DermatologyTimesJune2015

CLINICAL 13
Acne in skin of color.
Acne vulgaris is the leading dermatologic diagno-
sis among the population of Americans collec-
tively referred to as people with skin of color
COSMETIC 22
Laser tattoo removal: rethinking ink.
Now available in three wavelengths, picosecond
lasers have made some of the toughest-to-treat
tattoo colors the easiest
ONCOLOGY 36
Targeted therapy and adoptive
T-cell therapy offer alternatives to
immunotherapy.
Treatment strategies for advanced melanoma
BUSINESS 46
9 strategies to prepare your practice
for ICD-10.
From the pages of Medical Economics:
Strategies to help you to prepare for October 1
THE TAKEAWAY 58
Sunscreen safety and
efficacy.
Dr. Norman Levine talks
with Dr. Darrell Rigel about
setting the record straight on
sunscreen ingredients and use
Clinical Analysis for Today’s Skincare Specialists June 2015 | VOL. 36, NO. 06 |
Shrinking double
chins without
surgery
Lisette Hilton | Staff Correspondent
In This Issue June 2015 VOL. 36, NO. 06
John Jesitus | Senior Staff Correspondent
Wound healing
P to promote wound
healing range from relatively straightfor-
ward drugs and debridement techniques
to meticulous manipulation of skin grafts
and donor sites, using techniques such as
laser-assisted application of mesenchymal
stem cells (MSCs), says an expert at Maui-
Derm 2015.
These new tools and techniques have
arisen from dermatologists’ ever-evolv-
ing concept of wound healing, says Rob-
ert S. Kirsner, M.D., Ph.D. He is chairman
(interim) and Harvey Blank Professor, De-
partmentofDermatology&CutaneousSur-
gery; professor of epidemiology and public
health; and director of the Wound Center
at the University of Miami Miller School of
Medicine.
In educating residents, his department
emphasizes that many of the conditions
theyseeactuallyinvolvewounds—though
they may not realize it. Along with chronic
skin ulcers, burns and traumatic injuries,
Dr. Kirsner explains, everything from can-
cers and inflammatory conditions to ge-
netic autoimmune diseases and drug reac-
tions presents with wounding.
Compared to general surgeons and plas-
tic surgeons, says Dr. Kirsner, “We create
WOUND HEALING see page 16
O A , the FDA approved deoxy-
cholic acid (Kybella, Kythera Biophar-
maceuticals)forthetreatmentofmoder-
ate-to-severesubmentalfatinadults.Ky-
bella is the first and only FDA-approved
submental contouring injectable drug,
accordingtoaKytherarelease.Thedrug
received unanimous advisory commit-
tee support earlier this year.
Helen M. Torok, M.D., medical direc-
tor, Trillium Creek Dermatology and
Surgery, Medina, Ohio, gives Kybella a
thumbs up.
“For those patients who are weary of
surgical procedures, this is truly a non-
SHRINK DOUBLE CHINS WITHOUT SURGERY see page 26
Cosmetic
Diverse tools and technique advances
A
C
E
B
D
As presented at MauiDerm 2015
A 43-year-old female developed a deep,
chronic wound after her heart transplant.
Figure A. April 2010 B. July 2010
C. A different angle, as of August 5, 2010
shows the depth of the wound.
D. At August 13, 2010, significant
improvement begins to be observed.
E. As of September 2, 2010, approximately
8 weeks’ treatment with topical timolol.
Photos: Robert S. Kirsner, M.D.
DermatologyTimes®
June2015Volume36No.06ClinicalAnalysisforToday’sSkincareSpecialistsDermatologyTimes.com
ES618881_DT0615_CV1.pgs 05.22.2015 23:11 ADVblackyellowmagentacyan

Harness the power
®/TMs are trademarks of Valeant Pharmaceuticals International, Inc., or its affiliates. Any other product or brand names and logos are the
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©2015 Obagi Medical, a division of Valeant Pharmaceuticals North America LLC.
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3JUNE 2015 ⁄ DERMATOLOGYTIMES.COM
EDITORIAL ADVISORY BOARD
Insight & Opinion From Our Advisory Board Leaders
W
e are entering a new era in
dermatology where numer-
ous drugs are available with
the sole purpose of improving appear-
ance and not treating disease. Certainly,
aging could be considered a disease
that affects all humans, but it is possible
to argue that since all humans age, it is
normal and not a disease.
Whether the appearance degrada-
tion of aging is normal or a disease, the
neurotoxins that are being used to treat
the condition are considered drugs and
are studied and examined for safety in
the same manner as all drugs designed
to treat disease. This is exemplified by
most recent draft guidance issued in
August 2014 by the FDA on Upper Facial
Lines: Developing Botulinum Toxin Drug
Products. This guidance states that for
a neurotoxin to be approved as effica-
cious, it must remove all motion in the
injection area receiving a rating in the
category of “none” or zero. While this
is quite desirable in the glabellar area,
where frowning is almost always con-
sidered an unattractive facial expres-
sion, it might not be desirable to elimi-
nate all movement around the eyes, a
common area of neurotoxin injection.
Many have observed that failure of skin
movement around the eyes when smil-
ing leads to the perception by others of
insincerity. Indeed, some contraction
of the skin around the eyes when smil-
ing is normal since the lower eye con-
tracts simultaneously with the corner of
the mouth, which produces lifting of the
mouth corner and smiling.
NEED FOR NEW CRITERIA
Dermatologic drugs are studied on an
ordinal scale of 0 to 4 where 0 = clear,
1 = almost clear, 2 = mild, 3 = moderate,
and 4 = severe. This scale works quite
well for the evaluation of acne or psoria-
sis medications where clear or almost
clear is the standard by which excellent
drugs should be judged. I am not sure
this same scale works for the evalua-
tion of new neurotoxins hoping for ap-
proval. It might be that the reduction of
periorbital movement and wrinkling from
moderate to mild would be superior to
the reduction of periorbital wrinkling
from moderate to none. No movement is
not aesthetically pleasing and aesthetic
assessment is a much different realm
than drug treatment success.
There is a need for new evaluation
criteria for drugs that function in the
aesthetic realm. The same ordinal scale
can be used, but the ordinal rating
required for success and subsequent
drug approval must be reconsidered.
With neurotoxins, wrinkles in some loca-
tions are good while wrinkles in other
locations are bad. Foreheads that are
shiny and eyebrows that cannot elevate
are dead giveaways that chemodener-
vation is at work. As a matter of fact,
the difference in appearance from the
totally paralyzed forehead 1 week after
injection to the partially moving fore-
head 2 months after injection to the total
moving forehead 3 months after injec-
tion eliminates any doubts that the ap-
pearance change is natural. It is obvious
that neurotoxins are at work!
There is certainly something to be
said for projecting natural good looks
as opposed to the sometimes contorted
appearance created by neurotoxins.
Using some neurotoxins that eliminate
movement and others that simply de-
crease movement could sculpt a more
natural appearance. For example, it
would be beneficial to paralyze the
frown with an aggressive toxin appli-
cation, but the fine lines on the lateral
cheeks that appear with smiling could
be softened with a milder toxin effect.
I liken the facial use of neurotoxins to
painting a portrait. Using oil pigments
on canvas to capture the essence of
a beautiful face takes more than one
brush. Imagine if Leonardo da Vinci
used one large brush to paint the Mona
Lisa! The outcome would have been
much different. Similarly, the dermatolo-
gist artist crafting a beautiful face also
needs more than one toxin with different
degrees of denervation to achieve suc-
cess.
I think cosmetic dermatology must
revisit the “none” or “almost none”
phenomenon for treatment success.
None or almost none has tremendous
importance when addressing drugs
where success is defined as cure. It
is not really possible to cure wrinkles
other than by early death, which clearly
would not defined as treatment suc-
cess. Perhaps for drugs that address
appearance issues, a new ordinal static
scale should be developed that is
clinically meaningful from an aesthetic
standpoint. DT
Cosmetic dermatology and the
‘none’ or ‘almost none’ phenomenon
It is not really
possible to cure
wrinkles other
than by early death,
which clearly would
not be defined as
treatment success...
a new ordinal static
scale should be
developed.
Zoe Diana Draelos, M.D.,
is a clinical and research dermatologist
with Dermatology Consulting Services,
High Point, N.C. and a consulting
professor of dermatology, Duke University
School of Medicine, Durham, N.C.
ES615717_DT0615_003.pgs 05.19.2015 21:25 ADVblackyellowmagentacyan

