Clinical Analysis for Today’s Skincare Specialists July 2015 | VOL. 36, NO. 07 |

By Ilya Petrou, M.D. | Staff Correspondent

To sell or not to sell...that is the questionLisette Hilton | Staff Correspondent

In This Issue July 2015 VOL. 36, NO. 07

CLINICAL 14

Pediatric trials for AD systemic treatmentsFDA DODAC supportive of pediatric clinical trials

COSMETIC 26

Hair removal lasers: are they right for your practice?Business considerations, safety tips and nuances

ONCOLOGY 30

Personalized melanoma vaccines debut in humansFirst human trial of personalized vaccines

BUSINESS 40

How to start a clinical trial programExperts share the how-to details

| THE TAKEAWAY | KELLY CORDORO, M.D., discusses differentiating diseases and treatment recommendations for pediatric dermatology. SEE PAGE 44

Although NRAS mutations are fre-quently found in congenital melanocytic nevi, new research data has revealed that BRAF mutations are also associated with the development of these nevi as well as with neurocutaneous melanocytosis. According

to one expert in the field, these breakthrough findings could

BRAF gene mutation breakthrough

for targeted therapies

potentially open the door in the future for BRAF-targeted therapies in select congen-ital melanocytic nevi and neurocutaneous melanocytosis cases that test positive for the BRAF mutated gene, offering much needed hope for this patient population.

“Even though dermatologists are some-CONGENITAL MELANOCYTIC NEVI see page 36

Dermatology practices are attracting private equity buyers who have the poten-tial to swoop in and make problems like heavy debt vanish. But there are impor-tant considerations to take into account before signing away full ownership.

David Wagener, M.B.A., C.P.A., pre-sented on the variety of options that phy-sicians have to select from at the AAD 2015 annual meeting in San Francisco. Wagener is CEO of the Miami, Fla., group practice Skin and Cancer Associates, and presi-dent of the practice’s management firm, Advanced Dermatology Management.

INVESTOR-OWNED GROUP PRACTICE

Being part of an investor-owned group practice is among the choices open to practices and is something relatively new to consider, he says.

To accomplish this, private equity firms partner with dermatology and other practices in a transaction that optimizes alignment between the practice and in-vestor, maximizes financial flexibility and positions the newly formed company for

Business

TO SELL OR NOT TO SELL see page 41

A

SHOWN HERE A. Giant Congenital Melanocytic Nevus (GCMN) with extensive nodularity involving the upper back and neck. B. Hairy GCMN involving the entire back. Satellites are evident in the extremities.

Source: Miguel Reyes-Múgica, M.D.

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3JULY 2015 ⁄ DERMATOLOGYTIMES.COM EDITORIAL ADVISORY BOARD

Insight & Opinion From Our Advisory Board Leaders

According to Wikipedia, the dif-

ferential approach to diagno-

sis was first suggested a century

ago by a pioneering German psychia-

trist, Emil Kraeplin, but contributions to

the evolution of the differential diagnosis

(Ddx) have been made by countless out-

standing physician-scientist-educators.

The golden age of U.S. medicine nurtured

the great diagnosticians, including Inter-

nal Medicine’s Tinsley Randolph Harrison,

Pediatrics’ Frank Oski and Dermatolo-

gy’s Samuel Moschella and Walter Shelly.

As a medical student, I sat in awe at Dr.

Ralph Feigin’s “Rounds,” a series of case

presentations with comprehensive Ddx.

Since then, nailing the diagnosis has been

my loftiest goal.

Almost 30 years have passed since I

was inspired by Feigin Rounds. I am now

very familiar with a long (and ever-ex-

panding) list of common and rare con-

ditions that apply to complex patients

in search of a diagnosis, especially be-

cause cutaneous signs are readily availa-

ble clues that require a trained eye, rather

than imaging or laboratory testing. So for

me, compiling the Ddx list is now much

less difficult than communicating the pos-

sibility of a life-altering diagnosis, espe-

cially to an unsuspecting patient, family

and referring physician.

One of my most memorable early

challenges was an infant referred for

“eczema.” When I walked in the room,

his other features took precedence: fail-

ure-to-thrive, sparse, brittle hair and verti-

cal nystagmus. Although I had never seen

a case, trichothiodystrophy was at the

top of my Ddx. However, I was much less

sure about the best way to communicate

my concerns to the baby’s medically un-

sophisticated mother. I started by gently

pointing out his unusual features followed

by a phrase that has served me well since

then: “Has your doctor ever mentioned

this to you?”

A year or so later, a more medically so-

phisticated mother brought her 8-month-

old son in for evaluation of “eczema.” She

was convinced that he had food-allergy

triggered atopic dermatitis, and had

restricted his diet to elemental formula,

so I allowed her opinion to sway my inex-

perienced diagnostic skills. Although my

documented impression was incorrect, I

commented on the atypical distribution of

his erythroderma, accentuated at the skin

folds and diaper area. I did not see him

again until almost age 3, when his obvi-

ously brittle hair moved Netherton’s to the

top of the list. A little later, his similarly

affected sister was born.

In the past 2 decades, I have diag-

nosed hundreds of children with uncom-

mon and rare disorders. In many cases,

medical advances have defined stand-

ard evaluation, and even successful treat-

ment: confirmatory gene testing and IL1

receptor antagonists for the cryopyrin-

opathies; MRA/MRV and propranolol for

PHACE; gene sequencing panels for

infants with epidermolysis bullosa or

collodion phenotype, and the miraculous

clinical trial evaluating the impact of neo-

natal protein replacement on the early

development of teeth, sweat glands and

hair follicles in children affected by X-

linked hypohidrotic ectodermal dysplasia.

But more often, establishing a rare diag-

nosis prompts more angst than action.

Furthermore, the value of nailing a di-

agnosis has gradually diminished, espe-

cially relative to the revenue generated by

procedures or patient volume. But diag-

nosis remains my passion and, occasion-

ally, an annoying obsession. Sometimes, I

can’t help but assess friends, distant

relatives and acquaintances, then agonize

about whether to divulge my suspicions.

In a moment of irony, my brother (who has

a touch of oppositional defiant disorder)

diagnosed me with another ODD (obses-

sive diagnosing disorder).

One day last week, my first patient

was a 15 year old with a chief complaint

of acne. The first glimpse prepared me

for a longer-than-expected visit. He was

Nailing the diagnosistall and thin, with arachnodactlyly. On closer

exam, he had pectus excavatum, a high

arched palate, crowded teeth, hyperextensi-

ble joints, flat feet, prominent striae and mild

acne. His family history was non-contribu-

tory. The reply to my question about his doc-

tor’s mention of the distinguishing features

was that a genetics consultation years earlier

did not recommend any additional evaluation.

This left me with three no-win choices: rec-

ommend a second opinion, ignore the signs

or explain both options in more detail. I chose

the last and most time-consuming (at the

expense of my patients waiting to be seen).

I face a similar conundrum every time I see

an infant with a low-risk midline sacral birth-

mark or a congenital nevus at with low-likeli-

hood of neurocutaneous melanosis: how to

decide on the relative risk-to-benefit of high-

cost imaging requiring general anesthesia?

Sometimes my tendency to minimize expen-

sive evaluation has failed patients. Just last

year, my negative history and physical exam

did not prompt further evaluation for a patient

who presented with erythema nodosum (EN),

and developed hematochezia a year later. I

learned about the IBD via a smug electronic

message from the pediatric gastroenterolo-

gist who performed the colonoscopy. Rather

than sending a defensive eReply, I called her

to discuss the case. She was unaware of

the possibility of “idiopathic” EN, or the wide

range of possible associated extracutaneous

problems.

Investing the time in direct communica-

tion with colleagues, rather than waging chart

wars, is usually a very worthwhile win-win-

win for me, patients and colleagues. It took

me years to recognize the importance of

these informal discussions in fostering

valuable collaboration, and expanding my

own Ddx. These days, when I receive a

request for a biopsy alone, rather than a

diagnostic evaluation, or a limited impression

like “not a surgical candidate,” I make every

effort to contact the clinician for more valua-

ble information hidden in the sound bite.

In the age of EMR, the value of direct com-

munication should be part of medical school

curriculum. Perhaps the ghosts of golden-

age medicine and the current champions of

accountable care and cost-effective medi-

cine will make it so. DT

Elaine C. Siegfried, M.D.,

is professor of pediatrics

and dermatology,

Saint Louis University Health

Sciences Center, St. Louis, Mo.

®

JULY 2015 ⁄ DERMATOLOGYTIMES.COM

4 EDITORIAL ADVISORY BOARD

Let your voice be heard, contact us: editor@dermatologytimes.com

Dermatology Times is the only clinical news resource serving

a readership of more than 14,000 dermatologists and other

professionals focused on skincare. Through unbiased

reporting, we strive to help practitioners put into perspective

developments that affect their business. Our goal is to provide

practical information that will help them to better understand

clinical, regulatory and financial issues, as well

as chart business growth.

Our Mission

PRINTED IN

U.S.A.

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.

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.

Dr. Tina

Alster

Washington D. 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.

Dr. Joel

Schlessinger

Omaha, Neb.

Dr. James

Spencer

St. Petersburg, Fla.

Dr. Helen

Torok

Medina, Ohio

Dr. Philip

Werschler

Spokane, Wash.

Dr. Albert

Yan

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What’s the new FDA Concern with safety of cosmetics?

What’s your diagnosis?

Blog

A 53-year-old woman is

complaining of this somewhat

tender rash on her legs and

feet that has been present

for many months now.

