
59
60
BUSINESS
®
OF DERMATOLOGY
Professionalism in social
media is a balancing act
Protect your image by being deliberate with your posts
Social media is serious business,
and keeping one’s professionalism is
paramount. Dermatologists’ activities
on Facebook, YouTube, Twitter and other
social networking sites can and will be
used for and against them, according
to David J. Goldberg,
M.D., J.D.
“A l l mater ia ls on
these sites can be used
as evidence (both positive and negative) in a
court of law and by state
Dr. Goldberg
board of medical examiners. Most common suits are for either
medical malpractice or fraud,” says Dr.
Goldberg, clinical professor of dermatology and director of laser research at
Mount Sinai School of Medicine. Dr.
Goldberg is also an adjunct law professor
at Fordham Law School.
SEPARATE PERSONAL FROM PROFESSIONAL
Dermatologists, like all physicians, should
separate their personal and professional
lives on social media platforms and adhere
to professional standards of practice,
according to experts. On Facebook, for
example, that means having a practice
page and a very separate personal page,
blocked from general view with privacy
settings.
Dr. Goldberg says it’s best to keep
friendly activities on personal — not
QUICK READ
To establish and maintain a
professional medical image in social
media, pay careful attention to the
content of posts. Be aware that
social media content is admissible as
evidence in courts of law.
practice or professional — pages.
WHAT’S OFF LIMITS?
If your goal is to gain followers and improve
your professional presence, you’ll want to
avoid topics that might alienate the very
people you’re trying to reach.
“It really depends on how you view
your feed and how you view your public
presence. For most physicians, they want
to maintain a professional presence
in public. Similarly, when you are on
a couple of platforms, where there are
patients and hospital administrators,
and your colleagues are there, you’re
going to conduct yourself like you would
if you were in a restaurant in public or
a meeting,” says Bryan Vartabedian,
M.D., pediatrician, assistant professor of
pediatrics at Baylor College of Medicine,
Houston, and founder of 33Charts.com,
a blog he started in 2009, which explores
the intersection of medicine, social
media and technology.
Highly-charged personal opinions
about controversial topics are, in most
cases, better left to your personal conversations and platforms.
“When you are on a couple of platforms,
where there are patients and hospital
administrators, and your colleagues are
there, you’re going to conduct
yourself like you would if you
were in a restaurant in public
or a meeting.”
Bryan Vartabedian, M.D.
Houston, Texas
Dr. Vartabedian says that he avoids
religion and politics, tends not to talk
about alcohol, and doesn’t badmouth his
employer and hospital.
“There are some physicians who are
really passionate about the fact that we, as
physicians, should be talking about politics, and we should be politically active. I
get that,” Dr. Vartabedian says. “But if you
take [any] Presidential campaign…let’s
say you’re a dermatologist and you had
a very busy and active Twitter following.
If you started talking about which candidate you were endorsing or behind, you
would very likely have alienated half the
people you were following.”
“All materials on
these sites can be
used as evidence
(both positive and
negative) in a court
of law and by state
board of medical
examiners.”
PROFESSIONAL, BUT HUMAN
Social media engagement means revealing
your character and parts of your personality. So, while doctors need to keep things
professional,they shouldtryto avoidcoming
across mechanically or robotically.
Patricia Redsicker,
social media manager for
the U.S. Pharmacopeial
Convention (USP) and
a former social media
consultant for dermatologists and others, says
Ms. Redsicker
it helps to build relationships when doctors show personality.
Some might sign off on blogs and some
posts with their first name, like Dr. Joe.
“I’ve been talk ing to this family
doctor in New Jersey, and he always
signs off ‘Greg’ on Google +. I feel like I
know him. Makes him more approachable and likeable,” Ms. Redsicker says.
“Definitely show your personality, but
be careful with the actual content of the
conversation.” DT
62
BUSINESS
®
OF DERMATOLOGY
David B. Mandell, J.D., M.B.A.
is an attorney and author,
as well as a principal of the
financial consulting firm
OJM Group.
Financial self-defense for dermatologists
s a dermatologist, you are
accustomed to patients understanding the value of a specialist. They are coming to you for help with
skin-related medical issues because
you have specialized in helping patients
take the best possible care of their skin.
This seems so obvious it is hardly worth
mentioning.
However, the way things work in the
financial world can be anything but obvious. At one time or another many
dermatologists have gone to a financial advisor. Using the analogy above,
you would expect your financial advisor to take the best possible care of
A
QUICK READ
Education is crucial for protecting
yourself from possible misconduct
from financial advisors. Recognizing
these red flags can help you choose
wisely and avoid mistakes.