®
JUNE 2015 ⁄ DERMATOLOGYTIMES.COM
4 EDITORIAL ADVISORY BOARD
Let your voice be heard, contact us: editor@dermatologytimes.com
DermatologyTimesistheonlyclinicalnewsresourceserving
areadershipofmorethan14,000dermatologistsandother
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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.
Dr. Joel
Schlessinger
Omaha, Neb.
Dr. James
Spencer
St. Petersburg, Fla.
Dr. Helen
Torok
Medina, Ohio
Dr. Philip
Werschler
Spokane, Wash.
Dr. Albert
Yan
Philadelphia, Pa.
Dr. Tina
Alster
WashingtonD.C.
Dr. Seth
Matarasso
San Francisco, Calif.
Dr. Patti
Farris
New Orleans, La.
Dr. Roy
Geronemus
New York, N.Y.
Dr. David
Goldberg
New York, N.Y.
Dr. Ranella
Hirsch
Boston, Mass.
Zoe Diana Draelos, M.D.,
is consulting professor
of dermatology,
Duke University School
of Medicine, Durham, N.C.
Norman Levine, M.D.,
is a private practitioner
in Tucson, Ariz.
Ronald G. Wheeland, M.D.,
is a private practitioner
in Tucson, Ariz.
Elaine Siegfried, M.D.,
is professor of pediatrics &
dermatology, Saint Louis
University Health Sciences
Center, St. Louis, Mo.
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References: 1. Stein Gold L, Kircik L, Fowler J, et al; Ivermectin Phase III Study Group. Efficacy and safety of ivermectin 1% cream
in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs
Dermatol. 2014;13(3):316-323. 2. Data on file. Galderma Laboratories, L.P. 3. Taieb A, Ortonne JP, Ruzicka T, et al; Ivermectin
Phase III Study Group. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of
rosacea: a randomized, investigator-blinded trial. Br J Dermatol. In press.
All trademarks are the property of their respective owners.
©2015 Galderma Laboratories, L.P.
Galderma Laboratories, L.P. 14501 N. Freeway, Fort Worth, TX 76177 IVM-143B Printed in USA 02/15
BRIEF SUMMARY
This summary contains important information about
SOOLANTRA (soo lan’ trah) Cream. Read this information carefully
before you prescribe SOOLANTRA Cream. For full Prescribing
Information and Patient Information please see the package insert.
WHAT IS SOOLANTRA CREAM?
SOOLANTRA Cream is a topical prescription medicine indicated for the
treatment of the inflammatory lesions of rosacea.
WHO IS SOOLANTRA CREAM FOR?
SOOLANTRA Cream is indicated for people with inflammatory lesions
of rosacea. It is not known if SOOLANTRA Cream is safe and effective
for children. Advise your patients to not use SOOLANTRA Cream for a
condition for which it was not prescribed and remind them to not give
SOOLANTRA Cream to other people, even if they have the same symptoms
as it may harm them.
WHAT SHOULD I ASK MY PATIENTS BEFORE PRESCRIBING
SOOLANTRA CREAM?
Before you prescribe SOOLANTRA Cream, ask your patients if they:
A have any other medical conditions.
A &6* 46*,2&28 36 40&22.2, 83 '*(31* 46*,2&28 8 .7 238 /23;2 .+
SOOLANTRA Cream can harm an unborn baby.
A are breastfeeding or plan to breastfeed. It is not known if
SOOLANTRA Cream passes into breast milk and if it can harm a baby.
WHAT ARE THE MOST COMMON SIDE EFFECTS OF
SOOLANTRA CREAM?
The most commonly reported side effects when using SOOLANTRA Cream
include skin burning sensation and skin irritation. Remind your patients to
tell you if they have any side effect that bothers them or that does not go
away. These are not all of the possible side effects of SOOLANTRA Cream.
For more information, see the full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to
the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also
contact GALDERMA LABORATORIES, L.P. AT 1-866-735-4137.
HOW SHOULD PATIENTS USE SOOLANTRA CREAM?
A SOOLANTRA Cream is for use on the face only and should not be used in
the eyes, mouth, or vagina.
A SOOLANTRA Cream should be applied to the affected areas of the face
once a day.
APPLYING SOOLANTRA CREAM:
A A pea-sized amount of SOOLANTRA Cream should be applied to each
area of the face (forehead, chin, nose, each cheek) that is affected.
Avoid contact with the lips and eyes.
SOOLANTRA Cream is supplied in a child-resistant capped tube.
A To open, gently press down on the child resistant cap and twist
counterclockwise. To avoid spilling, do not squeeze the tube while
opening or closing.
A To close, gently press down on the child resistant cap and twist
clockwise.
WHAT ARE THE INGREDIENTS IN SOOLANTRA CREAM?
Active ingredient: ivermectin. Inactive ingredients: carbomer copolymer
type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate
disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol,
phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol,
propylparaben, purified water, sodium hydroxide, sorbitan monostearate,
and stearyl alcohol.
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT
SOOLANTRA CREAM?
A This Brief Summary summarizes the most important information
about SOOLANTRA Cream. For full Prescribing Information and
Patient Information please see the package insert.
A 3 83 www.soolantra.com or call 1-866-735-4137
Trademarks are the property of their respective owners.
GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA
Revised: December 2014
IMPORTANT INFORMATION ABOUT
SOOLANTRA®
(ivermectin) Cream, 1%

LEGALEAGLE
D
r. Derm is a hard working der-
matologist practicing in a city
that has yet to fully recover from
the recession. Overhead is up and reve-
nues are down. He is left with no choice
but to start terminating some employ-
ees. He has 22 employees. He evaluates
his employees and finds that they all per-
form well. However, he is aware that a
particular 27-year-old bulimic employee
takes continuous breaks to eat small por-
tions of food followed by prolonged bath-
room breaks. Dr. Derm is annoyed with
this behavior, feels it is disruptive to the
work environment, and has decided it
interferes with patient-staff flow. He termi-
nates this employee.
Before long he is served with a law
suit. His former employee alleges that she
was terminated for behaviors related to
her bulimia. In the lawsuit, she contends
that her eating behavior was protected
under the Americans with Disabilities Act.
Dr. Derm is now devastated. In his at-
tempt to lessen the financial burdens of
his practice, he ends up with a lawsuit. He
seeks legal help. What is the Americans
with Disabilities Act? Will Dr. Derm lose
this lawsuit?
ADA GENERAL LEGAL FRAMEWORK
The Americans with Disabilities Act of
1990 (ADA) provides a general legal frame-
work for access of individuals with disabili-
ties to public places and also for accom-
modating employees with disabilities in
the workplace. Although the ADA contains
very specific guidance for physical accom-
modations, such as wheelchair access, it
provides little guidance relevant to workers
with conditions such as diabetes.
The employment provision of the ADA
applies to employers who have 15 or
more employees. The gist of the ADA is
that it bans discrimination against a “qual-
ified individual with a disability.” This is
defined as “an individual with a disabil-
ity who, with or without reasonable ac-
commodation, can perform the essential
functions of the employment position that
such an individual holds or hires.” The
ADA also prohibits discrimination based
on a perceived disability; that is, when the
employer wrongly assumes an employee
cannot do a job because of a disability. If
employees are fired for legitimate work-
related reasons, there cannot be an ADA
claim, even if the employee happens to
also have disability.
The ADA defines disability as: “(A) a
physical or mental impairment that sub-
stantially limits one or more of the major
life activities of such an individual; (B) a
record of such impairment; (C) being re-
garded as having such impairment.” The
disability must also last at least 6 months,
and not be a natural, self-limited condition
such as pregnancy.
The ADA does not protect those who
engage in illegal use of drugs or the use
of alcohol in the workplace. Employees
with substance abuse problems may be
held to the same standard of behavior as
other employees. However, those who
have successfully completed a rehabili-
tation program for drugs, or who are cur-
rently enrolled in a program and not cur-
rently using drugs, are protected. Of note,
courts have differed on whether alcohol-
ism itself is a disability. Some federal cir-
cuit courts say alcoholism is a disability,
but others have ruled that it is not.
IS BULIMIA A DISABILITY UNDER THE ADA?
Better asked, does bulimia fit under the
ADA requirement as an impairment that
substantially limits a major life activity?
In general, courts look at this definition
quite closely. In Bragdon v. Abbott, the
United States Supreme Court considered
whether an asymptomatic disease — HIV
— could be a disability under the ADA.
The plaintiff’s dentist refused to fill a cav-
ity in the plaintiff’s tooth in his office, as-
serting that he did not have sufficient in-
fection control equipment. The lawsuit
was brought under the public facilities
section of the ADA, but the test for dis-
ability is the same as in the employment
section.
The Supreme Court first inquired into
whether asymptomatic HIV infection was
an impairment. The court held that the pro-
found effects of HIV on the immune sys-
tem qualify as an impairment, without re-
quiring that the impairment produce symp-
tomatic disease. The same ruling might
apply to an asymptomatic bulimic — buli-
mia being a complex disease that might ul-
timately impact many organ systems.
Having found that HIV is an impair-
ment, the Court then asked whether the
impairment could substantially limit a
major life activity though not yet causing
symptomatic illness. The court found that
being infected with HIV would affect deci-
sions about one’s major life activities and,
in this plaintiff’s case, would affect the de-
cision to have children. The same analy-
sis might apply to a 27-year-old bulimic’s
concern of the impact of this disease on
her having and raising children.
Nevertheless, in Salim v. MGM Grand
Detroit, L.L.C., the court rejected the
claim of a person with diabetes as being
substantially limited in working, thinking
and taking care of herself, noting that not
being able to perform a job during a par-
ticular time (i.e., time needed to eat) does
not rise to the level of being substantially
limited in the major life activity of working.
Conversely, in Lawson v. CSX Transporta-
tion, Inc., the court determined that a jury
could reasonably find the plaintiff sub-
stantially limited in the major life activity of
eating as a result of his diabetes severely
restricting what and when he could eat.
It is totally understandable that in dif-
ficult economic times, Dr. Derm wants to
cut back on his staff. If his employees do
not have a contract of employment, he
can terminate an employee at will. How-
ever, when he terminated his employee
for her bulimia, he allowed himself the po-
tential to be sued in violation of the ADA.
A long, expensive trial with an ultimate
jury decision may ensue. DT
David 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.
I have been sued under the ADA