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LAST MONTH’S DIAGNOSIS:

Hidradenitis suppurativa

bit.ly/junediagnosisLearn more at:

MULTIMEDIA

Eradicating actinic keratosis: Pros and Cons

Dr. Neal Bhatia shares his perspective on actinic

keratosis from his Controversies session at the

23rd World Congress for Dermatology: pros and

cons on routine eradication, trending populations

and modalities of treatment. Learn more:

bit.ly/actinickeratosisprosandcons

Laser devices I would buy today vs. throw away

When it comes to

laser devices, what

devices would you buy today and what would

you throw away? Vegas Cosmetic Surgery

2014 Laser Roundtable.

bit.ly/devicesIwouldbuyvsthrowaway

JULY 2015 ⁄ DERMATOLOGYTIMES.COM

6 INTER CTIVEResource Centers

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Best practices in the evaluation and management of actinic keratoses

DermatologyTimes.com/actinickeratoses

Current and emerging therapies for psoriatic arthritis

DermatologyTimes.com/psoriatic-arthritis

Fillers and toxins:Cosmetic and therapeutic options

DermatologyTimes.com/injectables

Insights into managing atopic dermatitis and acne

DermatologyTimes.com/atopicdermatitis

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JULY 2015 ⁄ DERMATOLOGYTIMES.COM

8 LEGAL EAGLE

Dr. Skin has a large dermatology

practice with an emphasis on

acne. Many of his fellow derma-

tologists refer to him their most diffi-

cult patients. In fact, Dr. Skin prides

himself on his ability to manage these

difficult acne patients. For 20 years,

he has been a strong advocate of

using oral retinoids for treatment-

resistant cystic acne and has suc-

cessfully treated many patients.

As would be expected, many pa-

tients have had some side effects; all

have been manageable. He has seen

dose-related headaches, arthralgias,

dry skin and eye, as well as occa-

sional nausea and vomiting in some

patients. In addition, because of the

rare reports of mood changes from

oral retinoids, he asks all patients

about a psychiatric history.

All of his patients have done well

until one (a married highly success-

ful businessman with three children),

who had virtually no prior difficulty

with other acne treatments, shot him-

self in the head 2 years ago. Although

Dr. Skin is saddened by his patient’s

death, he assumes this was a rare

tragedy that was unrelated to the pa-

tient’s treatment.

Soon thereafter, the deceased pa-

tient’s family brings a lawsuit against

Dr. Skin, alleging he was negligent in

prescribing oral retinoids and that the

medication led to the suicide. Worse

than that, the family files a wrong-

ful death lawsuit against Dr. Skin.  Dr.

Skin, of course, is beyond horrified

and hires an attorney to defend him-

self.

After extensive discussions, the at-

torney and defendant physician seek

to have the case thrown out of court.

However, during the mandatory law-

suit required discovery period, it is de-

termined that other patients given oral

retinoids have also committed suicide.

Based on this information, the judge in

the case denies Dr. Skin’s motion for

summary judgment to have the case

thrown out of court. With this informa-

tion, plaintiff’s attorney seeks to settle

the case with Dr. Skin for $6 million.

Dr. Skin becomes very depressed.

His career, practice, reputation and

everything he holds dear are at risk

simply because he tried to be a good

doctor. Should he try to defend him-

self? Will he lose the case at trial?

FOUR ELEMENTS MUST BE PROVED

A medical malpractice case, based on

negligence, can only be won by plain-

tiff’s attorney if four elements can be

proved in a court of law. These ele-

ments are

➧ Duty

➧ Breach of duty

➧ Causation

➧ Damages

A physician is required to perform

his duty as would any reasonable phy-

sician. If he does not do so, he has

breached that duty. Then, if there is

a nexus between the breach of that

duty and damages, the plaintiff may

win her lawsuit. Clearly, the death of

Dr. Skin’s patient has the requisite ele-

ment of damages. Those damages are

measured by the economic value that

would be present if the deceased was

still alive. However, did Dr. Skin per-

form in accordance with a reasonable

duty and, if not, did the breach of that

duty lead to his patient’s death?

If Dr. Skin had prescribed oral reti-

noids and not asked about a history of

depression, then one might argue he

had breached his duty. This, however,

assumes there is scientific evidence

that oral retinoids actually do lead to

an increased incidence of suicide by

patients taking the medication.

Dr. Skin did ask his patient about a

psychiatric history. Although the judge

may not have granted Dr. Skin’s motion

for summary judgement, the plaintiff’s

attorney will need to prove that oral ret-

inoid patients have a higher incidence

of suicide. This will be problematic for

the plaintiff’s attorney. Dr. Skin may

have to defend the lawsuit, but is un-

likely to lose the case. DT

David J. Goldberg, M.D., J.D.

is director of Skin Laser and Surgery

Specialists of New York and New

Jersey; director of laser research, Mount

Sinai School of Medicine; and adjunct

professor of law, Fordham Law School.

My patient with acne committed suicide

His career, practice, reputation and everything he holds dear are at risk simply because he tried to be a good doctor. Should he try to defend himself? Will he lose the case at trial?

Did Dr. Skin perform in accordance with a reasonable duty and, if not, did the breach of that duty lead to his patient’s death?

AM I LIABLE FOR WRONGFUL DEATH?

Finacea® Foam will be in the picture

(azelaic acid) Foam,15%

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JULY 2015 ⁄ DERMATOLOGYTIMES.COM

10 IRREGULAR BORDER

Probiotics, which are helpful bacteria

that protect the body from harm-

ful bacteria, are literally everywhere.

Strolling through the aisles of any grocery

store, we can find yogurts, milks, juices

and other consumables that contain nat-

urally occurring probiotics such as lacto-

bacillus or bifidobacterium, or foodstuffs

that are artificially teeming with these cel-

ebrated organisms. Upon further prob-

ing we even encounter “prebiotics,” or

nondigestible food ingredients (such as

cellulose) that promote the growth of ben-

eficial microorganisms in the intestines —

i.e., sustenance for our symbionts.

In light of increasing antibiotic resis-

tance due to over- and misuse, coupled

with patients’ preferences for more ho-

listic, natural approaches to healing, are

we entering an era of anti-antibiotics and

pro-probiotics? Replacing the drugs with

the bugs, if you will? There is, in fact, in-

teresting literature on the various applica-

tions of probiotics in skin health, and for

integrative practitioners striving to com-

bine the best of allopathy with nature’s

bounty, several of these studies are here

mentioned.

ACNE

In 2014, Bowe et al. reviewed a theory

from 1930 known as the “gut-brain-skin

axis” — essentially, the idea that dis-

turbed emotional states such as stress,

anxiety and depression can reciprocally

contribute to altered gut flora (SIBO: small

intestinal bacterial overgrowth) and GI

leakage, which in turn recruits a systemic

inflammatory response with skin manifes-

tations such as acne.1 While this theory

has not been directly studied with respect

to acne, Parodi and colleagues showed in

2008 that patients with rosacea had a 10-

fold greater incidence of SIBO as com-

pared to healthy controls.2 Additionally,

studies examining the therapeutic bene-

fit of oral and topical probiotic administra-

tion in mild acne patients within the last

decade have been promising, with mech-

anistic theories including decreased re-

lease of inflammatory mediators as well

as increased production of ceramide and

skin barrier restoration.3,4

ATOPIC DERMATITIS

Stapholococcus colonization of skin com-

promised by eczema is a common and

known phenomenon, as is the inflamma-

tory basis of atopic dermatitis. As such,

probiotics theoretically confer a dual ben-

efit of antimicrobial as well as anti-inflam-

matory therapy. In practice, however, the

data is mixed. Initial studies of different

strains of oral lactobacillus for both pre-

vention and treatment of atopic dermatitis

were encouraging,5,6 but follow-up re-

views and meta-analyses have been con-

flicting.7,8,9 Another difficulty in reviewing

the literature is the lack of standardization

in which probiotic strains are tested, in

what dosages, and administered to which

study subject (pregnant/lactating mother

vs. affected child). Overall, the risk of oral

probiotic supplementation appears to be

low (except for a theoretical risk of infec-

tion in immunocompromised patients), so

until more convincing evidence emerges

in either direction, use may be encour-

aged in the interested patient. And, of

further significance, topical probiotics are

another emerging approach to atopic der-

matitis and barrier repair, with the addi-

tional benefit of increasing local ceramide

production.4,10,11

WOUND HEALING / MRSA

Although slightly tongue-in-cheek, the

word “kefir” in the title of this article has a

legitimate place in the wound-healing lit-

erature. Kefirs are natural probiotic com-

pounds (yeast/bacteria fermentation

starters) with anti-inflammatory and anti-

microbial properties, which are typically

packaged into drinkable yogurts and la-

beled as such. Huseini and colleagues re-

searched the application of kefir-based

gels of varying durations of incubation/

potency on mice with cutaneous burns.

The kefir gels were compared to no inter-

vention, gel vehicle alone or silver sulfadi-

azine (conventional therapy). Overall, the

kefir gel with 96 hours of incubation (lon-

gest) yielded superior results in terms of

inflammation, scar formation and wound

re-epithelialization.12 As a purported

mechanism in wound healing, Wong and

colleagues suggested that probiotics may

help to normalize disruptions in human

microbial communities and bacteria-host

interactions that contribute to non-heal-

ing wounds.13

As patients with chronic wounds can

become colonized with MRSA (methicil-

lin-resistant staphylococcus aureus), re-

searchers have also studied what, if any,

role probiotics may play in preventing or

treating MRSA infections. Shu’s group in

2013 found that supplementing mice with

a skin-commensal bacterium (P.Acnes)

resulted in both in vitro / vivo growth sup-

pression of the most prevalent strain of

community-acquired MRSA.14 Another

study looking at species-specific inhibition

of various probiotics and MRSA found in-

hibitory activity of lactobacillus plantarum

both in cell culture and mouse models.15

Dr. Reena Rupani, M.D., FAAD,

Center for Health and Healing

Mount Sinai Beth Israel

Probiotics for healthy skinA SIDE OF KEFIR WITH YOUR KOMBUCHA?

Probiotics, which are helpful bacteria that protect the body from harmful bateria, are literally everywhere.

PROBIOTICS: see page 18

www.CeraVe.com

*Data derived from a bio-instrumental study conducted in 15 female subjects using corneometry. Study was shown to

increase moisture content. Measured against Dove® Sensitive Skin Unscented Beauty Bar and Cetaphil® Daily Cleansing Bar.

CeraVe is a registered trademark of Valeant Pharmaceuticals International, Inc., or its affi liates.MVE is a registered trademark of DFB Technology, Ltd. Patent No. 6,709,663.All other trademarks are the property of their respective owners.Valeant Consumer Products, a division of Valeant Pharmaceuticals North America.©2015 Valeant Pharmaceuticals North America SK/CVE/15/0016 04/15

REFERENCE: 1. Data on fi le. Valeant Consumer Products. Moisturization study. May 2014.