Not necessarily. You have no way of
knowing what kind of relationship this
person has with the financial advisor or
even what they value in an advisor. And
since each financial plan, planning process and investment portfolio is different, an advisor that meets your friend’s
or family member’s needs may not be
able to meet yours.
An advisor that meets your friend’s or
family member’s needs may not be able to
meet yours.
your money. Unfortunately stories about
financial fraud and mismanagement
make many investors wary of financial
advisors — with good reason. However,
it’s important to remember that just as
there are financial advisors with dishonest practices, the vast majority truly
want to give you the best level of financial care possible.
How can you distinguish the good
advisors from the bad and protect yourself from financial misconduct?
These red flags will help you learn
how to choose wisely by spotting common unethical practices and mistakes
people make — and avoid them.
DUE DILIGENCE
It can be overwhelming to research and
meet with different advisors, so it may
be tempting to take the first recommendation you get from a friend or family
member. After all, if it worked for them,
it will work for you, right?
You should still do your own background check on your financial advisor.
If they are accredited, verify their accreditation. Also ask the advisor about
fees and to identify his or her licensing
or supervising organizations — depending on the type of financial professional,
this may be the CFP board, FINRA, the
SEC or a different organization. Using
the organization’s website will allow
you to do a more thorough background
check to see if the advisor has a history
of disciplinary action.
➊
Making investment checks
out to the advisor
Your financial advisor should never ask
you to write a check out to him or her
personally for an investment. Instead,
the check should be made directly to
the product sponsor, such as the mutual fund company in which you are investing.
If an advisor tells you that he or she
will deposit the check and make sure
the funds go to the investment, he or
she could simply keep the money and
then falsify investment statements. If an
advisor suggests this, it is a cause for
concern. You should question any situation that involves giving a financial professional unlimited access to money intended for investment — if you’ve found
a financial advisor that puts your needs
ahead of theirs, this shouldn’t happen.
➋
Leaving important forms blank
or incomplete
If a financial advisor offers to complete any type of financial form “to make
things easier for you,” insist on doing it
yourself. At worst, a dishonest advisor
could falsify your information. At best,
a careless advisor with good intentions
could make an error on the form.
This can be dangerous if your income
or net worth is misrepresented, as it could
make you eligible for investments that
aren’t suited to you, leaving you open to financial loss. Avoid leaving blanks on any
financial document you’ve signed, and ask
your advisor to send you copies of final
documents so that you have evidence of
their accuracy should anything occur.
➌
Investing in a “private”
or “exclusive” opportunity
Take pause if your advisor offers you some
sort of “special” investment and you notice that he or she is handling the details of
this investment differently than in the past.
For example, if the advisor wants to meet
outside of his or her office to discuss it, or
if the investment letter appears on different
stationery or with a different logo; these
may be signs that your advisor is selling
an investment the employer doesn’t know
about and/or supervise.
If so, ask the employer/company directly whether it approves of the investment. If your advisor is a sole practitioner,
verify that he or she carries professional
SELF-DEFENSE see page 64
64
BUSINESS
®
OF DERMATOLOGY
SELF-DEFENSE:
Know the details so you can protect yourself from page 62
liability insurance. Without verification that
the investment is legitimate and supervised by the company, you may be unable
to make a legal claim should the investment go bad.
If your advisor pitches investments to
you that have high returns with no risk,
they may be hiding other costs. Make
sure you are getting a fair and comprehensive description of an investment’s
If your advisor pitches investments to
you that have high returns with no risk,
they may be hiding other costs.
Remember that investments should
always be regulated/supervised by an
independent third party and the risks and
possible conflicts of interest fully disclosed to the investor.
➍
Receiving investment reports
only from your financial advisor
or not at all
You should receive regular investment
statements from someone other than
your financial advisor, such as the custodian of your assets or the brokerage
firm that handles your investment. As
an example, the custodians that my firm
uses to provide independent reports include Charles Schwab & Co. and TD
Ameritrade, among others.
If you receive reports from your advisor, make sure they match with these
third-party reports and bring up any discrepancies immediately. If you have any
investments that aren’t evaluated frequently or held by a third-party custodian, verify that the investment manager
is audited frequently by an independent
accounting firm.
➎
Staying with advisors who claim
they can “beat the market”
As a financial professional, beating the
market is an admirable accomplishment
— but no one can promise you that they’ll
be able to achieve it. It’s rare to actually
outperform the market, and chances are
that an obsession with doing so will cause
an advisor to seek out higher-risk investments to make it happen.
pros and cons, and if you find that
you’re only hearing the pros, you may
want to reconsider. Ask what circumstances would cause the investment to
perform worse than projected, and consider changes in both the economy and
your own personal circumstances.