®
10 IRREGULARBORDER
R
esveratrol is a naturally occur-
ring polyphenolic antioxidant
found in over 70 plant species.
Common sources include grapes, pea-
nuts and ripe berries. In nature, res-
veratrol serves to protect plants from
ultraviolet light, infections and other
environmental stressors. Resveratrol is
best known as the longevity molecule
since scientific studies have demon-
strated that resveratrol extends lifespan
in a variety of animal species.1
The life-extending benefits of resver-
atrol are attributed to the fact that, like
caloric restriction, resveratrol modulates
sirtuin gene expression.2
Sirtuins are a
group of enzymes that influence impor-
tant adaptive functions such as cell
survival, DNA repair, gluconeogenesis,
cell-cycle regulation, insulin sensitivity,
lipid metabolism and fat mobilization.3
In addition to extending lifespan, res-
veratrol has been touted to improve
healthspan. Accordingly, resveratrol has
been studied in almost all fields of med-
icine and has significant potential value
for treating a variety of disease states.
Beneficial effects include neuroprotec-
tion, cardioprotection, anti-diabetic and
anti-tumor activity.4
Resveratrol also has broad anti-
inflammatory effects and inhibits a
variety of inflammatory markers includ-
ing cox-2, IL-2, IL-6, IL-8 and vascu-
lar endothelial growth factor.5
Ongoing
studies are being conducted to confirm
the health benefits of resveratrol.
PHARMACOKINETICS OF RESVERATROL
The clinical use of resveratrol has been
limited by the challenges of oral admin-
istration.6
Although 70% of orally admin-
istered resveratrol is absorbed, it is rap-
idly metabolized to glucuronide and sul-
fated forms. Even after large oral doses,
only trace amounts of resveratrol can be
detected in the bloodstream. The health
effects of the glucuronide and sulfated
derivatives of resveratrol are yet to be
determined.
Topical formulation with resveratrol is
equally challenging. Resveratrol readily
isomerizes to the less desirable “cis”
form when exposed to ultraviolet light.7
Another challenge is that resveratrol is a
hydrophobic molecule, with a water sol-
ubility estimated at 0.05 mg/mL, making
it difficult to stabilize in meaningful con-
centrations in formulation.8
In view of
these challenges, it is not surprising that
few high concentration formulations of
resveratrol have been commercialized.
SKIN AGING AND RESVERATROL
Oxidative stress is known to contrib-
ute to skin aging. Free radicals are
produced as we age naturally and by
extrinsic factors such as ultraviolet
light, pollution and cigarette smoking.9
Reactive oxygen species (ROS) ac-
cumulate in cells where they damage
lipid membranes, proteins and DNA.
Free radicals upregulate transcrip-
tion factor activator protein 1 (AP-1)
that turns on the synthesis of colla-
gen digesting matrix metalloprotein-
ases, reduces collagen content in skin
and contributes to skin wrinkling. Oxi-
dative stress also upregulates nuclear
factor kappa beta (NF-kB), increasing
the synthesis of a variety of inflamma-
tory mediators that contribute to skin
aging. For these reasons, the use of
topical and systemic antioxidants are
of value for prevention of skin aging.
Resveratrol is unique among anti-
oxidants in that it functions as an anti-
oxidant in several ways.10
It serves as a
free radical scavenger that effectively
quenches reactive oxygen species such
as hydroxyl, superoxide and metal-
induced radicals.
Patricia K. Farris, M.D.
is owner of Old Metairie Dermatology,
Metairie, La., Clinical Associate Professor at
Tulane University, and editor of the textbook
Cosmeceuticals and Cosmetic
Practice.
Resveratrol, the
longevity molecule
Resveratrol works synergistically
with vitamin E to stabilized cell mem-
branes and prevent lipid peroxida-
tion. Finally, resveratrol acts through
the Nrf-2 pathway to promote synthe-
sis of endogenous antioxidants includ-
ing hemoxygenase 1, superoxide dis-
mutase and catalase. A recent study
has provided some of the first evi-
dence that a topical resveratrol formu-
lation can activate endogenous antiox-
idant production via the Nrf2 pathway
in human skin.11
Thus, resveratrol is
unique among antioxidants in its ability
to boost intrinsic antioxidant capacity.
Because of its chemical structure,
resveratrol is a member of the stilben-
oid group of polyphenols. Like the syn-
thetic estrogen diethylstilbesterol, res-
veratrol has phytoestrogenic effects and
is an estrogen beta receptor agonist.12
It is known that estrogen replacement
therapy in post-menopausal women can
mitigate at least some of the collagen
loss that is synonymous with advancing
age. Thus, resveratrol is of interest as
an estrogen alternative that can provide
the skin benefits of estrogen without the
side effects. Stilbene polyphenols can
also inhibit tyrosinase and lighten hy-
perpigmentation that is common in ac-
tinically damaged skin.
SKIN AGING AND MITROCHONDRIAL
OXIDATIVE STRESS
The role of mitochondrial oxidative stress
in skin aging has been reviewed by Krut-
mann and Schroeder.13
It is known that
RESVERATROL see page 34
Scientificstudies
havedemonstrated
thatresveratrol
extendslifespan
inavarietyof
animalspecies.

Topicort®
(desoximetasone cream USP) 0.05% and
Topicort®
(desoximetasone ointment USP) 0.05% are
indicated for the relief of the inﬂammatory and pruritic
manifestations of corticosteroid-responsive dermatoses.
Topicort®
(desoximetasone cream USP) 0.05% and Topicort®
(desoximetasone ointment USP) 0.05% are contraindicated
in those patients with a history of hypersensitivity to any of
the components of the preparation.
Important Safety Information
The following local adverse reactions are reported infrequently
with topical corticosteroids, but may occur more frequently with
the use of occlusive dressings. These reactions are listed in an
approximate decreasing order of occurrence: Burning, itching, irritation,
dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation,
perioral dermatitis, allergic contact dermatitis, maceration of the skin,
secondary infection, skin atrophy, striae, and miliaria. Because of the potential
for systemic absorption, use of topical corticosteroids may require that patients be
periodically evaluated for HPA axis suppression.
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis suppression and Cushing’s syndrome than
mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and
intracranial hypertension have been reported in pediatric patients receiving topical
corticosteroids. Administration of topical corticosteroids to pediatric patients should be
limited to the least amount compatible with an effective therapeutic regimen. Chronic
corticosteroid therapy may interfere with the growth and development of pediatric
patients. Before prescribing, please see brief Prescribing Information
on reverse side.
References: 1. Topicort®
Cream 0.05% Prescribing Information. Taro
Pharmaceuticals U.S.A., Inc. 2. Topicort®
Ointment 0.05% Prescribing Information.
Taro Pharmaceuticals U.S.A., Inc.
1,2
®
a division of Taro Pharmaceuticals U.S.A., Inc.
3 Skyline Drive, Hawthorne, NY 10532
www.taropharma.com
TaroPharma®
and Topicort®
are registered trademarks of Taro Pharmaceuticals U.S.A., Inc.
AD100-0037 © 2015 Taro Pharmaceuticals U.S.A., Inc. May 2015

Topicort®
(Desoximetasone Cream USP) 0.05% Rx only
Topicort®
(Desoximetasone Ointment USP) 0.05% Rx only
Brief Summary of Prescribing Information. For complete prescribing information
For topical use only. Not for oral, ophthalmic, or intravaginal use.
INDICATIONS AND USAGE
Topicort®
(desoximetasone cream USP) 0.05% and Topicort®
(desoximetasone
manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparation.
WARNINGS
Keep out of reach of children.
PRECAUTIONS
General
Systemic absorption of topical corticosteroids can produce reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for
upon withdrawal of the topical corticosteroid.
Because of the potential for systemic absorption, use of topical corticosteroids
may require that patients be periodically evaluated for HPA axis suppression.
Factors that predispose a patient using a topical corticosteroid to HPA axis
suppression include the use of more potent steroids, use over large surface
areas, use over prolonged periods, use under occlusion, use on an altered skin
barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis
suppression. If HPA axis suppression is documented, an attempt should be
made to gradually withdraw the drug, to reduce the frequency of application, or
require supplemental systemic corticosteroids. Recovery of HPA axis function is
generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus
can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may
increase the total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of
topical corticosteroids.
Local Adverse Reactions with Topical Corticosteroids
Local adverse reactions may be more likely to occur with occlusive use, prolonged
useoruseofhigherpotencycorticosteroids.Reactionsmayincludeatrophy,striae,
telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions,
hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary
infection, and miliaria. Some local adverse reactions may be irreversible.
Allergic Contact Dermatitis with Topical Corticosteroids
Allergic contact dermatitis to any component of topical corticosteroids is
usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical
Concomitant Skin Infections
Concomitant skin infections should be treated with an appropriate antimicrobial
agent. If the infection persists, Topicort®
(desoximetasone cream USP) 0.05%
or Topicort®
(desoximetasone ointment USP) 0.05% should be discontinued
until the infection has been adequately treated.
Information for the Patient
Patients using topical corticosteroids should receive the following information
and instructions:
1. This medication is to be used as directed by the physician. It is for external
use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other
than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or
wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions, especially under
occlusive dressings.
5. Other corticosteroid-containing products should not be used with Topicort®
(desoximetasone cream USP) 0.05% or Topicort®
(desoximetasone ointment
As with other corticosteroids, therapy should be discontinued when control is
achieved. If no improvement is seen within 4 weeks, contact the physician.
Laboratory Tests
The following tests may be helpful in evaluating the hypothalamic-pituitary-
adrenal (HPA) axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic
Desoximetasone was nonmutagenic in the Ames test.
Corticosteroids have been shown to be teratogenic in laboratory animals when
administered systemically at relatively low dosage levels. Some corticosteroids
havebeenshowntobeteratogenicafterdermalapplicationinlaboratoryanimals.
Desoximetasone has been shown to be teratogenic and embryotoxic in mice,
rats, and rabbits when given by subcutaneous or dermal routes of administration
in doses 15 to 150 times the human dose of Topicort®
(desoximetasone cream
USP) 0.05%, or Topicort®
(desoximetasone ointment USP) 0.05%.
There are no adequate and well-controlled studies in pregnant women on
®
(desoximetasone cream USP) 0.05% or Topicort®
(desoximetasone ointment
the potential risk to the fetus. Drugs of this class should not be used extensively on
pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers
It is not known whether topical administration of corticosteroids could result in
Systemicallyadministeredcorticosteroidsaresecretedintobreastmilkinquantities
be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis suppression and Cushing’s syndrome than
mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome,
and intracranial hypertension have been reported in pediatric patients receiving
topical corticosteroids. Manifestations of adrenal suppression in pediatric
patients include linear growth retardation, delayed weight gain, low plasma
cortisol levels, and absence of response to ACTH stimulation. Manifestations of
intracranial hypertension include bulging fontanelles, headaches, and bilateral
papilledema.
Administration of topical corticosteroids to pediatric patients should be limited
corticosteroid therapy may interfere with the growth and development of
pediatric patients.
ADVERSE REACTIONS
The following local adverse reactions are reported infrequently with topical
corticosteroids, but may occur more frequently with the use of occlusive
dressings. These reactions are listed in an approximate decreasing order of
occurrence:
Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform
eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis,
maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
In controlled clinical studies the incidence of adverse reactions were low 0.8%
for Topicort®
(desoximetasone cream USP) 0.05% and included pruritus,
erythema, vesiculation, and burning sensation. The incidence of adverse
reactions was low (0.2%) for Topicort®
(desoximetasone ointment USP) 0.05%
and included mild burning sensation at the site of application.
OVERDOSAGE
PRECAUTIONS).
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne,
NY 10532
Topicort®
and TaroPharma®
are registered trademarks of Taro Pharmaceuticals
FDA. Visitwww.fda.gove/Safery/MedWatch/default.htm, or call 1-800-FDA-1088.
Issued: April 2014
ES615015_DT0615_012_FP.pgs 05.16.2015 02:43 ADVblack