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JULY 2015 ⁄ DERMATOLOGYTIMES.COM

12 VIGNETTEDERMATOLOGY

But only those close to the dermatolo-

gist knew the depths of his despair.

Patients and colleagues remember him

for his love of people, cosmetic derma-

tology, art, culture and song. They also

remember him as always striving to be

at the cutting edge of his field.

THE DERMATOLOGIST

Roy Geronemus, M.D., a member of

the Dermatology Times Editorial Advi-

sory Board, worked with Dr. Brandt at

their New York City practice for two de-

cades and knew him since 1978, when Dr.

Brandt was a dermatology resident at the

University of Miami School of Medicine,

Miami, Fla.

Dr. Geronemus, who gave a eulogy in

honor of Dr. Brandt in New York, says the

two were as different as two people can

be, but they had a mutual respect and

strong friendship. He said that his col-

league was a creative genius in address-

ing the aging face and was distinguished

as the world’s biggest user of Botox and

fillers.

“He made cosmetic dermatology more

scientific,” Dr. Geronemus says. “He put

a lot of thought and creativity into apply-

ing the science of cosmetic dermatology

to the actual implementation. So, he

understood what he was using. He under-

stood anatomy. He understood how the

injectables would work, appropriately, in

such a way that provided a different way

of looking at things. Other dermatologists

wanted to know his secrets and he freely

shared them — he published widely and

lectured all over the world. But very few, if

any, had Fred’s artistic eye.”

Dr. Brandt’s partner in practice in

Coral Gables and former mentee, derma-

tologist Jeremy B. Green, M.D., says Dr.

Brandt would host journal clubs for their

group, including his other partner Joely

Kaufman, M.D.

“Here’s somebody who is 65 years old

and arguably one of the top dermatolo-

gists for what he did on the planet, striv-

ing to learn more, to get better,” says Dr.

Green. “He was a master, who acted like

he was an apprentice.”

Despite his celebrity, following and

reputation, Dr. Brandt was a man of great

humility, according to Dr. Green.

“When I first started working with him,

he’d introduce me as his colleague — his

partner. He treated me as an equal,” says

Dr. Green, noting that “he was always

in the company of famous dermatolo-

gists, plastic surgeons and heads of in-

dustry. He’d introduce me to all these top

people. And that was so amazing. I didn’t

think I deserved that. That’s the person

he was.”

Patients loved him and that love was

mutual, according to his colleagues.

Vanity Fair1 covered the service at the

Alice Tully Hall at Lincoln Center, where

the stage was adorned with 3,000

orchids. (There was a second funeral for

Dr. Brandt in Miami.) Among the celebri-

ties giving eulogies were television per-

sonalities Joy Behar and Kelly Ripa, who

recalled the time Dr. Brandt rapped, “Oh,

Juvéderm, girl, you’re so firm!”

Bursting into song was something Dr.

Brandt did often. He’d sing to patients

and, sometimes, they’d sing along. He

loved Sinatra and the songs from Car-

ousel. One of his favorites to serenade to

patients, a take-off on Duke Ellington’s

doo-wop classic “It won’t mean a thing

if you don’t get a lift,” according to Dr.

Geronemus.

A fun and caring man, Dr. Brandt could

Fredric S. Brandt, M.D.one of cosmetic dermatology’s most celebrated,

accomplished and recognized physicians, died April 5, 2015.

His colleagues, still reeling from the loss, remember

the legacy and brilliance of the man who came

to be known as “The Baron of Botox.”

Farewell to Fredric S. Brandt, M.D.

remember minute details about each of

his patients’ lives.

“People would wait for hours to see

him,” Dr. Green says. “Even though this

was not ideal to some in the waiting room,

once they left, they were beaming. Ironi-

cally enough — for how everything turned

out — Dr. Brandt was a counselor. He

was so much more than a doctor to [his

patients]. He enjoyed the limelight but,

ultimately, what he cared about were the

patients and making sure we did every-

thing safely. Everything had to be on the

cutting edge.”

THE MAN; THE FRIEND

Dr. Geronemus says his partner was really

out there. “He would not wear lab coats

to the office. He would wear designer

clothes. About a month ago, we were

leaving the office together. I was wearing

a Zegna suit, carrying an old fashioned

Wall Street briefcase. Fred was wearing

his typical doctor’s garb — a designer

outfit with a Givenchy bag draped over

his shoulder. We looked at each other and

laughed,” Dr. Geronemus says.

His antics often drew laughs, even in

more serious and professional situations.

“We were in Sweden together helping to

launch the filler Restylane, and he broke

into a rap song about me that he con-

cocted on the spot. It was creative and

hysterical,” Dr. Geronemus says. “He even

got me into the act on occasion including

one holiday party, where we dressed up

as Sonny and Cher — wigs and all. I was

Sonny; he was Cher. We sang ‘I Got You

Babe.’”

Inside, he was the kind of man one

wouldn’t expect, given the façade. The

friendships Dr. Brandt made in and out of

dermatology weren’t about the celebrity,

according to Dr. Green.

“It was about him being a human

being. The clothes he wore and his ap-

pearance — that façade would melt away

Lisette Hilton | STAFF CORRESPONDENT

Fredric S. Brandt, M.D. was 65. He had successful practices in Coral Gables, Fla. and New York City. He branded a lucrative skincare line and cared for A-list clientele. He also suffered from what friends say

was a long battle with depression.

FREDERIC S. BRANDT see page 25

®

JULY 2015 ⁄ DERMATOLOGYTIMES.COMCLINICAL DERMATOLOGY14

24 SCLERODERMA SKIN ULCERS

Tips for managing this challenging condition

The expanding pipeline of drugs for the treatment of atopic dermatitis (AD) is cre-ating excitement among dermatologists as they anticipate effective new therapies akin to the recent breakthroughs that have occurred for management of moderate-to-severe plaque psoriasis. At the same time, however, pediatric dermatology ex-perts have been concerned about the ex-clusion of children from the drug devel-opment process.

Now, after a recent meeting of the Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC), there is good reason to believe that the unmet medical need will be addressed regard-ing systemic treatments approved spe-cifically for children with severe AD.

Elaine C. Siegfried, M.D., Dermatol-

ogy Times editorial advisor and pro-fessor of pediatrics and dermatol-ogy, Saint Louis University Health Sci-ences Center, St. Louis, Mo., served as a

temporary DODAC member for the March 2015 meeting.  She tells Derma-

tology Times, “Prior to the meeting, we anticipated differing opinions about the importance of including children in clinical trials. But at the end of the day there was unanimous agreement that benefits of including children out-weighed the risks, and that even young children should be considered eligible to participate in trials.”

Dr. Siegfried also paid tribute to cur-rent leaders at the FDA whose enlight-ened thinking and collaborative spirit are paving the way to a better future for children with severe skin disease.

She says, “I can’t over emphasize how thrilled the pediatric dermatology com-munity is to have leaders at the FDA like Dr. Kendall Marcus (Director, Division of Dermatology and Dental Products, DDDP) and Dr. Jill Lindstrom (Clinical Team Leader, DDDP) who recognize that children with skin disease have been ther-apeutic orphans and who are interested in moving forward to correct that omission.”

Predicting infection risk could

lead to more targeted treatment

and prevention, as well as reduce

unnecessary antibiotic use. A study led

by Harvard Medical School researchers

looks at 113 burn patients with burns

on more than 20% of their bodies. They

found that a biomarker model based on

observed differences in gene expression

correctly predicted infection susceptibility

of more than 80% of patients.

SOURCE: BIT.LY/PREDICTINGINFECTIONRISK

PEDIATRIC AD see page 17

Pediatric trials for AD systemic treatmentsCHERYL GUTTMAN KRADER

STAFF CORRESPONDENT

Raynaud’s phenomenon is usually present ... Th at phenomenon may create digital ulcers that are horrible in terms of the impact on quality of life of patients.”

Alain Brassard, M.D., FRCPC

Canadian Association of Wound Care

Scleroderma skin ulcersSee story page 24

Quotable DTExtra

Dr. Siegfried observes that, histori-cally, the FDA has always served as a strong guardian of children’s safety. More recently, however, there has been a sea-change in concepts about how best to carry out that responsibility.

She notes that a presentation at the DODAC meeting by Michelle Roth-Cline, M.D., Ph.D., Pediatric Ethicist in the FDA Office of Pediatric Therapeutics, included a slide that eloquently summa-rized the issue, stating, “We have evolved from a view that we must protect chil-dren from research to a view that we must protect children through research.”

Dr. Siegfried adds, “There has also been a misperception that many par-ents would not consent on behalf of their children to participate in trials of investi-gational agents because they don’t want them to be guinea pigs. However, with-out the quality of data on the safety and efficacy of medications possible only through prospective, multicenter clin-ical trials, all children treated off-label are guinea pigs.”

A PRODUCTIVE AFTERNOON

The open session DODAC meeting was sponsored by the DDDP. It featured sev-eral formal presentations delivered by FDA officials and industry representatives, as well as testimony from dermatologists,

PRESCRIBE A TOUGH

TOPICAL

SOOLANTRA® (ivermectin) CREAM, 1%—POWERFULAND RAPID RESULTS FROM A ONCE-DAILY TOPICAL1,2*†

. –20.5 (–64.9%) mean infl ammatory lesion count reduction at week 122*†

. Better effi cacy from once-daily Soolantra Cream, 1% vs twice-daily metronidazole 0.75% cream as early as 3 weeks3‡

. Specifi cally formulated for patients with infl ammatory lesions of rosacea—Cetaphil® Moisturizing Cream was the basis for the vehicle2

www.soolantra.com/hcp

Important Safety Information

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of infl ammatory lesions of rosacea. Adverse Events: In clinical trials with SOOLANTRA® Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation. Warnings/Precautions: Not for oral, ophthalmic, or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see brief summary of Prescribing Information on adjacent page.

* The effi cacy and safety of SOOLANTRA® Cream, 1% once daily was evaluated in subjects aged ≥18 years in 2 identically designed phase 3 clinical trials (N=1371). Final results were comparable between the2 studies, with the least favorable results presented here.