Overall, you should make sure that investment discussions are focused on
your specific needs and how a certain
investment can meet those needs, not
simply on why this one investment is the
greatest of them all.
➏
Giving in to unnecessary financial pressure
Whether your advisor is asking you to
make a decision about an investment
or policy in a very short time frame or
approaching you with a major financial decision just after a devastating
life event, such as death or divorce, remember that you are still in control.
You should be cautious of any pressure tactics during a major life change,
when your decision-making ability may
be compromised.
If this is the case, you may want to
find an advocate, such as a close family member, to help you with any urgent
financial decisions, such as tax deadlines. On less urgent decisions, it may
be best to wait for a while until you’ve
had some time to heal mentally. If you
feel your advisor is trying to rush you
into any kind of decision, speak up.
Make sure you know your advisor’s fee
structure and look into if your purchase
of a policy or investment in a certain
time frame will give a generous kickback.
You should also remember that many
insurance policies or annuities offer a
“free look” period, which gives you a
window to back out without incurring
penalties.
Your advisor should recognize that financial decisions are important and give
you the time and space necessary to
make them; if not, ask yourself whether
he or she truly has your best interests
in mind.
➐
Making financial decisions without knowing all the details
Many people think if they have a financial advisor, they don’t need to be educated about finance. However, you need
to at least know enough to be able to
assess if your advisor is helping you.
If you don’t understand something,
ask. Your advisor may have completely
ethical intentions but simply not know
that you don’t understand him or her. It’s
the advisor’s job to make sure you understand any advice given to you, but an
advisor can’t do that if you claim to understand something when you don’t. DT
Disclosures:
OJM Group, LLC. (“OJM”) is an SEC registered investment adviser with its principal place of business in the
State of Ohio. OJM and its representatives are in compliance with the current notice filing and registration
requirements imposed upon registered investment advisers by those states in which OJM maintains clients.
OJM may only transact business in those states in
which it is registered, or qualifies for an exemption or
exclusion from registration requirements. For information pertaining to the registration status of OJM, please
contact OJM or refer to the Investment Adviser Public
Disclosure web site (www.adviserinfo.sec.gov).
This article contains general information that is not
suitable for everyone. The information contained
herein should not be construed as personalized
legal or tax advice. There is no guarantee that the
views and opinions expressed in this article will be
appropriate for your particular circumstances.
SPECIAL OFFER
Get a free copy of OJM’s new book, Wealth Protection Planning for Dermatologists, co-authored by Dr. David Goldberg,
practicing dermatologist, clinical professor and attorney. For a free hardcopy or ebook download for your Kindle or iPad,
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BUSINESS OF DERMATOLOGY
SILICON VALLEY:
Collaborations enable access to health data from page 59
ships are really important right now,”
Mr. Glick says, adding that may change
as delivery channels evolve.
“Today, most patients go into their
doctor’s office to receive care, but I
could envision a world 10 years from
now where instead of going to a clinic or
urgent care center, they might click on
Google and find a link across the top of
the page next to ‘news’ that says ‘medical
visit’ where they could be seen using
telehealth technology.”
Collaborations between IT firms
and medical organizations also enable
access to health data, which tech firms
need to develop new products and
service platforms. Due to regulatory and
legal constraints, they would otherwise
be forced to gather such data on their
own, which would be time consuming
and costly, but potentially better for the
industry, Mr. Nam says.
“Partnering with healthcare enterprises expedites time to access and obviates the need for ‘reinventing the wheels’
of gathering data,” he says.
But there’s always a risk of tech
companies being exposed to the existing
bias of their partners. “To some extent, I
wish tech companies were bolder and
more innovative by running their own
trials, gathering data themselves (with
help of in-house experts, of course), and
presenting them to the medical community,” Mr. Nam says, noting that’s the
likely next step in their evolution. “But,
for now, these newly built relationships
allow the tech companies to speed up on
their healthcare domain knowledge as
well as gain hard-to-access patient data.”
Wearable tech and cognitive computing
may sound futuristic, but they’re also
good examples of disruptive innovation.
The Carnegie Mellon University Disruptive Health Technology Institute defines
disruptive technology as the process by
which a product or service takes root
initially in simple applications at the
bottom of a market and then relentlessly
moves up-market, eventually displacing
established competitors to yield an
unexpected benefit to consumers.
Aided by new diagnostic and therapeutic tools, non-physician providers
(nurse practitioners, for example) now
can treat conditions that once required
the expertise of a physician at clinics in
CVS, Walgreens, and Walmart stores.
That same evolution is enabling physicians to perform tests and procedures in
the exam room that once required a highpriced specialist or hospital admission.