CLINICAL DERMATOLOGY
14
21GENITAL HERPES PREVENTION
Vaccine with deleted glycoprotein shows
promising results
TATTOOS MAY STOP APPLE WATCH
Light-absorbing quality of tattoo ink keeps
popular device from functioning properly
A is the leading derma-
tologic diagnosis among the popula-
tionofAmericanscollectivelyreferred
to as people with skin of color: Afri-
canAmericans,Hispanics/Latinosand
Asians/PacificIslanders.1
Dermatolo-
gist Andrew F. Alexis,
M.D., M.P.H., who re-
ported that finding in
the June 2014 Journal
of Drugs in Dermatol-
ogy, also conducted a
comparativestudyathis
Skin of Color Center in
NewYorkCityandfoundthatacnewas
theleadingdiagnosisinAfricanAmer-
icans, Hispanic/Latinos and Cauca-
sians.2
Skin of color patients exhibit
clinical and therapeutic nuances that
affect acne management. Dermatol-
ogists should understand how these
patients present, clinically; how to
treatthemsafely;culturalfactors;and
their specific desired treatment end-
points. Dr. Alexis, who is dermatol-
ogychairatMountSinaiSt.Lukesand
MountSinaiRoosevelt,NewYork,N.Y.,
presentedonacneandrosacea inskin
of color during the May 2015 Skin of
Color Seminar in New York City.
WHAT DERMATOLOGISTS SHOULD KNOW
These are distinct features of acne in
patients with skin of color, according
toDr.Alexis:skinofcoloracnepatients
haveatendencytodeveloppostinflam-
matory hyperpigmentation, which is
frequently of equal or greater concern
to the patient as the acne itself. They
have a higher risk than Caucasian pa-
tients of keloids or hypertrophic scars
arising at sites of moderate-to-severe
acne.Thescarsareespeciallylikelyon
the chest and back. Cultural practices
in patients with skin of color may in-
crease acne risk. Many African Amer-
icans, for example, use hair products
that contain oils, which can be come-
dogenic and produce “pomade acne,”
he says. Another example: the use of
cocoabutteriscommonpracticeamong
African Americans, who hope to im-
prove their complexions. “[There is a]
widely held but unproven belief that
cocoa butter evens the skin tone,” Dr.
Alexis says. “This can, in turn, exac-
erbate acne because of its comedog-
enic nature.”
LATEST RESEARCH FINDINGS
Because of higher risks of pigmentary
abnormalitiesamongpatientswithskin
of color, dermatologists should eval-
uate the safety of topical acne prod-
ucts that might irritate the skin before
“With the SGR charade behind us, physicians have
an added measure of practice stability that will
enable us to more closely focus on meaningful
physician payment and delivery reforms that
facilitate access to high quality patient care...
Dermatology patients can also breathe a little
easier today, knowing that the bill also alleviates
additional co-pays for surgical or procedural follow-
up care. It was unconscionable that under a previ-
ously established policy, patients would have to open
their wallets to simply have their stitches out. Not only
is this bill good policy, it’s the right thing for patients.”
Mark G. Lebwohl, M.D., AAD President
SOURCE: HTTP://BIT.LY/PAYMENTFORMULA
ACNE IN SKIN OF COLOR see page 14
Acne in skin of color
LISETTE HILTON | STAFF CORRESPONDENT
It turns out, the more you
debride, the better... If
you had a sort of molecu-
lar scalpel, you could
debride right to that edge
and get to the tissue that’s
capable of healing.”
Robert S. Kirsner, M.D., Ph.D.
MauiDerm 2015
Wound Healing
See story page 1
QuotableDTExtra
Dr. Alexis
Keloid scarring on the chest
Photo: Andrew F. Alexis, M.D.

®
14 CLINICAL DERMATOLOGY
recommending patients use them, Dr.
Alexissays.“Fortunately,therehavebeen
studiesofthemajortopicalagentsthat
have specifically looked at tolerability
andoverallsafetyinpatientswithhigher
Fitzpatricktypes.Theseincluderecent
studiesofadapalene0.1%-benzoylper-
oxide 2.5% gel in black patients3
… and
dapsonegel,5%inadultskinofcolorfe-
males with facial acne vulgaris, which
waspresentedattheSkinofColorSem-
inar Series annual meeting,” he says.
TREATING SKIN OF COLOR ACNE PATIENTS
Controlling inflammation associated
with acne is paramount in skin of color
patients, given the higher risk for long
lasting sequelae, such as postinflam-
matory hyperpigmentation and, in se-
vere cases involving the trunk, keloids,
Dr.Alexissays.“Thiscanbeachievedby
carefulselectionofwell-toleratedandef-
fectiveagentsthathaveanti-inflamma-
tory effects relevant to acne. These in-
clude topical retinoids [especially ada-
palene],topicaldapsoneand,indirectly,
topicalbenzoylperoxide,whichinhibits
P. acnes — an important driver of in-
flammationinacne,”hesays.“Italsoin-
cludes oral tetracyclines,” doxycycline
and minocycline, in particular.
BEST PRACTICES
Itmightbeintuitivefordermatologists
toundertreatskinofcoloracnepatients
because of the risks of hyperpigmen-
tation and scarring. But that’s not the
right approach. In fact, Dr. Alexis says,
undertreatingskinofcolorpatientswith
acnecouldleadtomoreseverepostin-
flammatoryhyperpigmentation.And,in
thecaseofmoderate-to-severetruncal
acne,undertreatmentcouldincreasethe
riskofhypertrophicorkeloidscarring.
“Carefully select efficacious, but well
tolerated topical regimens such that ir-
ritationisavoided[sincethiscaninduce
pigment alterations]. Examples of well-
tolerated agents are those with well-for-
mulated vehicles, such as aqueous gels
and creams [as opposed to ethanolic
gels, which are more drying and poten-
tiallyirritating],”hesays.“Startingretin-
oidsatalowerconcentration,thenwork-
ing upward over time is a good strategy
toensuretolerability.Usingbenzoylper-
oxideatconcentrationsof2.5-5%ispre-
ferred over higher concentrations. Mi-
cronized or micro-dispersed formula-
tions are also better tolerated.” DT
Disclosure: Dr. Alexis is an investigator for Allergan
and a consultant or advisory board member with
Allergan, Bayer, Galderma and Valeant.
References:
1. Alexis AF. Acne vulgaris in skin of color: under-
standing nuances and optimizing treatment out-
comes. J Drugs Dermatol. 2014 Jun;13(6):s61-5.
2. Callender VD, Alexis AF, Daniels SR, Kawata AK,
Burk CT, Wilcox TK, Taylor SC. Racial differences in
clinical characteristics, perceptions and behaviors,
and psychosocial impact of adult female acne. J
Clin Aesthet Dermatol. 2014 Jul;7(7):19-31.
3. Alexis AF, Johnson LA, Kerrouche N, Callender VD.
A subgroup analysis to evaluate the efficacy and
safety of adapalene-benzoyl peroxide topical gel in
black subjects with moderate acne. J Drugs Der-
matol. 2014 Feb;13(2):170-4.
ACNE IN SKIN OF COLOR:
Clinical and therapeutic nuances from page 13
Acne with postinflammatory
hyperpigmentation Photo: Andrew F. Alexis, M.D.
Controlling
inflammation
associated with
acne is paramount
in skin of color
patients.
P toconvincetheirteen-
ager not to get a tattoo might try this:
GivetheteenanAppleWatchandpass
along the following news.
According to a CNN report, some
Apple Watch wearers say their wrist
tattoos prevent the device’s heart-rate
sensorfromfunctioningproperly.And
since the Apple Watch uses the wear-
er’s heart rate to determine whether
thedeviceisbeingworn,awearerwho
has wrist tattoos might not be able to
placecalls,receivenotificationsoruse
certain apps.
TattooedAppleWatchwearershave
complained about the issue on social
media, and Apple blog iMore con-
firmed that the problem does indeed
exist.
AccordingtoCNN,thewayinwhich
the Apple Watch senses the wearer’s
heartbeat causes the problem. Apple
says the back of the device flashes
green and infrared light at the wear-
er’s skin, and the light is absorbed or
reflectedbytheblood.Whentheheart
pumps more blood to the wrist area,
the device senses it, and it also senses
the diminished amount of blood be-
tween beats. The Apple Watch calcu-
latesthewearer’sheartratebysensing
the timing between heartbeats.
Solid-colored tattoos — especially
red ones — also absorb the green
light and reflect the red light. Black
tattoos, which absorb both green and
red light, can also interfere with the
AppleWatch’sheart-ratesensor.Dark-
coloredskin,scarsandskinabrasions,
which are translucent, don’t interfere
withthedevice’sheart-ratesensor.Tat-
too ink is opaque, however, and pre-
vents light from penetrating the skin.
CNN reports that users have found
thatturningofftheAppleWatch’swrist
detection function allows notifica-
tions to come in, but it also prevents
the wearer from using the Apple Pay
function and receiving calls. DT
Tattoos may stop Apple Watch
BILL GILLETTE | STAFF CORRESPONDENT

Unilever is a pioneer in creating great products and brands.
What truly sets us apart is that we have spent decades cultivating our expertise
in caring for the stratum corneum (SC)—from scalp to toe—and, at the same time,
designing products that millions of people truly enjoy using every day.
With over 20,000 patents and patent applications, Unilever has always been
at the forefront of scientific breakthroughs—from the discovery of the
filaggrin protein and its role in creating natural moisturizing factor (NMF),
to the novel combination of ultra-mild surfactants like Directly
Esterified Fatty Isethionate (DEFI) and glycinate, that help preserve both
SC proteins and lipids during cleansing—all while exceeding consumer
expectations. Our journey continues, with a deep commitment to
measuring product effects across the entire SC, helping rebuild skin
with brands and innovations you and your patients will love.
Science that leads the way.
Products that capture the heart.
© 2015 Unilever 810899
Dove is a Registered Trademark