† A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the effi cacy and safety of SOOLANTRA® Cream, 1% once daily in 683 subjects with moderate tosevere papulopustular rosacea (Investigator Global Assessment [IGA] score of 3 or 4).

‡ An investigator-blinded, multicenter, randomized, parallel-group study comparing the effi cacy and safety of SOOLANTRA® Cream, 1% once daily with metronidazole 0.75% cream twice daily in 962 subjects withmoderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.

TREATING INFLAMMATORY LESIONS OF ROSACEA CAN BE TOUGH…

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. 2015;172(4):1103-1110.

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 SOL-255 Printed in USA 06/15

BRIEF SUMMARYThis 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:

>���,%9)�%1<�27,)5�0)(-'%/�'21(-7-216�

>��%5)�35)+1%17�25�3/%11-1+�72�&)'20)�35)+1%17���7�-6�127�.12:1�-*��SOOLANTRA Cream can harm an unborn baby.

>���%5)�&5)%67*))(-1+�25�3/%1�72�&5)%67*))(���7�-6�127�.12:1�-*��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?>��� �����!����5)%0�-6�*25�86)�21�7,)�*%')�21/<�%1(�6,28/(�127�&)�86)(�-1�

the eyes, mouth, or vagina.

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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.

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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.

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about SOOLANTRA Cream. For full Prescribing Information and Patient Information please see the package insert.

>���2�72�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%

17JULY 2015 ⁄ DERMATOLOGYTIMES.COM CLINICAL DERMATOLOGY

researchers with expertise in basic sci-ence, representatives from the National Eczema Association, parents and pedi-atric patients suffering with severe AD, and a series of discussions designed to address various issues relating to the conduct of future clinical trials of novel systemic products for children with AD that is inadequately responsive to topi-cal therapy. Questions explored during the discussions include:➧ How much evidence of treatment ef-

fect and safety should be obtained in adults prior to conducting studies in children?

➧ How much uncertainty about the po-tential risks and benefits is tolerable when initiating a pediatric trial?

➧ What are the features of the appro-priate pediatric population in whom to study systemic treatments so that risks and potential benefits of inves-tigational agents can be compared to the population receiving currently available alternate treatments?

➧ Should older pediatric subpopula-tions be studied prior to or concur-rently with younger pediatric sub-populations?

Lawrence Eichenfield, M.D., chief of Pediatric and Adolescent Dermatology, Rady Children’s Hospital, San Diego, Calif., spoke as a representative for Re-generon-Sanofi, but prior to the meeting he also obtained unanimous support for including children in AD clinical drug trials from non-industry stakeholders. Those groups included the American Academy of Dermatology (AAD), Soci-ety for Pediatric Dermatology, the Inter-national Society of Atopic Dermatitis and the National Eczema Association.

Heartfelt testimony from young pa-tients with severe AD was particularly compelling in bringing forth the impact of the disease on affected children and their families.

“Considering 15 skin conditions using disability-adjusted life years to measure burden, the 2010 Global Burden of Dis-ease Study found ‘dermatitis including eczema’ ranked number one. Yet, until recently, there has been relatively little interest in drug development for this common, often debilitating disease,” says Dr. Siegfried.

“Although interest is growing, the fact remains that AD affects many more

children than adults. With that in mind, pediatric dermatologists have been con-cerned about exclusion of children from investigational research of new drugs that have the potential to better control their disease. We have been struggling for generations to make the best treat-ment recommendations for children with severe AD.  Finally, we have hope for the chance to offer them better op-tions in the foreseeable future.”

THE PATH FORWARD

Seven years ago, as chairman of the En-vironment and Drugs Committee of the AAD, Dr. Siegfried began to explore mech-anisms to facilitate inclusion of children in the new drug development process. At that time, she became aware of the FDA Code of Federal Regulations on Good Guidance Practices1 (GGPs), including the FDA’s policies and procedures for de-veloping, issuing and using guidance doc-uments. Article 10.115 of the Federal Reg-ister2 defines a guidance document as a tool “prepared for FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue. Guidance documents in-clude, but are not limited to, documents that relate to: the design, production, la-beling, promotion, manufacturing, and testing of regulated products...”

Dr. Siegfried initiated her efforts in the early days of new drug development for psoriasis, after recognizing a general reluctance to include children in trials, as well as suboptimal design and lack of standardization among the few studies that were enrolling children. 

“Over the years, we have implemented several action items to further the proc-ess of developing a guidance document that could be adopted by the FDA and used by industry as a framework for pediatric drug trial planning. The re-

cent DODAC meeting has been the most positive step towards acknowledging our efforts, and we are looking forward to working together for the benefit of chil-dren with severe AD.”

With funding and administrative support from the National Eczema Association and the Pediatric Derma-tology Research Alliance, and encour-agement from the FDA, Dr. Siegfried and colleagues are hoping to organ-ize a group of individuals with wide-ranging expertise in clinical trial de-sign relevant to investigation of med-ications for AD in children. Although it may be ambitious, she hopes a draft that can be submitted to the FDA for review and that revision will be com-pleted within a year.

“The FDA has final say on the con-tent of its guidance documents, so FDA review and acceptance are required,” says Dr. Siegfried. “However, we are very pleased that the FDA DDDP leadership is receptive to extramural input. Work-ing together in a positive and coopera-tive way will ultimately lead to develop-ment of the best products.”

In the meantime, Dr. Siegfried ex-pects there will be an ongoing dialogue about the issues of pediatric AD drug de-velopment and that companies involved in this area of research will be approach-ing pediatric study plans with increased interest and effort. DT

Disclosures: Dr. Siegfried serves as a consultant for

Valeant, Promius, Pierre-Fabre, Boeringer-Ingel-

heim and Celgene, and as a principle investigator for

Pierre-Fabre, Anacor and Amgen.

References:

1. http://www.accessdata.fda.gov/scripts/cdrh/

cfdocs/cfcfr/CFRSearch.cfm?fr=10.115 draft

2. http://www.gpo.gov/fdsys/pkg/FR-2000-09-19/

pdf/00-23887.pdf

PEDIATRIC AD:DODAC supportive of clinical trials from page 14

“We have evolved from a view that we must protect children from research to a view that we must protect children through research.”Elaine C. Siegfried, M.D.St. Louise, Mo.

AGING SKIN

Probiotics may also protect the skin

against photoaging. A recent study ex-

amined the impact of orally supple-

menting mice with a bifidobacterium

strain prior to UVB radiation, three times

weekly for 7 weeks. Compared to con-

trols, supplementation significantly sup-

pressed changes in transepidermal

water loss, skin hydration, epidermal

thickening and attenuated the damage

to the tight junction structure and base-

ment membrane induced by chronic

UVB irradiation, possibly via measur-

ably-decreased interleukin-1-beta pro-

duction in the skin.16 This study con-

firmed prior research from 2014, where

mouse supplementation with a bifi-

dobacterium strain attenuated UV-in-

duced barrier perturbation and oxidative

stress of the skin,17 possibly via reduced

generation of reactive oxygen species

(ROS).

GLOW OF HEALTH

As the old adage goes, “You are what

you eat.” So can consuming probiot-

ics induce a “glow of health,” or even a

fountain of youth? Levkovich’s study in

aged mice demonstrated an epithelial

follicular anagen-phase shift with sebo-

cytogenesis, resulting in thick lustrous

fur — all from eating probiotic-supple-

mented yogurt.18 Vegan needs are cov-

ered by kimchi, a fermented Korean cru-

ciferous dish with naturally-occuring

lactobacillus species.19 The fermented

tea beverage known as kombucha con-

fers four main properties: detoxification,

antioxidation, energizing potencies and

promotion of depressed immunity.20 At

every turn, we are confronted with con-

sumables teeming with bacteria, the

Good Guys of the New Frontier.

It thus appears that the potential ap-

plications of probiotics in skin disease

are vast, as evidenced by the sampling

of studies above. Like any popular

“It-Girl,” probiotics are popping up ev-

erywhere, ranging from therapeutics to

cosmetics, foods and beverages. Yet,

also like “old wine in a new bottle,”21

probiotics merit a closer look and fur-

ther study to determine which strains

confer tangible benefits in which ap-

plications, among what patient popula-

tions and at which dosages. While it is

tempting to jump on the bandwagon of

broad utility, such enthusiasm must be

tempered with careful study and con-

sideration. DT

References

1. Bowe W, Patel NB, Logan AC. Acne vulgaris, pro-

biotics and the gut-brain-skin axis: from anec-

dote to translational medicine. Benef Microbes.

2014;5(2):185-99.

2. Parodi A, Paolino S, Greco A, et al. Small intesti-

nal bacterial overgrowth in rosacea: clinical ef-

fectiveness of its eradication. Clin Gastroenterol

Hepatol. 2008;6(7):759-64.

3. Muizzuddin N, Maher W, Sullivan M, Schnittger

S, Mammone T. Physiological effect of a probi-

otic on skin. J Cosmet Sci. 2012;63(6):385-95.

4. Di marzio L, Cinque B, De simone C, Cifone MG.

Effect of the lactic acid bacterium Streptococ-

cus thermophilus on ceramide levels in human

keratinocytes in vitro and stratum corneum in

vivo. J Invest Dermatol. 1999;113(1):98-106.

5. Kalliomäki M, Salminen S, Arvilommi H,

Kero P, Koskinen P, Isolauri E. Probiotics

in primary prevention of atopic disease: a

randomised placebo-controlled trial. Lancet.

2001;357(9262):1076-9.

6. Weston S, Halbert A, Richmond P, Prescott

SL. Effects of probiotics on atopic dermatitis:

a randomised controlled trial. Arch Dis Child.

2005;90(9):892-7.

7. Van der aa LB, Heymans HS, Van aalderen WM,

Sprikkelman AB. Probiotics and prebiotics in

atopic dermatitis: review of the theoretical back-

ground and clinical evidence. Pediatr Allergy

Immunol. 2010;21(2 Pt 2):e355-67.

8. Pelucchi C, Chatenoud L, Turati F, et al. Probi-

otics supplementation during pregnancy or in-

fancy for the prevention of atopic dermatitis:

a meta-analysis. Epidemiology.

2012;23(3):402-14.