BIG NAMES BRING ATTENTION TO HEALTHCARE
By all accounts, innovation is the cure
to fix the ailing healthcare system. New
gadgets and gizmos, however, are just
the beginning. As big data redefines the
way doctors deliver care, medical schools,
payers and providers will need to keep
pace, Mr. Glick says.
“Right now we have a lot of experiments between Apple and the Mayo
Clinic, for example, but if we get to the
point where big data tells us that we
should be treating patients differently,
that this population of patients needs
more care and these need less, we’re
going to have to adjust our entire healthcare system,” Mr. Glick says.
Doctors may no longer need a stethoscope, but learn instead to wield a smartphone app that defines more precisely
what each patient needs.
“Training may have to focus more
on information skills,” Mr. Glick says.
“We may need a whole new category of
professionals who are able to interpret
genetic test results, or coaches who
help people change behaviors and stay
healthy.”
At the same time, payers will need
to alter their reimbursement structure
so providers at all levels get paid fairly
for the work they do. “It’s an exciting
time and I’m very optimistic, but if we
succeed, and I think we will, we’re going
to have to think about how the rest of the
system needs to evolve,” Mr. Glick says.
Dr. Kocher agrees. By bringing their
resources to bear and soliciting input
from healthcare decision makers, he
says, Silicon Valley can help doctors
deliver more cost-effective, patientcentered care.
Their foray into the field is already
paying dividends. “There’s no question
that the interest of these tech companies
is a good thing because it draws more
attention, creativity and resources to
healthcare,” Dr. Kocher says. DT
IRREGULAR BORDER:
While interest in alternative therapies grows, the evidence is still murky from page 13
to support this approach for
VINEGAR
seborrheic dermatitis (think:
Finally, vinegar has become
Malassezia is an external pathoan interesting panacea in
gen, and Candida elimination
some circles, with some toutdiets target a different organism
ing a daily draught and others
altogether), many patients anecswearing by topical use. When
dotally feel that their condition
the National Eczema Associaworsens with heavy ingestion of
tion conducted a Facebook
PERCENT
refined sugars and simple carbs. improvement in poll on most popular home
The American Academy of
SD symptoms remedies for seborrheic derDermatology’s recent acne conusing tea tree matitis, apple cider vinegar
sensus guidelines include recfigured prominently; so too,
oil shampoo
ommendations for a low dietary
though, did topical baking
glycemic index. The same counsoda. So, are users conducting
sel on complex carbs and whole grains for
their own mini Henderson-Hasselbalch
anti-inflammatory purposes would apply.
titrations?
41
And while seemingly innocuous, topical vinegar is rather caustic, with the
potential for chemical burns,9 so it is
important to counsel patients on dilution techniques.
In conclusion, while conventional
remedies exist, nature’s bounty may
offer some additional options to mitigate this particular “-rrhea.” As always,
patients should be encouraged to
discuss with you all supplements and
topical botanical preparations to avoid
potential adverse effects. DT
References online:
bit.ly/AlternativesForSD
65
68
Marketplace
Dermatology Times |
July 2016
PRODUCTS & SERVICES
BUSINESS OPPORTUNITY
PRODUCTS
L O C AT I O N !
Turn-key cosmetic medical
office in Beverly Hills available sublease/
lease assignment. Ideal for cosmetic /
plastic / derm / physician wanting presence
in BH triangle. 3 exams, Dr. Office,
consulting office, administrative & nurses
station, designer reception, front desk for 2.
Adjacent AAAHC accredited OR. Easy
access, valet, parking lots. Negotiable terms.
Contact : [email protected]
OTC PRODUCTS
PRACTICE FOR SALE
1(:/<'(9(/23(''(50$72/2*<
35$&7,&()256$/(
Beautifully finished dermatology practice that has
been operating 2.5 days weekly for past 4 years in
an upscale Chicago suburb is ready for a full time
dermatologist/Mohs surgeon. Entirely paperless
scheduling and billing systems, full-body narrowband UVB equipment onsite.
The cost of this practice is less than half of typical
dermatology practices of this scale. A must see
opportunity.
SOLO DERM PRACTICE FOR SALE
In high sun damage Colorado in huge
outdoor recreation area with small
town benefits- Call Maida L. Burrow,
MD, in Grand Junction 970-216-9793
to take good care of my patients.
You will love the price and the location.
email inquiries to: [email protected]
NATIONAL
Marketplace
★
Can Work For You!
★
Reach highly-targeted,
market-specific business
professionals, industry
★
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experts and prospects by
placing your ad here!