®
threetosixtimesasmanywoundsthat
we must repair. So we should know
how to take care of those wounds.”
To that end, Dr. Kirsner suggests
viewing wounds along a continuum
of healing outcomes. Between nor-
mal healing and chronic wounds lies
a wide spectrum of abnormal healing.
TheHolyGrail,hesays,isscarlessheal-
ing,asoccursinfetusesduringthefirst
two trimesters of gestation.
STIFLING STRESS REACTIONS
Indirectly,stressorssuchasanxiety,isola-
tionandevenpostoperativepaincanre-
ducewound-healingratesupto40%.1
Such
stressors release steroids, which stimu-
latethepituitarytoreleaseglucocorticoid
hormones.Thesehormonesdiminishthe
amountofpro-healingcytokines,suchas
interleukin (IL)-1, vascular endothelial
growth factor (VEGF) and transforma-
tive growth factor beta (TGFb), availa-
bletoreachthewound,Dr.Kirsnersays.
Conversely, he says, physical and
mental exercise, a positive attitude,
social interaction and pain reduction
all reduce stress, mediated by oxy-
tocin. “Someday perhaps we’ll be giv-
ing oxytocin to reduce stress and im-
prove healing.” For now, “consider cre-
ating a stress-free environment for our
patients.” This can include controlling
operative and postoperative pain, he
says, and perhaps postponing elective
proceduresifpatientshaverecentlyex-
perienced stressful life events.
Like steroids, catecholamines re-
leased during stress also delay healing.
Dr. Kirsner says that the success of sys-
temicpropranololinreducingchildhood
hemangiomas2
fueledthediscoverythat
beta blockers block catecholamines —
a mechanism that’s proving useful in
manyindications.Forinstance, inaran-
domized, controlled trial with 79 burn
patients, those who received a systemic
beta blocker healed faster (16.13 ± 7.4
days versus 21.52 ± 7.94 days, P = 0.004)
than control-group patients.3
The first use of beta blockers in heal-
ing chronic wounds involved a 43-year-
old female with a persistent open surgi-
cal wound after her second heart trans-
plant.4
Withtopicaltimolol0.5%,saysDr.
Kirsner,whotreatedher,thewoundepi-
thelialized in about 8 weeks.
More recently, he published a case
series in which three of five diverse
chronic wounds treated with topical
timololhealedcompletely,andafourth
achieveddramaticimprovement.5
“Not
everybody does well. But beta blockers
provide an opportunity to reverse pre-
viously nonhealing wounds.”
Clinically, Dr. Kirsner uses topical
timolol for modest superficial wounds,
toachievenotgranulationbutepitheli-
alization. Since optimal dosing has not
yet been determined, he adds, “We use
itconsistentwiththestandardofcare,”
which ranges from daily to weekly.
SKIN GRAFTING TOOLS
Forskingrafting,theCelluTomeEpider-
mal Harvesting System (Kinetic Con-
cepts Inc./Acelity), commercially avail-
able in the United States and Europe,
allows harvesting of epidermal grafts
without creating donor-site scars. “You
placethislittledevice,withoutanesthe-
sia,onthedonorsite(typicallytheinner
thigh) for 20 to 45 minutes.” Using suc-
tion, the device raises approximately 30
tinymicrodomesofepidermis.Pressinga
levershearsallthegraftsoff,sotheycan
be placed on a wound-dressing sheet.
“Then you transfer those little pieces of
epidermis onto the wound. When you
putthemincultureonpatients’skin,the
keratinocytes migrate out of the micro-
domes” to speed wound healing.6
Specifically, says Dr. Kirsner, the mi-
crografts deliver growth factors to the
wound, resulting in edge advance-
ment. Confocal microscopy moreover
has shown that the grafts indeed “take”
wherethey’replanted,resultingindotsof
newepidermisacrossthewoundsurface,
he says. Because the process also trans-
fers melanocytes, it works for vitiligo as
well.Atthedonorsite,“youcan’teventell
anything was done 2 days later.”
The fact that the CelluTome creates
verylittledonor-siteinflammationalso
makes it helpful in addressing wounds
left by pyoderma gangrenosum, after
appropriatepharmaceuticaltreatment,7
and perhaps in other conditions where
inflammationcontraindicatesconven-
tional skin grafting, he says.
Becausetheprocedurecreatesmin-
imal donor-site disruption and is easy
to perform, Dr. Kirsner has used it in
otherindications,includingsicklecell
ulcers and nonhealing wounds in an
elderly male treated for several squa-
mous cell carcinomas.
Conversely, the Xpansion Micro-
Autografting Kit (SteadMed/Applied
Tissue Technologies) minces harvested
skin to create 0.8 mm x 0.8 mm split-
New wound-healing tools arising
from evolving knowledge of the
wound-healing process include
drugs, debridement techniques,
advanced skin grafting tools and
stem cell delivery strategies.
QUICK READ
WOUND HEALING:
Diverse tools and technique advances from page 1
Day 1
Week 5
Month 9
28-year-old female with sickle cell ulcer
before and after treatment with CelluTome
Epidermal Harvesting System
Photo credit: Michael Kirsner, M.D.

* Head-to-head comparison of Topical Hydrocortisone 1%, Topical Diphenhydramine 2% and TriCalm® in a cowhage-induced itch model. Data on file.
BETTER SCIENCE.
BETTER ITCH RELIEF.
BETTER SCIENCE.
BETTER ITCH RELIEF.
TriCalm® is 5 times more effective at reducing itch than hydrocortisone 1%
and 6 times more effective than diphenhydramine 2%.*
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Reduction of Total Itch Perceived (AUC)

®
thickness skin grafts that can cover an
area 100 times the size of the original
graft. There’s no need to orient the mi-
crografts dermal side down, says Dr.
Kirsner.“Thosecells...flipover,ontheir
own,” boosting the wound’s healing ca-
pability.
Somewhat similarly, he says, using
hair-transplantation techniques pro-
vides better stimulation of wound heal-
ing than traditional pinch biopsy tech-
niques, perhaps because hair follicles
contain factors such as stem cells. Pres-
ently,Dr.Kirsnerandhiscolleaguesare
studying the interface between hair fol-
licles and wound healing. “We believe
thattheysharemanyofthesamemecha-
nisms,andsomeoftheinformationand
hairbiologythatwe’velearnedfromhair
diseases can be applied to wounds.”
To improve the quality of conven-
tional skin grafts, Dr. Kirsner adds,
“pre-wounding” donor-area skin ap-
pears helpful.8
In two patients with
chroniclegulceration,“Wetookpinch
biopsies, creating wounds, but didn’t
harvest the skin. We covered it for 3
days, which turned on the healing
process in the grafts, then transferred
them onto wounds.” Pre-wounded
grafts achieved marked improvement
inulcer-bedgranulationtissue,andin-
creased edge advancement.
DEBRIDEMENT: GO BIG
Although debridement represents the
standard of care for chronic wounds,
Dr. Kirsner says, wound-healing spe-
cialists have long debated how exten-
sivelyoneshoulddebride.Basedonase-
riesof312,774chronicwounds,“Itturns
out,themoreyoudebride,thebetter.”9
Biopsies have shown that debride-
ment removes key factors — includ-
ing c-Myc and nuclear expression of
beta-catenin — that prevent keratino-
cytesfrommigratingoutwardfromthe
edges of chronic wounds.10
“Therefore,youwanttonotonlyde-
bride the base of the wound, but also
the edge,” to reach healthier skin.11
In fact, “If you had a sort of molecu-
lar scalpel, you could debride right to
thatedgeandgettothetissuethat’sca-
pable of healing. So we propose envi-
sioningdebridementalmostlikeMohs
surgery,” wherein one examines suc-
cessive layers of excised tissues not for
cancer,butforc-Mycandbeta-catenin.
DELIVERING STEM CELLS
In chronic wounds such as diabetic ul-
cers, Dr. Kirsner says, the pathway by
whichfactorsreleasedfromthewound
traveltothebonemarrowandstimulate
progenitorcells,causingstemcellstomi-
grate to the wound, is perturbed. How-
ever,headds,casereportsshowthatap-
plyingbonemarrow-derivedstemcells
directlyintoafreshlydebridedwound—
viaspray,injectionordressings—speeds
healing while minimizing scarring.12
Similarly,oneofthefewrandomized,
controlled trials in this area showed
that placing MSCs into 18 diabetic ul-
cers led to statistically significant im-
provement versus placebo.13
As such,
“There’s a lot of potential here, using
stem cells including bone marrow-de-
rived stem cells to speed healing, and
work is ongoing.”
MSCs show particular potential be-
cause they’re both anti-inflammatory
and antifibrotic, Dr. Kirsner says. In
one case report, injecting MSCs into
a severe radiation burn at the time of
surgery significantly improved scar-
ring.14
A more recent study revealed
howMSCsdothis,hesays.Onceplaced
intoawound,heexplains,theyquickly
die, releasing factors that improve
scarring.15
“Work is underway to fig-
ure out exactly what those factors are.
Ifwecanidentifythem,maybewedon’t
even need the MSCs.”
Presently, Dr. Kirsner’s colleagues
are evaluating mechanisms for deliver-
ingMSCs.Inthisregard,hesaysthatla-
ser-created channels appear more effi-
cientthandressings,spraysorinjections,
particularly for burns and war wounds.
SIMPLE SCAR REDUCTION
Forfull-thicknesssurgicalwounds,“The
standardofcareistosutureitclosed.But
often,wesutureitclosed,maybeapplya
dressing,andbelieveourworkisdone.”
Even with optimal surgical technique,
however,countertensionmaywidenthe
scar over time.
To address this problem, Dr. Kirsner
suggested considering Embrace Ad-
vanced Scar Therapy (Neodyne Bio-
sciences), a commercially available
dressing that is applied weekly for up to
eight weeks, starting 1 week after sur-
gery. “It’s a simple tool to reduce post-
surgical skin tension, which results in
better scar formation.” Injecting botu-
linum toxin type A may fulfill the same
function,saysDr.Kirsner.Animalstud-
iessuggestthisstrategyworks,16
“Butthe
human studies are not yet robust.” DT
Disclosure: Dr. Kirsner is an advisor for Acelity.
REFERENCES
1.Marucha PT, Kiecolt-Glaser JK, Favagehi M. Mu-
cosal wound healing is impaired by exami-
nation stress. Psychosom Med. 1998 May-
Jun;60(3):362-5.
2.Léauté-Labrèze C, Dumas de la Roque E, Hubi-
che T, Boralevi F, Thambo JB, Taïeb A. Proprano-
lol for severe hemangiomas of infancy. N Engl J
Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/
NEJMc0708819.
3.Mohammadi AA, Bakhshaeekia A, Alibeigi P,
et al. Efficacy of propranolol in wound heal-
ing for hospitalized burn patients. J Burn Care
Res. 2009 Nov-Dec;30(6):1013-7. doi: 10.1097/
BCR.0b013e3181b48600.
4.Tang JC, Dosal J, Kirsner RS. For topical timo-
lol for a refractory wound. Dermatol Surg. 2012
Jan;38(1):135-8.
WOUND HEALING:
“We create three to six times as many
wounds that we must repair [versus
general surgeons and plastic
surgeons]. So we should know
how to take care of those
wounds.”
Robert S. Kirsner, M.D., Ph.D.
Miami Fla.