9. Boyle RJ, Bath-hextall FJ, Leonardi-bee J,

Murrell DF, Tang ML. Probiotics for treat-

ing eczema. Cochrane Database Syst Rev.

2008;(4):CD006135.

10. Di marzio L, Centi C, Cinque B, et al. Effect of

the lactic acid bacterium Streptococcus ther-

mophilus on stratum corneum ceramide levels

and signs and symptoms of atopic dermatitis

patients. Exp Dermatol. 2003;12(5):615-20.

11. Di marzio L, Cinque B, Cupelli F, De simone C, Ci-

fone MG, Giuliani M. Increase of skin-ceramide

levels in aged subjects following a short-term

topical application of bacterial sphingomyelin-

ase from Streptococcus thermophilus. Int J Im-

munopathol Pharmacol. 2008;21(1):137-43.

12. Huseini HF, Rahimzadeh G, Fazeli MR, Meh-

razma M, Salehi M. Evaluation of wound

healing activities of kefir products. Burns.

2012;38(5):719-23.

13. Wong VW, Martindale RG, Longaker MT, Gurtner

GC. From germ theory to germ therapy: skin mi-

crobiota, chronic wounds, and probiotics. Plast

Reconstr Surg. 2013;132(5):854e-861e.

14. Shu M, Wang Y, Yu J, et al. Fermentation of Pro-

pionibacterium acnes, a commensal bacterium

in the human skin microbiome, as skin probiot-

ics against methicillin-resistant Staphylococcus

aureus. PLoS ONE. 2013;8(2):e55380.

15. Sikorska H, Smoragiewicz W. Role of probiotics

in the prevention and treatment of meticillin-

resistant Staphylococcus aureus infections. Int J

Antimicrob Agents. 2013;42(6):475-81.

16. Satoh T, Murata M, Iwabuchi N, et al. Effect of

Bifidobacterium breve B-3 on skin photoaging

induced by chronic UV irradiation in mice. Benef

Microbes. 2015;:1-8.

17. Ishii Y, Sugimoto S, Izawa N, Sone T, Chiba K,

Miyazaki K. Oral administration of Bifidobacte-

rium breve attenuates UV-induced barrier per-

turbation and oxidative stress in hairless mice

skin. Arch Dermatol Res. 2014;306(5):467-73.

18. Levkovich T, Poutahidis T, Smillie C, et al. Pro-

biotic bacteria induce a ‘glow of health’. PLoS

ONE. 2013;8(1):e53867.

19. Park KY, Jeong JK, Lee YE, Daily JW. Health

benefits of kimchi (Korean fermented veg-

etables) as a probiotic food. J Med Food.

2014;17(1):6-20.

20. Vina I, Semjonovs P, Linde R, Denina I. Current

evidence on physiological activity and expected

health effects of kombucha fermented bever-

age. J Med Food. 2014;17(2):179-88.

21. Kumar S, Mahajan BB, Kamra N. Future

perspective of probiotics in dermatology: an

old wine in new bottle. Dermatol Online J.

2014;20(9).

®

JULY 2015 ⁄ DERMATOLOGYTIMES.COM

18 IRREGULAR BORDER

PROBIOTICS:Kefi r gels from page 10

Probiotics may help to normalize disruptions in human microbial communities and bacteria-host interactions that contribute to non-healing wounds.

24 CLINICAL DERMATOLOGY

Scleroderma skin ulcers are challenging to manage and can be ap-proached with a variety of therapies and treatments, according to Alain Brassard, M.D., FRCPC, professor of  dermatology and medicine in the Department of Medicine at the University of Alberta in Edmonton, speak-ing at the annual meeting of the Canadian Association of Wound Care (CAWC).

In the case of scleroderma of the skin, approximately 35% of patients will eventually get cutaneous ulcers, according to Dr. Brassard.

“Scleroderma is a disease that is systemic and needs to be treated sys-temically to heal the ulcers,” says Dr. Brassard, in an interview with Der-

matology Times. “The ulcers are related to endothelial cells that are driv-ing the scleroderma. Raynaud’s phenomenon is usually present in many patients with scleroderma. That phenomenon may create digital ulcers that are horrible in terms of the impact on quality of life of patients.”

PHARMACOLOGIC APPROACHES

Pharmacologic approaches include vasodilators, which target Raynaud’s phenomenon, and agents aimed at endothelial cell protection such as Phosphodiesterase-5 inhibitors (sildenafil and tadalafil). Secondary Raynaud’s phenomenon linked with scleroderma can be more severe than primary Raynaud’s phenomenon.

Calcium-channel blockers have been shown to offer a significant benefit in managing Raynaud’s phenomenon because of the improve-ment in the frequency and severity of ischemic attacks.1

Another study has found that infusions of iloprost was a preferred therapy for acute necrosis. Scleroderma ulcers may herald pulmonary hypertension. Bosentan monohydrate, an endothelial cell protector, avoids vasoconstriction and has demonstrated that it is effective in pre-venting the formation of new digital ulcers as well as reduce the devel-opment of pulmonary arterial hypertension.2

Statins are agents that are immunomodulatory, vasodilatory and antifibrotic.3 The evidence, however, for their use in managing scle-roderma and systemic sclerosis is weak, as they have not been studied in large trials but could be considered and should be studied further.4

NEUROMODULATOR APPROACH

Another emerging medical therapy in the treatment of digital ulcers in patients with systemic sclerosis is botulinum toxin type A, which de-creases swelling, decreases pain and enhances perfusion of fingers by opening up the vasculature and permitting better oxygenation.

Clinicians should be cautious about injecting botulinum toxin so as not to cause excessive relaxation of the hand muscles. Injections should be initially limited to the fingers, with successive injections to the hand if necessary at subsequent visits.

Injection of botulinum toxin is a less invasive alternative to surgical sympathectomy, producing a chemical sympathectomy that will have a duration of several months.

Non-pharmacological management avenues include avoidance of cold, stress and trauma, as well as smoking cessation. On the horizon lie future treatments for sclerodermal skin ulcers, such as stem cell therapy. DT

Disclosures: Dr. Brassard has no relevant disclosures.

Scleroderma skin ulcersLOUISE GAGNON | STAFF CORRESPONDENT

WHICH APPROACH IS BEST?

See references and read the full article at: bit.ly/Sclerodermaskinulcers

25JULY 2015 ⁄ DERMATOLOGYTIMES.COM VIGNETTEDERMATOLOGY

as soon as you met him. He was the most

gentle, sweet, loving guy,” Dr. Green says.

THE END

As jovial, prominent and successful as he

was, Dr. Brandt suffered from a darkness

those who were close to him could feel

but not fix.

Going forward hasn’t been easy, says

Dr. Geronemus. “We have a lot of very

distraught patients. We have people call-

ing the office in tears. Patients coming in

in tears. “He had a very high level of cli-

entele and people who weren’t high level.

He treated them all well. And they were

truly his friends. The staff were very close

to him.”

Dr. Geronemus says Dr. Brandt

seemed bothered by a few things in the

weeks before his death, but Dr. Gerone-

mus didn’t sense the seriousness of his

business partner’s depression.

MEMORIAL FUNDS

In tribute to Dr. Brandt, the American

Society for Dermatologic Surgery (ASDS)

has set up two memorial funds.

The Allergan Foundation has commit-

ted $300,000 for the ASDS to administer

The Fredric S. Brandt, M.D., Innovations

in Aesthetics Fellowship Fund in col-

laboration with the Society’s accredited

cosmetic dermatologic surgery fellowship

training programs. The fund supports the

career development of junior dermato-

logic surgeon-scientists focused on cos-

metic treatments and patient care.

ASDS also has established the Fredric

S. Brandt, M.D., Memorial Research Fund

to support well-conceived clinical re-

search projects in cosmetic dermatologic

surgery or board-directed research relat-

ing to the safety of cosmetic procedures,

according to an ASDS press release.

“This Memorial Research Fund gives

Dr. Brandt’s friends, colleagues and in-

dustry partners a mechanism to honor his

memory in a way that is consistent with

who he was as a person and physician —

innovative, giving and collaborative — for

the benefit of the entire specialty,” says

ASDS President George J. Hruza, M.D.,

M.B.A.

For information about donating to

either fund, contact Tara Azzano at taz-

zano@asds.net or 847-956-9128. DT

Reference:

1. Grinnell, Sunhee. In Loving Memory of Dr. Fredric

Brandt (1949-2015). Vanity Fair. April 17, 2015.

Available online at: http://www.vanityfair.com/

style/2015/04/in-loving-memory-of-dr-fredric-

brandt-1949-2015

FREDERIC S. BRANDT:Farewell to the Baron of Botox from page 12

Read the full article:

bit.ly/Farewellfredericbrandt

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JULY 2015 ⁄ DERMATOLOGYTIMES.COMCOSMETIC DERMATOLOGY26

Dermatologists considering laser hair removal technology for their laser practices should go into it knowing the level of competition, their patients’ needs and that there are plenty of op-tions —some more effective than oth-ers, says Landon Pryor, M.D., plastic surgeon, Rockford, Ill., and clinical assistant professor of plastic surgery at University of Illinois.

“Before investing in any device, look at multiple vendors and find out… specif-ics, as far as what kind of clearance [to] expect. Is it 50% hair reduction, 100%, 90%? How many treatments are needed? What are the skin types [for treatment with the laser]?” Dr. Pryor says.

HAIR REMOVAL NUANCES FOR

THE DERMATOLOGIST

Terrence Keaney, M.D., clinical professor of dermatology and urology at George

Washington University Medical Cen-ter, and director of the men’s cosmetic center, W for MEN, at the Washington Institute of Dermatologic Laser Surgery, says dermatologists need to pay special attention to patient skin type when of-fering hair removal laser services.

“Typically, with hair removal, we prefer a little longer wavelength that is a little less specific to pigment to avoid any burning or scarring. For lighter skin types, using a more pig-ment-specific laser hair removal de-vice is nice,” Dr. Keaney says. “So, having a laser platform that can treat both is definitely an advantage, instead of having to buy a different device for

Using a lidocaine mix with

hyaluronic acid (HA) fillers to help

mitigate pain is not an uncommon practice.