PRODUCTS & SERVICES
ADVERTISING
Call Tamara Phillips
to place your
Showcase ad at
800.225.4569 ext. 2773
[email protected]
★
PRACTICE SALES
& APPRAISAL
Expert Services for:
Buying or Selling a Practice
Practice Appraisal
Practice Financing
Partner Buy-in or Buy-out
We Buy Practices
t Retiring
t Monetization of your practice
t Locking in your value now
t Succession planning
t Sell all or part of your practice
www.TransitionConsultants.com
Please call Jeff Queen at
(866) 488-4100 or
email [email protected]
www.MyDermGroup.com
RECRUITMENT ADVERTISING
RECRUITMENT
ADVERTISING
Call for a Free Consultation
(800) 416-2055
Call Joanna Shippoli
to place your
Recruitment ad at
800.225.4569 ext. 2615
[email protected]
Can Work For You!
Reach highly-targeted,
market-specific
business professionals,
industry experts and
prospects by placing
your ad here!
July 2016
|
Marketplace
CAREERS
CONNECTICUT
NATIONAL
WATERBURY, CONNECTICUT
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
Advanced Dermatology and Cosmetic Surgery, the largest dermatology
practice in the country with over 150 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 office practice!
t )JHIMZDPNQFUJUJWFTBMBSZ t 'VMMCFOFåUT t .VMUJQMFMPDBUJPOT
BE/BC DERMATOLOGIST
t Unique opportunity to join concierge type
practice in affluent metro New York suburb.
t Candidate’s primary focus would be on nonaesthetic dermatology with opportunity for
growth in aesthetic arena.
t BBL/Laser hair removal with Fraxel, Pico &
Resurfacing and spa on site.
t Part – time possible.
For immediate consideration, send your CV today!
Submit CV to
Christie Knowles at [email protected]
Call 904-354-4488 or 904-509-8537 (cell)
NATIONAL
COLORADO
E-mail resume to [email protected]
DELAWARE
WILMINGTON, DELAWARE
Partnership Opportunity
www.MyDermGroup.com
MOHS SURGEON
MULTIPLE PART TIME OPPORTUNITIES
Bountiful, UT
3-4 days/mo
Calumet City, IL
1-2 days/mo
Enfield, CT
2-3 days/mo
Groton, CT
1-2 days/mo
Hickory, NC
1-2 days/mo
Montrose, CO
1-2 days/mo
Sanford, NC
2-3 days/mo
Tampa, FL
1-2 days/mo
Washington DC
2-3 days/mo
www.MyDermGroup.com
DENVER AREA, COLORADO
General Dermatologist Opportunities
Contact Christie Knowles, (904) 354-4488 or
[email protected]
CONNECTICUT
CLINTON, CONNECTICUT
CALIFORNIA
DISTRICT OF COLUMBIA
WASHINGTON, DC
www.MyDermGroup.com
www.MyDermGroup.com
FLORIDA
PORTERVILLE, CALIFORNIA
www.MyDermGroup.com
MYSTIC/GROTON, CONNECTICUT
MIAMI, FLORIDA
www.MyDermGroup.com
Associate Opportunity
www.MyDermGroup.com
COLORADO
LONE TREE, COLORADO
SOUTHBURY, CONNECTICUT
TAMPA, FLORIDA
www.MyDermGroup.com
www.MyDermGroup.com
www.MyDermGroup.com
69
70
Marketplace
Dermatology Times |
July 2016
CAREERS
FLORIDA
ILLINOIS
Florida Coastal Dermatology is a successful Dermatology
Practice with offices in Naples and Estero, Florida and has
been providing a full spectrum of superior surgical, medical
and cosmetic Dermatology since 1989.
We are currently seeking an outgoing Dermatologist to join our team. In
this role, you will have the opportunity to provide care to a wide variety of
patients in our beautiful new Estero office. Live and work in paradise while
achieving the work/life balance you’ve been looking for.
South West Florida is a growing area
with abundant cultural and recreational
opportunities. Beautiful neighborhoods,
excellent schools and unlimited indoor and
outdoor activities make South west Florida
the place to be.
“Competitive Compensation
and Benefit Package”
CALUMET CITY/DYER, IN
www.MyDermGroup.com
LOUISIANA
PONCHATOULA, LOUISIANA
www.MyDermGroup.com
Barefoot Beach voted one of the top 10
beaches in the US
MARYLAND
ROCKVILLE, MARYLAND
Email: Kimberly.weigert@flcda.com
Phone: 239-263-1717 ext 210
www.floridacoastaldermatology.com
www.MyDermGroup.com
GEORGIA
WHITE PLAINS, MARYLAND
CENTRAL FLORIDA
[email protected]
ATLANTA, GEORGIA
www.MyDermGroup.com
[email protected]
DELAND, FLORIDA
[email protected]
FLORIDA
GENERAL DERMATOLOGIST OPPORTUNITIES
Heathrow
Jacksonville
Lakeland
Winter Park
[email protected]
INDIANA
[email protected]
MEDICAL/COSMETIC
DERMATOLOGIST OPPORTUNITY
MASSACHUSETTS
Employment opportunity within network of over 80
providers (mostly primary care). Join one general
medical dermatologist. Busy practice; ramp up
quickly. Procedures scheduled daily. Competitive
compensation and benefit package. Sister city to
South Bend; home of Notre Dame.