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to use ONEXTON
Gel safely and effectively. See full prescribing information for ONEXTON Gel.
ONEXTON™ (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75%, for
topical use
Initial U.S. Approval: 2000
CONTRAINDICATIONS
Hypersensitivity
ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity
to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.
Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported
in postmarketing use with ONEXTON Gel [see Adverse Reactions]
WARNINGS AND PRECAUTIONS
Colitis/Enteritis
Systemic absorption of clindamycin has been demonstrated following topical use of
clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous
colitis) have been reported with the use of topical and systemic clindamycin. If
significant diarrhea occurs, ONEXTON Gel should be discontinued.
Severe colitis has occurred following oral and parenteral administration of
clindamycin with an onset of up to several weeks following cessation of therapy.
Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong
and/or worsen severe colitis. Severe colitis may result in death.
Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated
colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal
cramps and may be associated with the passage of blood and mucus. Stool cultures for
Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
Ultraviolet Light and Environmental Exposure
Minimize sun exposure (including use of tanning beds or sun lamps) following drug
application [see Nonclinical Toxicology].
ADVERSE REACTIONS
The following adverse reaction is described in more detail in the Warnings and
Precautions section of the label:
Colitis [see Warnings and Precautions].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in clinical trials of a drug cannot be directly compared to rates observed in
the clinical trials of another drug and may not reflect the rates observed in clinical practice.
These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON
Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
During the clinical trial, subjects were assessed for local cutaneous signs and
symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions
either were the same as baseline or increased and peaked around week 4 and were
near or improved from baseline levels by week 12. The percentage of subjects that had
symptoms present before treatment (at baseline), during treatment, and the percent
with symptoms present at week 12 are shown in Table 1.
Table 1: Local Skin Reactions - Percent of Subjects with Symptoms Present.
Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243)
*Mod. = Moderate
Postmarketing Experience
Because postmarketing 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.
Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported
in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.
DRUG INTERACTIONS
Erythromycin
Avoid using ONEXTON Gel in combination with topical or oral erythromycin-
containing products due to its clindamycin component. In vitro studies have shown
antagonism between erythromycin and clindamycin. The clinical significance of this in
vitro antagonism is not known.
Concomitant Topical Medications
Concomitant topical acne therapy should be used with caution since a possible
cumulative irritancy effect may occur, especially with the use of peeling, desquamating,
or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application
or temporarily interrupt treatment and resume once the irritation subsides. Treatment
should be discontinued if the irritation persists.
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. ONEXTON Gel should be
used with caution in patients receiving such agents.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women treated with
ONEXTON Gel. ONEXTON Gel should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Animal reproductive/developmental toxicity studies have not been conducted with
ONEXTON Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin
performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120
times amount of clindamycin in the highest recommended adult human dose based
on mg/m2
, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40
times the amount of clindamycin in the highest recommended adult human dose
based on mg/m2
, respectively) revealed no evidence of teratogenicity.
Nursing Mothers
It is not known whether clindamycin is excreted in human milk after topical application
of ONEXTON Gel. However, orally and parenterally administered clindamycin has been
reported to appear in breast milk. Because of the potential for serious adverse reactions
in nursing infants, a decision should be made whether to use ONEXTON Gel while
nursing, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness of ONEXTON Gel in pediatric patients under the age of 12
have not been evaluated.
Geriatric Use
Clinical trials of ONEXTON Gel did not include sufficient numbers of subjects aged 65
and older to determine whether they respond differently from younger subjects.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity and impairment of fertility testing of ONEXTON Gel have
not been performed.
Benzoyl peroxide has been shown to be a tumor promoter and progression agent in
a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg
administered topically twice per week for 20 weeks induced skin tumors in transgenic
Tg.AC mice. The clinical significance of this is unknown.
Carcinogenicity studies have been conducted with a gel formulation containing
1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in
mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day
(1.8, 5.4, and 30 times amount of clindamycin and 2.4, 7.2, and 40 times amount of
benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel
based on mg/m2
, respectively) did not cause any increase in tumors. However, topical
treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl
peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in
the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal
carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment
with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12
times amount of clindamycin and 1.6, 4.8, and 16 times amount of benzoyl peroxide
in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/
m2
, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week
dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by
12 weeks of observation), the median time to onset of skin tumor formation decreased
and the number of tumors per mouse increased relative to controls following chronic
concurrent topical administration of the higher concentration benzoyl peroxide formulation
(5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.
Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome
aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety
of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all
investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.
Fertility studies have not been performed with ONEXTON Gel or benzoyl peroxide,
but fertility and mating ability have been studied with clindamycin. Fertility studies in
rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times
the amount of clindamycin in the highest recommended adult human dose of 2.5 g
ONEXTON Gel, based on mg/m2
) revealed no effects on fertility or mating ability.
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
Distributed by:
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807
Manufactured by:
Contract Pharmaceuticals Limited Mississauga, Ontario, Canada L5N 6L6
U.S. Patents 5,733,886 and 8,288,434
Issued 11/2014
9389300
DM/ONX/14/0031(1)
Before Treatment
(Baseline)
Maximum During
Treatment
End of Treatment
(Week 12)
Mild Mod.* Severe Mild Mod.* Severe Mild Mod.* Severe
Erythema 20 6 0 28 5 <1 15 2 0
Scaling 10 1 0 19 3 0 10 <1 0
Itching 14 3 <1 15 3 0 7 2 0
Burning 5 <1 <1 7 1 <1 3 <1 0
Stinging 5 <1 0 7 0 <1 3 0 <1