But can adding epinephrine to lidocaine

further offset bruising and pain? A research

team investigated the severity of bruising and

pain in patients treated with the cohesive

polydensified matrix HA in three different

preparations: CPMHA (BEL), CPMHA

with lidocaine (BEL-L) and CPMHA with

lidocaine and epinephrine (BEL-LE).SOURCE: BIT.LY/HAFILLERS

28

29 ENERGY TECHNOLOGY 411

When it comes to energy devices, Dr. E. Victor Ross shares what does what

LASER SAFETY TIPS

Experts offer these laser safety tips

HAIR REMOVAL DEVICES see page 28

Hair removal lasers: are they right for your practice?LISETTE HILTON | STAFF CORRESPONDENT

If I were to grade thethree, I’d give non-abla-tive lasers an A-plus,ablative lasers an A andconventional resurfacing a B, due mainly torelatively long down-time for the patient.”

E. Victor Ross, M.D.

San Diego, Calif.

Energy devices: what does whatSee story page 29

Several factors come into play

when considering whether

to add laser hair removal to

the dermatologist’s practice.

Industry experts offer their

insights and advice.

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“With hair removal, we prefer a little longer wavelength that is a little less specific to pigment to avoid any burning

or scarring. For lighter skin types, using a more pigment-specific laser hair removal device is nice.”Landon Pryor, M.D.Rockford, Ill.

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28 COSMETIC DERMATOLOGY

darker skin types and a different de-vice for lighter skin types.”

M ichael H. Gold, M.D., medical direc-tor, Gold Sk in Care Center and Tennessee Clinical Research Cen-ter, Nashville, Tenn., says hair removal is his laser practice’s do-

main and a source for referral for other procedures. Dr. Gold’s practice has more than 40 devices.

“For hair reduction, I recommend the Soprano ICE 810 nm Diode with In-Motion technology (Alma Lasers). It is a very efficacious way to treat hair for all skin types,” says Dr. Gold. “The system has a 2.0 cm spot handpiece with con-tact cooling for treating large areas. The patients tolerate the virtually painless treatment very well, and my staff can treat a back in less than 20 minutes. This system has no consumables and has in-creased the volume in my laser center.”

Other laser hair removal diode sys-tems also work with vacuum technol-ogy to reduce pain and bring the tar-get closer to the light source, accord-ing to Dr. Gold.

“These technologies work great in my practice, as do some of the other wave-lengths for specific patients, including the Nd:YAG systems for some of my skin type VI individuals,” Dr. Gold says.

Being able to treat larger surface areas is a trend in hair removal, ac-cording to Dr. Keaney.

“In men, for example, we’re treating backs. In women we’re treating legs or bikini areas,” Dr. Keaney says. “With tra-ditional spot sizes that we’ve had in the past, that can take a long time. I think a lot of companies are [offering] newer technologies where they’re able to de-liver laser hair removal in much larger areas, dramatically decreasing the time in treatment, which is a big complaint with some hair removal cases.”

SAFETY, TREATMENT TIPS

Don’t take the safety of performing hair removal laser services for granted, says Dr. Pryor, who points out that this is a medical treatment and should be treated as such. “If the physician is not doing the treatment, …it needs to be delegated to a laser technician that is appropri-

ately trained in that device,” he says.According to Dr. Pryor, he consults

with patients before they begin hair removal treatment at his practice.

It’s also important to have clear staff rules on how they should proceed with large surface areas, says Dr. Keaney. “Sometimes when you’re treating for a long period of time, you can forget where you’ve previously treated, so [it’s important to carefully mark] certain areas where you’ve treated and have a very systematic approach,” he says.

IS LASER HAIR REMOVAL

RIGHT FOR YOUR PRACTICE?

Hair removal is popular and highly competitive.

Vic Narurkar, M.D., chairman of der-matology at California Pacific Medical Center, San Francisco, who has a cos-metic-only dermatology practice featur-ing 16 lasers, says dermatologists should think twice about investing in hair re-moval technology if they’re just getting started in lasers. With spas and non-derm practices in the mix of competi-tors providing the service, price wars are common. So, while having hair removal lasers makes sense in a comprehensive laser practice, dermatologists might first focus on less competitive areas, such as the treatment of vascular conditions, ac-cording to Dr. Narurkar. DT

HAIR REMOVAL LASERS:Device nuances from page 26

While having hair removal lasers makes sense in a comprehensive laser practice, dermatologists might first focus on less competitive areas.

For more articles like this:

bit.ly/Nonsurgicaltreatments

SAFE LASER operation practices protect not only patients but also

staff. Experts offer these as their top safety tips:

▶ Take a CourseBruce Katz, M.D., director of the Juva Skin and Laser Center in

Midtown Manhattan, recommends dermatologists follow strict laser

safety guidelines.

“People can learn those in a laser safety course. It’s like learning to

drive a boat or driving a car. You have to take a course and make sure

exactly what precautions to take,” Dr. Katz says.

▶ Train Staff AdequatelyTerrence Keaney, M.D., director of men’s cosmetic center at the

Washington Institute of Dermatologic Laser Surgery, in Washington, DC,

says dermatologists need to oversee proper training of the staff.

“It’s not see one; do one. [Staff] should log a signifi cant amount of

cases,” Dr. Keaney says.

▶ Have a Dedicated Safety Offi cer Vic Narurkar, M.D., who has 16 lasers at his cosmetic-only

dermatology practice in San Francisco, says dermatologists who

offer lasers should have a dedicated laser safety offi cer.

“You need to train your staff on optic… safety and that is all

done through the laser safety offi cer,” Dr. Narurkar says. “We have

one in our offi ce — that’s me. And I trained all my staff.”

Dr. Narurkar also recommends dermatologists capitalize

on the in-services and training that most of the manufacturers

provide.

▶ Pay Attention to DetailsSeemingly small precautions can make a big difference in the safety

of a laser practice, Dr. Katz says. One example: Patients should

never wear paper gowns. Why? They can catch fi re. Cloth gowns are

recommended for safety, according to Dr. Katz. DT

Laser safety tips

Michael H. Gold

29JULY 2015 ⁄ DERMATOLOGYTIMES.COM COSMETIC DERMATOLOGY

Given the number of conditions to treat as well as the ever-increasing variety of devices with which to treat them, even seasoned practitioners might need a re-fresher course on what devices do what. That’s according to E. Victor Ross, M.D., of Scripps Clinic, San Diego, who pre-sented “Energy Devices A to Z: What Does What,” at the inaugural Aesthetic + Medical Dermatology Symposia, held in Coeur d’Alene, Idaho, in May 2015.

Dr. Ross reviewed what devices work best for specific conditions, including facial rejuvenation (especially acne scars), red and brown spots, tattoo re-moval and skin tightening.

ENERGY FOR ACNE SCARS

For ease of use by the practitioner and little downtime involved for the patient, Dr. Ross gives his highest grade to non-ablative fractional lasers.

“Ablative lasers offer better results, but there’s more downtime involved,” says Dr. Ross. “Conventional resurfacing is still widely used, but if I were to grade the three, I’d give non-ablative lasers an A-plus, ablative lasers an A and conven-tional resurfacing a B, due mainly to the relatively long downtime for the patient.”

A new technology for treating acne scars is radio frequency (RF) needling, which uses a combination of radio fre-quency and needling to induce collagen production in the deeper skin layers.

He notes that vascular lesions bene-fit from pulsed dye, potassium titanyl phosphate (KTP) and intense pulsed light (IPL) lasers.

TATTOO REMOVAL

There’s new technology for removing tattoos,” Dr. Ross says. “The hottest new thing is the picosecond laser, which is a step up from the nanosecond laser in that it’s capable of removing tattoos with fewer treatment sessions. Still, some tattoos just don’t respond — to any de-vice we use — but it looks like picosec-ond lasers are trending for the future.”

Fractional lasers remain a choice for removing some resistant tattoos.

BROWN SPOTS, SCARS & SKIN TIGHTENING

For brown spots, “There’s a collage of dif-ferent things you can do,” Dr. Ross says,

citing fractional (especially thulium), Q-switched lasers, IPL and KTP lasers as the preferred tools for these indications.

When it comes to scars, fractional, Q-switched and vascular lasers remain the devices of choice, according to Dr. Ross.

“In this area, you basically find the par-ticular characteristic of the scar that differ-entiates it from normal surrounding skin, and then choose the most appropriate device to treat it with.”

The idea of replac-ing surg ica l proce-dures with energy de-vices for skin tighten-ing is appealing for pa-tients who want to want to turn back the clock without the expense of significant downtime.

“In reality, though, non-surgical ‘facelifts’ using energy devices only help temporar-ily or can defer a face-lift until later,” Dr. Ross explains.

COSMETIC VS MEDICAL

In keeping with the title of the meeting Dr. Ross made sure to differen-tiate.

“When we think of cosmetic versus med-ica l applicat ion for RF, ultrasound and laser devices, there are areas that can be clas-sified as medical, such as port wine stains, se-vere scars and birth-marks,” he says. “With these and other such conditions, we are often treating psychological as well as medical is-sues.”

As for the future of energ y devices, Dr. Ross had this predic-t ion: “They w ill be smaller, easier to use and more ergonomi-

cally friendly, and feature more sophis-ticated ‘navigational’ features to help in their use. They will provide more feed-back to the practitioner regarding proper settings by scanning — or even photo-graphing — the area being treated.” DT

Energy devices: what does what?BILL GILLETTE | STAFF CORRESPONDENT

®

JULY 2015 ⁄ DERMATOLOGYTIMES.COMCUTANEOUS ONCOLOGY30

Identifying specific neo-antigens in melanoma, a cancer known for hav-ing high numbers of genetic mutations caused by exposure to ultraviolet light, is no easy task. A melanoma biopsy typi-cally carries 500 or more mutated genes.

To date, vaccines have targeted non-mutated shared proteins expressed in normal and cancer cells. This has made it difficult to stimulate a robust immune response because the im-mune system does not see these pro-teins as foreign, says Gerald Linette, M.D., Ph.D., a Washington University medical oncologist.

Researchers recently published re-sults on the first human study1 look-ing at personalized vaccines designed to activate T-cells aimed at individual cancer patient’s mutations. The study, including three advanced melanoma patients, suggests these tailor-made vaccines boost T-cell number and di-versity, resulting in a tumor response.