ALBANY, GEORGIA
WORCESTER, MASSACHUSETTS
Partnership Opportunity
www.MyDermGroup.com
Contact: [email protected]
MICHIGAN
GEORGIA
[email protected]
TOWSON, MARYLAND
SAINT JOSEPH HEALTH SYSTEM
SAINT JOSEPH PHYSICIAN NETWORK
MISHAWAKA, INDIANA
Recruitment Advertising
Can Work For You!
PETOSKEY and TRAVERSE CITY, MICHIGAN
[email protected]
July 2016
|
Marketplace
CAREERS
MICHIGAN
NORTH CAROLINA
OHIO
HICKORY, NORTH CAROLINA
LANSING, MICHIGAN
[email protected]
www.MyDermGroup.com
MONTANA
OHIO
GENERAL DERMATOLOGIST OPPORTUNITIES
Beaver Creek
Dayton
Mason
Contact Christie Knowles,
(904) 354-4488 or
[email protected]
OREGON
Montana,
Wide open spaces, fresh mountain air, and forever views that follow you no
matter where you go. Billings, Montana is your trailhead to unspoiled nature and beauty unlike
anywhere else in the country. Known worldwide for its wide variety of terrain and adventures,
Montana is truly an outdoor enthusiast’s paradise. With hiking trails, fishing holes, lakes, and
rivers, Glacier and Yellowstone National Parks, Pompey’s Pillar, the Custer Battlefield, and
twelve different ski hills to choose from all within a day’s drive...
The only thing you’ll worry about is deciding how to spend your days off.
Part Time/Full Time Dermatologist for General/
Cosmetic/Surgical practice in Eugene, Oregon.
Dreyer Dermatology for 30 years has been setting the
standard for excellent patient care. Eugene is rich in both
outdoor sports but cultural offerings as well. Excellent
schools and access to world class healthcare provides
opportunities for great work-life balance.
Work-life benefits include:
r'MFYJCMFXPSLIPVSTr(FOFSPVT.BUFSOJUZMFBWF
r(VBSBOUFFE*ODPNF
Please forward cover letter and Resume to:
[email protected]
PENNSYLVANIA
BC/BE Dermatologist
PENNSYLVANIA
Highly-regarded, thriving practice
St. Vincent Healthcare in Billings, Montana is seeking a U.S. trained BE/BC
certified physician for our Dermatology & Skin Cancer Center.
t
t
t
t
t
t
Full time employed position.
Full complement of medical specialties available.
Thriving medical community in a family-oriented suburban location.
Abundant year round recreation – hiking, skiing, fishing, biking and camping.
Competitive salaries with productivity incentives.
Start Date Bonus, Moving Allowances and CME Reimbursement.
C o n t a c t [email protected] or visit www.svh-mt.org to apply.
NEW YORK
ALBANY, NEW YORK
&632<1%2,%88%22='
www.MyDermGroup.com
7))/-2+()61%8303+=4,=7-'-%2%77-78%287
BUFFALO, NEW YORK
Associate Opportunity
www.MyDermGroup.com
with 7 dermatologists seeks
BC/BE Dermatologist.
State of the art 12,000 sq. ft. facility with
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,
highly picturesque, family-oriented community
within 1 hour of Philadelphia and Baltimore.
Call Bonnie Oberholtzer at
(717) 509-5698
or e-mail to: [email protected]
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0SSOMRKXS[SVO%YXSRSQSYWP]#
;IPPIWXEFPMWLIHXLVMZMRKQYPXMGIRXIV(IVQEXSPSK]
TVEGXMGIWIIOMRK(IVQEXSPSK]4L]WMGMER%WWMWXERXW
)16ERH7TERMWLE4PYW
,MKLP]GSQTIXMXMZIGSQTIRWEXMSR
)1%-0':()612=1$KQEMPGSQ
Repeating an ad ENSURES it will be
seen and remembered!
Well-established private practice based
in West Chester, PA looking for part-time
dermatologist for our Springfield location.