CLINICAL DERMATOLOGY
5.Braun LR, Lamel SA, Richmond NA, Kirsner RS.
Topical timolol for recalcitrant wounds. JAMA Der-
matol. 2013 Dec;149(12):1400-2. doi: 10.1001/jama-
dermatol.2013.7135.
6.Osborne SN, Schmidt MA, Derrick KL, Harper JR.
Epidermal micrografts produced via an automated
and minimally invasive tool form at the dermal-epi-
dermal junction and contain proliferative cells that
secrete wound-healing growth factors. Adv Skin
Wound Care. (In press).
7.Richmond NA, Jamel SA, Braun LR, Vivas AC, Ser-
ena T, Kirsner RS. Epidermal grafting using a novel
suction blister harvesting system for the treatment
of pyoderma gangrenosum. JAMA Dermatol. Pub-
lished online August 6, 2014. Accessed February
23, 2015.
8.Kirsner RS, Falanga V, Kerdel FA, Katz MH, Eagl-
stein WH. Skin grafts as pharmacological agents:
pre-wounding of the donor site. Br J Dermatol. 1996
Aug;135(2):292-6.
9.Wilcox JR, Carter MJ, Covington S. Frequency of
debridements and time to heal: a retrospective co-
hort study of 312,744 wounds. JAMA Dermatol.
2013 Sep;149(9):1050-8. doi: 10.1001/jamaderma-
tol.2013.4960.
10. Brem H, Stojadinovic O, Diegelmann RF, et al. Mo-
lecular markers in patients with chronic wounds
to guide surgical debridement. Mol Med. 2007
Jan-Feb;13(1-2):30-9.
11. Tomic-Canic M, Ayello EA, Stojadinovic O, Golinko
MS, Brem H. Using gene transcription patterns
(bar coding scans) to guide wound debride-
ment and healing. Adv Skin Wound Care. 2008
Oct;21(10):487-92; quiz 493-4. doi: 10.1097/01.
ASW.0000323563.59885.1c.
12. Badiavas EV, Falanga V. Treatment of chronic
wounds with bone marrow-derived cells. Arch
Dermatol. 2003 Apr;139(4):510-6.
13. Dash NR, Dash SN, Routray P, Mohapatra S, Mo-
hapatra PC. Targeting nonhealing ulcers of lower
extremity in human through autologous bone
marrow-derived mesenchymal stem cells. Re-
juvenation Res. 2009 Oct;12(5):359-66. doi:
10.1089/rej.2009.0872.
14. Bey E, Prat M, Duhamel P, et al. Emerging ther-
apy for improving wound repair of severe radia-
tion burns using local bone marrow-derived stem
cell administrations. Wound Repair Regen. 2010.
18:50-58. doi: 10.1111/j.1524-475X.2009.00562.x.
15. Liu S, Jiang L, Li H, et al. Mesenchymal Stem
Cells Prevent Hypertrophic Scar Formation via In-
flammatory Regulation when Undergoing Apop-
tosis. J Invest Dermatol. 2014. 134: 2648–2657.
doi:10.1038/jid.2014.169. Published online May
29, 2014.
16. Lee BJ, Jeong JH, Wang SG, Lee JC, Goh EK,
Kim HW. Effect of botulinum toxin type A on
a rat surgical wound model. Clin Exp Otorhi-
nolaryngol. 2009 Mar;2(1):20-7. doi: 10.3342/
ceo.2009.2.1.20. Epub 2009 Mar 26.
WOUND HEALING:
T thinking is that an
effective HSV-2 vaccine must stimulate
thebodytoproduceneutralizingantibod-
ies,particularlyagainsttheviralprotein
glycoprotein D (gD-2) through which
HSV-2 accesses human cells. Research-
ersinthepasthavefocusedon“sub-unit”
herpesvaccinesthatrelyprimarilyongD-2
astheantigentostimulatethebody’san-
tibodyresponse.Noneofthese,however,
haspreventedHSV-2infectioninhumans.
Using a non-traditional approach, a
researchteamattheAlbertEinsteinCol-
lege of Medicine, Bronx, N.Y. — headed
by Betsy Herold, M.D., and William Ja-
cobs Jr., Ph.D. — developed a vaccine
that prevented active and latent infec-
tions caused by herpes simplex virus
type 2 (HSV-2) from occurring in mice
and published their findings.1
AccordingtoDr.Jacobs,professor and
Leo and Julia Forchheimer chair in mi-
crobiologyandimmunologyatEinstein,
the team took an approach that runs
countertowhatmostscientiststake.“We
tookacompletelydifferentapproachand
deleted glycoprotein D from the virus,”
Dr. Herold, vice chair for research at
Einstein, tells Dermatology Times.
“The deleted strain, which is markedly
attenuated and cannot spread, is com-
pletely safe and provided 100% protec-
tionagainstbothHSV-1andHSV-2,and
prevented the establishment of latency
in different mouse models, including a
model of skin infection.”
Whenthevaccine,calleddelta-gD-2,
was given to mice, it provided complete
protection against subsequent infec-
tion with normal HSV-2. No virus was
detected in vaginal or skin tissue of
vaccinated mice or in neural tissue,
where HSV-2 often lays latent. When
unvaccinated mice were challenged
with HSV-2, all showed evidence of the
virus in the three tissue sites, and all
succumbed to the disease. Initial tests
suggest that the vaccine is also effective
against HSV-1, though further evalua-
tion is needed to confirm this.
The new vaccine also appears to
be safe. The researchers calculated
the number of viruses needed to kill
mice, then administered 1,000 times
that number of delta-g D-2 viruses to
mice that lacked immune systems. The
result: The mice survived and didn’t
develop herpes.
“For the first time in history, we have
successfully developed a vaccine that
prevents HSV-1 and HSV-2, using an
approach that experts thought was
doomed to fail,” Dr. Jacobs says. “If this
vaccineprotectshumansasitdoesmice,
herpes could be eradicated.”
TheEinsteinteamplanstobeginclin-
icaltrialsonhumanswithinafewyears.
“We hope that this vaccine can-
didate, which elicits a different type
of immune response than prior vac-
cines, will prove equally protective in
cl i n ica l st ud ies,” Dr. Herold
says. “We are planning to con-
duct t he pre-clin ica l st ud ies
required by the Food and Drug
Administrationtoallowustomovethis
vaccineintoaphase1clinicaltrial.”DT
Disclosures: The Albert Einstein College of Medicine
has filed patent applications related to this research
and is seeking licensing partners able to further de-
velop and commercialize this technology.
REFERENCES:
1.Petro C, González PA, Cheshenko N, et al. Her-
pes simplex type 2 virus deleted in glycoprotein D
protects against vaginal, skin and neural disease.
Elife. 2015;4
Vaccine has potential to prevent
genital herpes
BILL GILLETTE | STAFF CORRESPONDENT

®
COSMETIC DERMATOLOGY22
29LIPO-202
Fat reduction injectable
enters phase 3 trials
N – Although pico-
second lasers have changed the tat-
too-removalgame,oldertechnologies
suchasQ-switchedlasersremainvery
valuable players, experts say.
Nowavailableinthreewavelengths,
picosecond lasers have made some of
the toughest-to-treat tattoo colors the
easiest, says Roy Geronemus, M.D.,
director of the Laser & Skin Surgery
Center of New York and clinical pro-
fessor of dermatology at New York
University Medical Center.
HOME RUN
First on the market was the PicoSure
(Cynosure),whichoperatesatthe755nm
alexandrite wavelength. “Although it
can be used for many colors, the home
runwiththatdevicehasbeenwithblue
Laser tattoo removal:
rethinking ink
JOHN JESITUS | STAFF CORRESPONDENT
There’s a total
epidemic of
people wanting
their tattoos
removed.”
Eric F. Bernstein, M.D.
Ardmore, Penn.
Tattoo removal: a booming
business
See story page 26
New picosecond lasers allow
for faster treatment of several
once-difficult tattoo inks such
as green, blue, red, orange and
yellow. Meanwhile, Q-switched
laser regimens continue to
evolve, sometimes in combination
with fractional ablation.
QUICK READ
Quotable DTExtra
Cosmetic tattoo before and after three treatments with a Q-switched Nd:YAG laser Photos: George Hruza, M.D.
and green ink.” In previously untreated
tattoos,hesays,thislaseroftenremoves
these colors in one to three sessions,
versus10to15ormorewithQ-switched
lasers,whichcouldstillleaveresidualink.
Darker colors and resistant tattoos
alsofarebetterwiththe755nmpicosec-
ondlaserthantheydidwithQ-switched
lasers, he adds. In February 2015, the
FDA cleared a 532 nm Laser Delivery
System that’s available as an add-on to
the PicoSure platform.
With the 532 nm wavelength, yellow
ink—whichpreviouslyprovedverydif-
ficult to remove — disappears in one to
four treatments.1
“We’re seeing good
resultswithredandorangeaswell,”says
Dr. Geronemus.
Picosecond lasers that combine
the 532 nm (KTP) and 1,064 nm
Nd:YAG wavelengths include the
PicoWay (Syneron & Candela) and the
enlighten (Cutera).
Eric F. Bernstein, M.D., M.S.E., who
was first to use the PicoWay laser, says,
“Ifyoucanonlyhaveonelaserfortattoo
removal,it’sgottobeanNd:YAGbecause
epidermal melanin absorbs less energy
atthiswavelengthsoitallowsyoutotreat
all skin types. And Nd:YAG lasers are
great for removing black ink.” Though
less effective than the 755 nm wave-
length for blue and green ink, he adds,
the PicoWay’s 532 nm laser removes
RETHINKING INK see page 56
“The LFS is the only validated scale for lips that
includes actual photographs of lips, rather than
computer-morphed digital images, and also includes
African-American females... The LFS is a clinically
useful, validated and expanded scale designed for
assessing lip fullness across a wide variety of races and
ethnicities and goes beyond those scales previously
designed for clinical trials, or computer-generated
morphs. To date, the LFS is the only published scale
that includes African-Americans with marked to very
marked lip fullness.”
Wm. Philip Werschler, M.D.,
Associate clinical professor of medicine and
dermatology at the University of Washington
SOURCE: HTTP://BIT.LY/LIPFULLNESSSCALE

*Aminoﬁl®,NeoGlucosamine®,andMaltobionicAcidareNeoStrata’spatentedtechnologies;Prodew®isaregisteredtrademarkofAjinomoto.
©2015NeoStrataCompany,Inc.
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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 placebo-
controlled 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 OTEZLA 30 mg BID
Preferred Term (N=506) (N=920)
n (%) 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)
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 OTEZLA 30 mg BID
Preferred Term (N=506) (N=920)
n (%) n (%)
Dyspepsia 6 (1) 29 (3)
Decrease appetite 5 (1) 26 (3)
Insomnia 4 (1) 21 (2)
Back pain 4 (1) 20 (2)
Migraine 5 (1) 19 (2)
Frequent bowel movements 1 (0) 17 (2)
Depression 2 (0) 12 (1)
Bronchitis 2 (0) 12 (1)
Tooth abscess 0 (0) 10 (1)
Folliculitis 0 (0) 9 (1)
Sinus headache 0 (0) 9 (1)
*Two subjects treated with OTEZLA experienced serious adverse reaction of
abdominal pain.
Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) patients
following discontinuation of treatment with OTEZLA (apremilast).
DRUG INTERACTIONS
Strong CYP 450 Inducers: Apremilast exposure is decreased when OTEZLA is
co-administered with strong CYP450 inducers (such as rifampin) and may
result in loss of efficacy [see Warnings and Precautions (5.3) and Clinical
Pharmacology (12.3)].
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy Category C: OTEZLA should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus. Pregnancy
Exposure Registry: There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to OTEZLA during pregnancy.
Information about the registry can be obtained by calling 1-877-311-8972.
Nursing Mothers: It is not known whether OTEZLA or its metabolites are present
in human milk. Because many drugs are present in human milk, caution should
be exercised when OTEZLA is administered to a nursing woman. Pediatric use:
The safety and effectiveness of OTEZLA in pediatric patients less than 18 years
of age have not been established. Geriatric use: Of the 1257 patients who
enrolled in two placebo-controlled psoriasis trials (PSOR 1 and PSOR 2), a total
of 108 psoriasis patients were 65 years of age and older, including 9 patients
who were 75 years of age and older. No overall differences were observed in
the efficacy and safety in elderly patients ≥65 years of age and younger adult
patients <65 years of age in the clinical trials. Renal Impairment: OTEZLA
pharmacokinetics were not characterized in patients with mild (creatinine
clearance of 60-89 mL per minute estimated by the Cockcroft–Gault equation)
or moderate (creatinine clearance of 30-59 mL per minute estimated by the
Cockroft–Gault equation) renal impairment. The dose of OTEZLA should be
reduced to 30 mg once daily in patients with severe renal impairment (creatinine
clearance of less than 30 mL per minute estimated by the Cockroft–Gault
equation) [see Dosage and Administration (2.2) and Clinical Pharmacology
(12.3)]. Hepatic Impairment: Apremilast pharmacokinetics were characterized
in patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic
impairment. No dose adjustment is necessary in these patients.
OVERDOSAGE
In case of overdose, patients should seek immediate medical help. Patients
should be managed by symptomatic and supportive care should there be an
overdose.
Manufactured for: Celgene Corporation, Summit, NJ 07901
OTEZLA® is a registered trademark of Celgene Corporation.
Pat. http://www.celgene.com/therapies
©2014 Celgene Corporation, All Rights Reserved.
Based on APRPI.003 OTZ_PsO_HCP_BSv.003 09_2014
Rx Only