The vaccines in this study are engi-neered based on which of the tumor-specific proteins altered due to DNA mutations are most likely to elicit a strong individual immune response, according to co-author Elaine Mardis, Ph.D., co-director of the McDonnell Genome Institute at Washington Uni-versity.

“In particular, our vaccine approach seeks to remind the patient’s immune system that these mutated proteins are truly non-self…,” Dr. Mardis says.

METHODOLOGY

Researchers sequenced the genomes of the patients’ tumors. They used mass spectrometry to identify neo-antigens on the tumors’ surfaces that were en-coded by specific mutant genes. The re-searchers selected a set of seven unique neo-antigens to engineer each vaccine, and used patient-derived dendritic cells to deliver the neo-antigens to the im-mune system. Each patient received three vaccine doses during about 18 weeks.

FINDINGS

Blood analyses revealed that each patient’s immune system responded to specific neo-antigens in the vac-cines. The vaccines stimulated di-verse clones of T-cells against neo-antigens, suggesting this approach also could be used to activate T-cells in other cancers with high mutation rates, such as lung cancer, bladder cancer and certain colorectal can-cers, according to a press release by Washington Universit y School of Medicine.

After receiving the individualized vaccines, the one patient who began the study in remission remains in re-mission, with no evidence of cancer. Regarding the other two patients, one patient had a transient two-month re-gression of lung metastasis while the other patient had stable disease, ac-cording to Dr. Linette’s comments at a news conference with the study’s re-searchers.

Total global spending on

oncology medicines –

including therapeutic treatments

and supportive care – reached the

$100 billion threshold in 2014, while

spending on oncology drugs in

the United States increased 5.3% compounded annual growth rate (CAGR) in 2014 to reach $42.4 billion, according to a new report.

SOURCE: BIT.LY/ONCOLOGYSPENDING

33

34 FDA ABOUT-FACE ON T-VEC

Approval comes days after accelerated schedule denied

‘ADDICTION’ MAY FUEL TANNING, RISK TAKING

Indoor tanning linked with risky behaviors

PERSONALIZED VACCINE see page 39

Personalized melanoma vaccines debut in humansLISETTE HILTON | STAFF CORRESPONDENT

Th ere’s a chance that patients who routinely tan also regularly engage in unprotected sex, binge drinking and illicit drug use.”

Hensin Tsao, M.D., Ph.D.

MauiDerm 2015

‘Addiction’ may fuel tanning, risk takingSee story page 33

Quotable DTExtra

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http://www.valeant.com/

33JULY 2015 ⁄ DERMATOLOGYTIMES.COM CUTANEOUS ONCOLOGY

Maui – Taken together, two new stud-ies suggest that among teens, indoor tan-ning is linked with other risky behaviors, and that tanners may be seeking a sort of natural high. This information may help dermatologists discuss healthy living in general with patients.

Recent data reflect a slight down-turn in tanning among teenagers, says Hensin Tsao, M.D., Ph.D., at MauiDerm. He is clinical director of the Massa-chusetts General Hospital Melanoma & Pigmented Lesion Center, director of the MGH Melanoma Genetics Pro-gram, and professor of dermatology at Harvard Medical School.

A national survey shows that the proportion of teens who had tanned indoors fell from 25.45% to 20.9% be-tween 2009 and 2011.1 Among the heavi-est users, non-Hispanic white females aged 16 years and up, the correspond-ing figures are 37% and 29%.

Perhaps more surprising are statisti-cally significant associations that sur-faced between indoor tanning and other risky behaviors, such as binge drinking (reported by 31.2% of female tanners and 6.2% of male tanners), unhealthy dieting (27.8% versus 9.3%, respectively) and sex-ual intercourse (29.6% versus 6.5%). For girls, the data also revealed statistically significant associations between tan-ning and sunscreen avoidance (24.9%), illegal drug use (28.4%), and having four or more sexual partners (26.6%).

Frequent tanners exhibit even more willingness to take risks, says Dr. Tsao. Among girls who tan more than 10 times

yearly, 55% to 65.5% reported sunscreen avoidance, binge drinking and steroid use without prescriptions.

Overall, Dr. Tsao says that by age 18, “Roughly one-third of all American high school girls probably have tanned. More importantly, there’s a chance that pa-tients who routinely tan also regularly engage in unprotected sex, binge drink-ing and illicit drug use.” And a similar biochemical buzz may drive all these ill-advised behaviors, he surmises.

In this regard, a mouse study has shown that, with respect to tanning, β-endorphins in the skin may drive ad-dictive behavior.2 UV damage to keratino-cytes produces hormone products in the skin including the pro-opiomelanocortin (POMC) gene, says Dr. Tsao. Components that split off this peptide include melano-cyte-stimulating hormone, which stim-ulates tanning. “The other component people don’t think about is a natural en-dogenous opiate, β-endorphin. Maybe this secondary product has some more central behavioral influence” than pre-viously recognized.

In the study, UVB-irradiated mice had higher serum β-endorphin levels versus unirradiated mice. Additionally, threshold pressure testing of the skin showed that irradiated mice could tol-erate more pressure and heat, suggesting that their skin had been anesthetized — an effect that the opiate antagonist nal-oxone reversed.

Giving irradiated mice naloxone pro-duced opiate withdrawal symptoms. And, when given a choice, irradiated mice avoided water infused with nalox-one in favor of pure water. “That’s addi-

tional evidence that they’re somewhat behaviorally addicted,” says Dr. Tsao.

Although tanning beds provide largely UVA rather than UVB, he says, “The study is intriguing. UVB creates mutations in the skin. Perhaps the gen-esis of this pathway is sunburn pain.”

If tanning is truly a component of global risk-taking behavior, “That has much less to do with mutations in the skin than with the brain’s pleasure cen-ter.” Ultimately, he’d like to see studies showing convincingly that tanners have higher β-endorphin and opiate levels — and then investigating whether opiate antagonists could curb humans’ urge to tan.

For now, he says that, when counsel-ing patients who tan, dermatologists can consider it an opening to discuss whether they’re engaging in other risky behaviors. “Tanning may be an oppor-tunity to open a dialogue about risk be-haviors and healthy living overall.” That includes eating five servings of fruit or vegetables daily — another healthy habit that tanners in the survey shunned. DT

Disclosures: Dr. Tsao serves on the editorial boards

of several dermatology journals and has received re-

search funding from the National Institutes of Health

and the American Skin Association.

References

1. Guy GP Jr, Berkowitz Z, Tai E, Holman DM, Ever-

ett Jones S, Richardson LC. Indoor tanning among

high school students in the United States, 2009

and 2011. JAMA Dermatol. 2014;150(5):501-11.

2. Fell GL, Robinson KC, Mao J, Woolf CJ, Fisher DE.

Skin β-endorphin mediates addiction to UV light.

Cell. 2014;157(7):1527-34.

‘Addiction’ may fuel tanning, risk-takingJOHN JESITUS | STAFF CORRESPONDENT

y voice of the dermatologist

“We have been struggling for generations to make the

best treatment recommendations for children with

severe AD. Finally, we have hope for the chance to offer them better options in the foreseeable future.”

Elaine Siegfried, M.D.See Pediatric trials for AD systemic treatments, page 14

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JULY 2015 ⁄ DERMATOLOGYTIMES.COM

34 CUTANEOUS ONCOLOGY

Two days after it reported that the Food and Drug Administration had denied accelerated approval to Amgen exper-imental melanoma drug talimogene laherparepvec (T-Vec), Reuters reported that an FDA advisory panel voted to approve the drug for marketing.

Dermatology Times discussed the approval with Wm. Philip Werschler, M.D., FAAD, FAACS, Associate Clin-ical Professor at University of Wash-ington School of Medicine in Seat-tle, Wash.

“Globally, the treatment of mela-noma has advanced greatly in the past 5 years. It appears that we are on the cusp of significant success in the med-ical management of melanoma, some-thing that heretofore was the domain of surgical management.

“Because of the culm inat ion of many decades of dedicated research on the genetics and biological be-havior of melanoma, and tumor re-sponse to various medical interven-tions, today there exists a variety of anti-tumor drug options of various types and classes. The medical on-

cologist, in consultation with derma-tologists, internists and surgeons is at the same time fortunate and bewil-dered in terms of selecting the best and most efficacious and most appro-priate drug therapy options for the in-dividual melanoma patient. Truly, the era of personalized medicine is upon us with regard to melanoma therapy.

“The seemingly confusing about-face of the FDA with regard to Amgen’s T-Vec investigational drug perhaps is better examined in the perspective of a very rapidly changing landscape of melanoma therapy. I applaud the FDA for having the insight and cour-age to face criticism and be willing to reexamine facts to arrive at a differ-ent conclusion from one reached just days earlier.”

Reuters repor ted Apri l 27 t hat FDA staff reviewers said they could not consider an accelerated review of T-Vec — an engineered virus that kills cancer cells when injected into tu-mors and primes the immune system to attack the disease — due to con-cerns over the design and results of a key study. Specifically, an indepen-dent panel said it questioned whether

the immunotherapy improved over-all survival of patients.

Also on April 27, Medical Marketing & Media reported that the recent ap-proval of drugs such as Merck’s Key-truda and Bristol-Myers Squibb’s Op-divo — unavailable when Amgen started testing in 2009 — reduced the urgency of an accelerated-approval designation for T-Vec. According to MM&M, Amgen and Merck signed a deal last year to ex-plore how T-Vec worked with PD-1 in-hibitor Keytruda.

Then, on April 29, Reuters reported the FDA’s ruling that T-Vec had shown enough efficacy to earn marketing approval. According to another re-port by Medscape Medical News, the recommendation for approval came from two advisory panels: the Onco-logic Drugs Advisory Committee and the Cellular, Tissue and Gene Thera-pies Advisory Committee, members of which voted 22-1 to approve.

T-Vec contains a genetically mod-ified version of the herpes simplex virus, engineered to replicate in the tumor and destroy cancer cells.

The drug also is being considered for approval in the European Union. DT

Researchers conducting a first-of-its-kind study combining the checkpoint inhibitor tremelimumab with an anti-CD40 monoclonal antibody drug report the dual treatments are safe and pro-duce a clinical response in metastatic melanoma patients.