“Compensation Percentage Based”
“Flexible Hours”
Email [email protected]
71
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AQUA PHARMACEUTICALS
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AQUA PHARMACEUTICALS
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GALDERMA LABORATORIES
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LEO PHARMA INC
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SANOFI/REGENERON
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This index is provided as an additional service. The publisher does not assume any liability for errors or omissions.
73
74
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.
A simple complication, a massive lawsuit
D
r. Derm has a very large dermatology practice where he
practices both medical and
cosmetic dermatology. In addition, Dr. Derm is actively involved in many
clinical research studies. His patients love
to become research subjects because:
1) they are treated at no charge; and
2) they receive compensation for their
travel and expenses getting to his office.
Many studies require that blood be
drawn as part of the research protocol. One subject, a 32-year-old investment banker, had her blood drawn at the
end of a particular FDA study visit. After
Dr. Derm’s medical assistant drew her
blood, the assistant told the patient to
get dressed and schedule her next appointment.
Fifteen minutes later, Dr. Derm walked
in to the exam room and found the patient
on the floor. She had experienced a vasovagal reaction. Dr. Derm was able to get
her on the table and she seemed to recover. He sent her home.
SEIZURE LEADS TO DEATH
That night, the patient had a seizure and
was taken to the emergency room. She
was found to have a large subdual hematoma from the fall after the vasovagal
episode. Unfortunately, she died three
days later.
The deceased patient’s family (husband and two children) filed a $20 million
dollar lawsuit against Dr. Derm and his assistant. He is beside himself. How could
this happen from a simple fainting episode? And, he was treating her for free.
Shouldn’t he be protected while undertaking an FDA trial?
We often worry about complications
Dermatology Times (Print: ISSN 0196-6197, Digital ISSN 2150-6523) is
published monthly by UBM Medica 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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55806 and additional mailing offices. POSTMASTER: Please send address
changes to DERMATOLOGY TIMES, c/o PO Box 6013, Duluth, MN 55806-
from our various evaluations and treatments. Did I miss a melanoma on a full
body exam? Will my patient be scarred
from a laser procedure? Will my patient
have an untoward reaction to an oral
medication?
These are all serious complications
and may lead to a lawsuit. However, even
the simplest procedure can be fraught
with hazards that may lead to a lawsuit,
but are easily prevented.
Could a mistake by
his medical assistant
lead Dr. Derm to
lose a large medical
malpractice case?
LEGAL PRECEDENT
Such an issue has precedent. In Nelson v.
Emory Healthcare, 55-year-old Chris Nelson had blood drawn as part of a wellness exam. He was seated upright on an
exam table. Nelson lost consciousness
immediately following the phlebotomy, fell
off the table, and was found on the floor,
prone, bleeding from his head.
It’s not clear from the report whether
he fell during the blood draw, or after the
venipuncture (when he might have been
left alone).
A physician entered the room and performed a basic neurological exam. Because of concern about a cervical spine
injury, the physician implemented cervical
spine immobilization.
Thankfully, the patient did regain con-
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sciousness. However, once the patient regained consciousness, he complained of
tingling in his arms and legs. He was transported to a local hospital where he was diagnosed with a broken neck and spinal
cord injury.
It’s unclear from the reporting whether
his cord injury was complete or partial. It’s
also unclear at what level his quadriplegia/
quadriparesis starts. It does not matter in
terms of a lawsuit being filed. A lawsuit was filed and the plaintiff’s attorney argued that Nelson required nearly
$5M in economic damages alone, including
medical bills and lost wages. That’s before
any calculation on pain and suffering.
The legal argument made against the
defendant doctor was that it was foreseeable that venipuncture could trigger a fainting syncopal episode and the patient should
not have been placed in a sitting position
during the blood draw. The attorney argued
that his client should have been in a padded
chair that would prevent or cushion a fall. At
the very least, the patient should have been
lying in a supine position.
IS DR. DERM PROTECTED ?
Dr. Derm has always been very safety conscious, takes careful consent and is very
careful to practice in accordance with the
standard of care. He understands the concepts of duty and breach of duty, and he
has a well-trained staff.
Notwithstanding, a simple mistake by
his medical assistant may lead him to lose
a very large medical malpractice case. The
fact that his patient was a research patient,
who signed consent to be a research subject and who paid nothing for her treatment
(and was, in fact, paid to come for her study
visits) will not help defend Dr. Derm. DT
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U.S.A.
IMPORTANT INFORMATION ABOUT
®
Mirvaso
(Brimonidine) Topical Gel, 0.33%*
*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base
BRIEF SUMMARY
This summary contains important information about MIRVASO (Mer-VAY-Soe)
Gel. It is not meant to take the place of the full Prescribing Information.
Read this information carefully before you prescribe MIRVASO Gel. For full
Prescribing Information and Patient Information please see package insert.