®
26 COSMETIC DERMATOLOGY
surgical neck contouring and lifting
procedure.Theresultsarepermanent,
asthedrugiscytotoxictothefatcells,”
Dr.ToroktellsDermatologyTimes.The
drugisnotapprovedorrecommended
for use outside the submental area.
“When properly injected into sub-
mental fat, the drug destroys fat cells;
however,itcanalsodestroyothertypes
of cells, such as skin cells, if it is inad-
vertently injected into the skin,” ac-
cording to the FDA’s release.
Dermatologists can use up to 50
injections in a treatment and up to
six single treatments given a month
apart. Kybella’s single-patient-use
vials should not be diluted or mixed
with other compounds.
Common side effects associated
with Kybella include swelling, bruis-
ing, pain, numbness, redness and
hard areas where patients have been
treated. Dermatologists should note
that Kybella can cause serious side ef-
fects. One such side effect is nerve in-
juryinthejaw,whichcanresultintrou-
ble swallowing, facial weakness or an
uneven smile.
“The expected side effects of swell-
ing, redness and pain are the result of
the drug having its expected effect on
the cells and this resolves over a pe-
riod of several weeks,” Dr. Torok says.
Dermatologists should use caution in
patients who have had prior surgical
or aesthetic treatment of the submen-
tal area. And if there is no distinctive
hologramontheviallabel,dermatolo-
gists are urged not to use the product.
“Treatment with Kybella should
only be provided by a licensed health
care professional, and patients should
fully understand the risks associated
with use of the drug before consid-
ering treatment,” says Amy G. Egan,
M.D., M.P.H., a deputy director in the
FDA’s Center for Drug Evaluation and
Research. DT
SHRINK DOUBLE CHINS WITHOUT SURGERY
Injectable approved for submental fat from page 1
N –AsAmericans’taste
fortattooshasgrown,expertssay,sohave
many tattoo wearers’ regrets.
Nationally, says Eric F. Bernstein,
M.D.,M.S.E.,“There’satotalepidemicof
people wanting their tattoos removed.”
He is clinical professor, Department of
Dermatology, University of Pennsylva-
nia School of Medicine.
George Hruza, M.D., M.B.A., says he
commonly sees parents who want tat-
toos removed from children — who got
themwithoutpermission—asyoungas
16. He is a Chesterfield, Missouri-based
dermatologist in private practice. Dr.
Bernsteinaddsthathe’sremovedrecent
tattoosfrompatientsfrom14yearsoldto
senior citizens.
Regardingtattoolocations,Dr.Hruza
says that as tattoos have grown more
mainstream,heincreasinglyzapsthem
from highly visible areas such as the
neck,oncethewearersrethinktheirink.
Roy Geronemus, M.D., adds that as
people become more aware that lasers
can safely and effectively remove tat-
toos, he sees growing numbers of pa-
tients with lip and eyeliner tattoos they
wantremoved.HeisdirectoroftheLaser
& Skin Surgery Center of New York and
clinicalprofessorofdermatologyatNew
York University Medical Center.
Treating tattooed-on cosmetics can
betricky,however.Frequently,explains
Dr. Hruza, they contain iron oxide (for
tan and rust tones) or titanium diox-
ide (for pastels and flesh tones). Imme-
diately after Q-switched or picosecond
laser treatment, he says, both materials
oftenirreversiblydarkentograyorpitch-
blacktonesasrefractoryasgenuineblack
ink.Dr.Bernsteinsaysthedarkenedpig-
mentcantakedoubleortripletheusual
Tattoo removal
Tattoo removal is booming,
experts say, even among patients
at extremes of the age spectrum.
However, removing trendy lip-
and eyeliner tattoos can be tricky
because they often contain iron
oxide or titanium dioxide.
QUICK READJOHN JESITUS | STAFF CORRESPONDENT
“Thetattoo-removal
businessisbooming
—andit’sonlygoing
tokeepboomingas
timegoeson.”
Ardmore, Penn.
numberofQ-switchedlasertreatments.
Whenusingsuchlasersforfacialcos-
metic tattoos, particularly with rusty
hues,Dr.Hruzarecommendsfirsttreat-
ing a small test spot — which one can
surgically excise if it darkens. Alterna-
tively, Dr. Geronemus uses an ablative
CO2
or fractional ablative CO2
laser for
tattoos containing iron oxide or tita-
nium dioxide.
Dr. Bernstein says that although he
has not yet treated cosmetic tattoos
with the PicoWay 532/1064 nm pico-
second laser (Syneron & Candela), he
hopes that it simplifies the task. For
now, he says that as tattooed Ameri-
cansgetolderandperhapswiser,“The
tattoo-removalbusinessisbooming—
and it’s only going to keep booming as
time goes on.” DT
Disclosures: Dr. Geronemus is a clinical investigator
for Cynosure, Syneron & Candela and Cutera. Dr. Ber-
nstein is head of Syneron & Candela’s medical advi-
sory board and received a research grant from the
company to perform the PicoWay Phase III trial. Dr.
Hruza reports no relevant financial interests.
A booming business
“There’s a total
epidemic of people
wanting their
tattoos removed.”
Ardmore, Penn.

Introducing
RETIN-A MICRO
®
(tretinoin) Gel microsphere,
Exclusively available in a 50g pump
Except as otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies.
© 2014 Valeant Pharmaceuticals North America LLC. DM/RAM/14/0003 06/14 Printed in USA.
NEW
STRENGTH!

COSMETIC DERMATOLOGY
A approved for use in
asthma inhalers is reported to begin
phase 3 trials during the first half of
2015 for use as an injectable option in
fat reduction and body contouring.
LIPO-202 (Neothetics) is a physician-
administered injectable form of sal-
meterolxinafoate,abeta-2adrenergic
receptor that not only helps asthmat-
ics breathe better but also shrinks fat
cells, according to researchers.
Marina Peredo, M.D., a derma-
tologist in Manhattan and Long
Island, N.Y., and clinical investigator
for LIPO 202, says physicians can per-
form the nonsurgical procedure in
less than 5 minutes. The procedure
includes making 20 injections, about
4 cm apart, at the site of an abdom-
inal fat bulge. Patients come back
weekly, for a total of 8 weeks. Often
by the first month, she says, they
notice a circumference change
in their bodies. It’s painless and
requires no downtime.
“I think this product is going to do
to body contouring or body sculpt-
ing what Botox did to facelifts,” Dr.
Peredo says.
LIPO-202 PHASE 2 RESULTS
Based on the clinical phase 2 stud-
ies, LIPO-202 is effective at reduc-
ing abdominal fat and has a side ef-
fect profile virtually identical to pla-
cebo, says Mark Nestor, M.D., Ph.D., a
clinical investigator in LIPO-202
phase 2 clinical trials and co-chair of
Neothetics’ scientific advisory board.
“Patients in the study appear to
be very satisfied with the results,”
says Dr. Nestor, director for the Cen-
ter for Clinical and Cosmetic Re-
search and the Center for Cosmetic
Enhancement in Aventura, Fla., and
voluntar y associate professor,
dermatology and cutaneous surgery,
University of Miami Miller School of
Medicine, Miami, Fla.
Neothetics, formerly Lithera, an-
nounced results from its phase 2b
RESET clinical study of LIPO-202 in
a September 30, 2013, press release.
Researchers tested three doses (0.4,
1.0 and 4.0 µg) in a multicenter, ran-
domized, placebo-controlled trial,
including 513 healthy, nonobese
people with abdominal bulging due
to excess subcutaneous fat.
Ideal candidates were those
bothered by slight to moderate
abdominal bulges, according to Dr.
Peredo. “If they were too heavy, this
was not an indication, at least for this
particular study,” she says.
An additional exclusion criterion
was use of inhalers because it’s the
same medication, according to Dr.
Peredo.
Researchers found the optimal
treatment dose was 0.4 µg (20 times
0.02 µg/mL). Adverse events with
LIPO-202 were generally mild, tran-
sientandsimilartoplacebo.Themost
common adverse event was injection
site reactions, according to the press
release, and no patients withdrew
from the study for this reason.
Asforefficacy,“Responderanalyses
usingacompositeendpointofapatient
self-assessment(5-pointverbalPatient
Global Abdominal Profile Scale – P-
GAPS)plusaclinicianratingofabdom-
inal contour (6-point visual Clinician
Photo-numeric Scale – CPnS) demon-
stratedsignificantefficacyofLIPO-202
at the 0.4 µg dose versus placebo…,”
according to the release.
Patients in the treatment group
showed a mean reduction in cir-
cumference at the umbilicus of 1.6
cm versus 0.65 cm for placebo. The
average reduction in abdominal vol-
ume in the treatment zone was 192 cc
for the 0.4 µg LIPO-202 dose versus 68
cc for placebo.
SALMETEROL SAFETY PROFILE
The inhaled form of salmeterol, one of
the medicines found in Advair (GSK),
hasalistofsideeffectsrangingfromthe
more common — shortness of breath
and chest tightness — to the more
dangerous, including irregular heart-
beat.Unexplainedweightlossisoneof
the less common side effects.
Dr.Nestorsayssalmeterolxinafoate
is a widely used, very safe medication
forlungdiseaseandhasbeenapproved
for that indication for many years.
“Studies have show n a side
effect profile similar to placebo when
inhaled directly resulting in much
higherbloodlevelsthancanbeachieved
by the amount utilized in clinical
LIPO-202 see page 34
LIPO-202 enters Phase 3 trials
for injectable fat reduction
LISETTE HILTON | STAFF CORRESPONDENT
LIPO-202is
effectiveatreducing
abdominalfatand
hasasideeffect
profilevirtually
identicaltoplacebo.
It’spainless
andrequiresno
downtime.
“I think this product is going to do to
body contouring or body sculpting what
Botox did to facelifts. Injecting this
substance bolsters metabolism.
We’re not killing fat cells; we’re
actually just shrinking them.”
Marina Peredo, M.D.
Long Island, N.Y.

DermatologyTimesJune2015

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