WHAT IS MIRVASO GEL?
MIRVASO (brimonidine) Topical Gel, 0.33% is a prescription medicine that
is used on the skin (topical) to treat facial redness due to rosacea that does
not go away (persistent).
WHO IS MIRVASO GEL FOR?
MIRVASO Gel is for use in adults ages 18 years and older.
WHAT WARNINGS AND PRECAUTIONS SHOULD I BE AWARE OF?
MIRVASO Gel should be used with caution in patients that:
@
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will harm an unborn baby.
@ &6*'6*&78+**).3,8.7348034;3.+# *15&77*7.384'6*&782.10
You and your female patient should decide if she will use MIRVASO Gel or
breastfeed. She should not do both.
Ask your patient about all the medicines they take, including prescription
&3) 4:*68-*(4938*6 2*).(.3*7 70.3 564)9(87 :.8&2.37 &3) -*6'&1
supplements. Using MIRVASO Gel with certain other medicines may affect
each other and can cause serious side effects.
Keep MIRVASO Gel out of the reach of children.
If anyone, especially a child, accidentally swallows MIRVASO Gel, they
may have serious side effects and need to be treated in a hospital. Get
medical help right away if you, your patient, a child, or anyone else
swallows MIRVASO Gel and has any of these symptoms:
MIRVASO Gel can lower blood pressure in people with certain heart or
'144):*77*1564'1*27 **“What warnings and precautions should I be
aware of?”
These are not all of the possible side effects of MIRVASO Gel. Remind your
5&8.*38784(&11=49+462*).(&1&):.(*&'4987.)**++*(87
%49&6*&174*3(496&,*)846*54683*,&8.:*7.)**++*(874+56*7(6.58.43)69,7
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HOW SHOULD MIRVASO GEL BE APPLIED?
@ *2.3)=4965&8.*3878497*# *1*<&(81=&7=49.37869(88-*2
They should not use more MIRVASO Gel than prescribed.
@ &8.*3877-491)348&551=# *184.66.8&8*)70.34645*3;493)7
@ Important: MIRVASO Gel is for use on the face only. Patients should not
97*# *1.38-*.6*=*72498-46:&,.3&!-*=7-491)&174&:4.)
contact with the lips and eyes.
@ 37869(8=4965&8.*387847**8-*)*8&.1*)37869(8.437+46"7*8-&8(42*
with MIRVASO Gel for information about how to apply MIRVASO Gel
correctly.
GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF
MIRVASO GEL
Remind your patients not to use MIRVASO Gel for a condition for which it
;&734856*7(6.'*)&3)84348,.:*# *18448-*65*451**:*3.+8-*=
-&:*8-*7&2*7=25842782&=-&628-*2
WHAT ARE THE INGREDIENTS IN MIRVASO GEL?
Active Ingredient: brimonidine tartrate
Inactive Ingredients: carbomer homopolymer type B, glycerin,
2*8-=15&6&'*3 5-*34<=*8-&341 5645=1*3* ,1=(41 596.C*) ;&8*6 74).92
-=)64<.)*8.8&3.92).4<.)*
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT MIRVASO GEL?
@ 484www.mirvaso.com or call 1-866-735-4137
GALDERMA LABORATORIES, L.P.
468$468-!*<&7
" *:.7*)9,978
HCP
@ Lack of energy, trouble breathing or stops breathing, a slow heart beat,
confusion, sweating, restlessness, muscle spasms or twitching.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF MIRVASO GEL?
The most common side effects of using MIRVASO Gel include:
@ 6*)3*77D97-.3,'963.3,7*37&8.434+8-*70.370.3.66.8&8.43
0.3 6*)3*77 &3) D97-.3, 2&= -&55*3 &'498 84 -4967 &+8*6 &551=.3,
MIRVASO Gel. Ask your patients to tell you if they get skin redness and
D97-.3,8-&8.793(42+468&'1*
All trademarks are the property of their respective owners.
©2016 Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
14501 N. Freeway
Fort Worth, TX 76177
MIR-00030a Printed in USA 04/16
References: 1. Fowler J Jr, Jackson JM, Moore A, et al; Brimonidine Phase III
Study Group. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5%
for the treatment of moderate to severe facial erythema of rosacea: results of two
randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol.
2013;12(6):650-656. 2. Moore A, Kempers S, Murakawa G, et al; Brimonidine LTS
Study Group. Long-term safety and efficacy of once-daily topical brimonidine
tartrate gel 0.5% for the treatment of moderate to severe facial erythema of
rosacea: results of a 1-year open-label study. J Drugs Dermatol. 2014;13(1):56-61.

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