Researchers presented the abstract for the Phase I trial during the Amer-ican Association for Cancer Research (AACR) 2015 meeting in Philadelphia.

“… New treatment protocols com-bining immunotherapies are coming. This is the first combination of an im-munostimulatory agent with check-point blockade,” says lead author

David Bajor, M.D., instructor in the hematology/oncology division in the Perelman School of Medicine, Univer-sity of Pennsylvania. “When they are thoughtfully combined with immune-stimulating compounds like CD40 or drugs targeting other facets of the im-mune system, we hope to be able to in-crease the response rate to previously approved therapies.”

While researchers were concerned that the combination could increase side effects, that didn’t happen in this study.

“Generally, the adverse event pro-file seen in this particular combination (agonistic CD40 and tremelimumab) is similar to that of each drug alone,” Dr. Bajor says. “The most significant der-

matologic toxicity we saw was pruritus. Notably, several of our patients who did very well and, thus, were on the com-bination for many months had grade 2 pruritus with or without a macu-lar/papular rash. Identifying non-cor-ticosteroid based treatments for this side effect could greatly improve the comfort and quality of life for patients receiving this type of treatment, while allaying the oncologists’ fears of damp-ening the immune response.”

Dr. Bajor has no relevant disclo-sures. DT

FDA OKs melanoma drug after

denying it accelerated approval

Immunotherapy combo appears safe,

shrinks metastatic melanoma tumors

BILL GILLETTE | STAFF CORRESPONDENT

LISETTE HILTON | STAFF CORRESPONDENT

Read the full article at:

bit.ly/melanomacombosafe

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JULY 2015 ⁄ DERMATOLOGYTIMES.COM

36 CUTANEOUS ONCOLOGY

although it may not be the most impor-tant one or the most frequent problem you see, is malignant transformation of the nevi. However, another significant concern is the stigmatization of these pa-tients, as well as the limited treatment options of these lesions, which can be difficult to manage because surgeries can be quite challenging to perform and are typically multiple,” says Dr. Reyes-Múgica.

According to Dr. Reyes-Múgica, these typically complex and staged surgeries can also sometimes be disfiguring. The success of treatment often depends on the location of the nevus and its unique pattern or thickness, as well as the indi-vidual patient’s idiosyncratic ability to repair tissues.

“There are several different factors that need to be taken into considera-tion when deciding on the appropriate treatment approach for CMN lesions. Each case must be approached individ-ually, as no one treatment strategy fits all,” says Dr. Reyes-Múgica.

Dr. Reyes-Múgica and colleagues re-cently published their results of a pro-spective study that investigated the asso-ciation between the standardized clin-ical features of CMN and large/giant CMN in a large patient cohort, with the mutational status of NRAS Q61 and BRAF V600 in nevi lesions.1

The ongoing study included 66 CONGENITAL MELANOCYTIC NEVI see page 39

CONGENITAL MELANOCYTIC NEVI:BRAF gene mutation breakthrough from page 1

Not only could an association between BRAF

mutations and large/giant CMN be identified, but there is also a clear association with the BRAF-mutated gene and NCM.

Proliferative nodule arising in a GCMN. Note the upper portion with scattered nevus cells surrounding a hair follicle in the upper center. The lower portion of the image shows a highly cellular lesion with small nevus cells (proliferative nodule) (H&E, 10X).

Photo credit: Miguel Reyes-Múgica, M.D.

Brain cortex of a patient with neurocutaneous melanocytosis (NCM) showing pigmented NCM cells in the leptomeninges and infiltrating through the perivascular Virchow-Robin spaces (H&E, 4X).

Photo credit: Miguel Reyes-Múgica, M.D.

Classic low power histological view of a GCMN. Note the impressive thickness of the lesion, involving subcutaneous tissue and replacing dermal components (H&E, 4X).

Photo credit: Miguel Reyes-Múgica, M.D.

GCMN stained with HMB45 immunohistochemistry. The lesion involves fascial plane and replaces the subcutaneous tissue and dermis (HMB45, 4X).

Photo credit: Miguel Reyes-Múgica, M.D.

what familiar with CMN (congenital melanocytic nevi) and NCM (neurocu-taneous melanocytosis), the average cli-nician may be overwhelmed when con-fronted with such a patient regarding therapy and management. Therefore, it is important that clinicians not only recognize this significant issue but also become more familiar with the current treatment approaches as well as those in the pipeline,” says Miguel Reyes-Múgica, M.D., Chief of Pathology and Director of Laboratories, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, Penn.

CMN are benign proliferations of mu-tant melanocytes (nevomelanocytes) that are typically present at birth or de-velop shortly after birth, and can loosely

be categorized into small (< 1.5 cm di-ameter), medium (1.5-10 cm), large (11-20 cm), and giant (>20 cm diameter) lesions.

Large and giant CMN lesions are par-ticularly associated with a set of compli-cations that include decreased sweating, xerosis, pruritus and skin fragility. Pa-tients also experience altered or dimin-ished tissue growth due to the hamar-tomatous and infiltrative nature of the lesions; a higher complexity of surgical removal; and childhood psychological problems secondary to cosmetic issues and social stigmatization.

CMN are also associated with an in-creased lifetime risk of malignant trans-formation to melanoma as well as the risk for NCM, a proliferation of nevomelano-cytes in the leptomeninges and brain pa-renchyma, further underscoring the ur-gency to address these lesions appropri-ately and in a timely manner.

“The biggest worr y with CMN,

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38 TRADE TOOLS

Neossance squalane skin solution AMYRIS introduces Neossance squalane skin solution, which, according to

the company, is derived from plant sugar and is a high-purity, high-quality,

sustainable replacement for squalane. Neossance is a fully saturated, non-polar

hydrocarbon. Squalene is naturally present in the skin’s lipid barrier, preventing

moisture loss while restoring the skin’s suppleness and flexibility. Squalane’s

exceptional moisturizing properties and ability to penetrate the skin have made

squalane a long time favorite amongst cosmetic formulators. According to the

company, Neossance offers a silky, smooth and elegant texture without a greasy,

heavy after feel.

AMYRIS

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39JULY 2015 ⁄ DERMATOLOGYTIMES.COM CUTANEOUS ONCOLOGY

t ions were found to be associated w it h increased dermal/subcuta-neous nodules, only 32% of the N R A S -mu t a t e d nevi were associ-ated with this finding. Results also showed that NCM affected 16 (24.2%) of 66 patients, where the NRAS and BRAF

mutations occurred in 12 (75%) and 2 (12.5%) patients, respectively, with 2 patients (12.5%) negative for both mutations.

These results are important because not only could an association between BRAF mutations and large/giant CMN be identified, but there is also a clear association with the BRAF-mutated gene and NCM. Although the propor-tion may still be predominantly NRAS-mutated, Dr. Reyes-Múgica says that the BRAF-mutated nevi could poten-tially be approached differently with

potential targeted treatment, such as BRAF inhibitors that could ultimately either prevent or decrease the proliferation of nevus cells. DT

Disclosure: Dr. Reyes received a

donation (20K) from Mr. and Mrs.

Travis Bailey, which was matched by

Nevus Outreach, Inc., to support his Tis-

sue bank (a total of 40K). His work was partly

supported by that donation.

Reference:

1. Salgado CM, Basu D, Nikiforova M, et al. BRAF

mutations are also associated with neurocu-

taneous melanocytosis and large/giant con-

genital melanocytic nevi. Pediatr Dev Pathol.

2015;18(1):1-9.

CONGENITAL MELANOCYTIC NEVI:BRAF gene mutation breakthrough from page 36

“We found t hat each pat ient’s immune system recognized three of the seven neo-antigens that were for-mulated in the vaccine,” says lead au-thor Beatriz Carreno, Ph.D., associate professor of medicine at Washington University School of Medicine.

Research collaborators at the Uni-versity of Oklahoma Health Science Center confirmed the presence of these neo-antigens as flags on the surface of each patient’s melanoma cells. They observed that all three patients had pre-existing immunity to at least one neo-antigen, and vaccination re-vealed new immunity to two additional

neo-antigens, according to Dr. Carreno.An unexpected finding from im-

munologic studies is that vaccination promotes a highly diverse repertoire of neo-antigen specific T-cells, suggest-ing that cancer patients might have in reserve a pool of naïve tumor specific T cells that remain dormant unless ac-tivated by vaccination.

The study, says Dr. Carreno, high-lights a new approach that merges cancer genomics with immune cell therapy to develop personalized den-dritic cell vaccine that activates T cells against neo-antigens.

“We think our findings represent

a significant step towards more per-sonalized immunotherapy,” she says.

Fut u re appl icat ions for t hese personalized melanoma vaccines might be for patients postsurgery, to stimulate the immune system to attack remaining cancer cells and prevent recurrence. This proof-of-principle study sets the stage for an FDA-approved phase I vaccine trial that will enroll six melanoma patients. DT

PERSONALIZED VACCINE:First human study from page 30

High power view of a temporal lobe from a patient with NCM showing pigmented cells infiltrating the brain parenchyma. Note melanin pigment also present within neurons (H&E, 40X).

Photo credit: Miguel Reyes-Múgica, M.D.

BRAF-mutated nevi could potentially be approached differently with potential targeted treatment that could prevent or decrease the proliferation of nevus cells.

patients (40 female and 26 male) with 8 medium, 21 large and 36 giant CMN le-sions. One patient had only a melano-cytic lesion from the brain and no clin-ical data. The main nevus size ranged from 6-80 cm (mean 31.5 cm), and satel-lite nevi count ranging from 0-300 (mean 58.9). At the time of initial surgery, pa-tient ages ranged from 6 months to 18 years, with 51 patients younger than 3 years of age. Patient demographics in-cluded 48 Caucasians and 15 Asians, with information about race unavaila-ble in three patients.

Data showed that NRAS and BRAF

mutations were present in 51 (77.3%)

and 5 cases (7.6%), respectively, with 10 cases (15.2%) negative for both mu-tations. While NRAS mutations were found in 5 (62.2%) of 8 medium, 15 (76.2%) of 21 large, and 29 (80.6%) of 36 giant CMN lesions, BRAF mutations were seen in 1 (4.8%) of 21 large and 4 (11.1%) of 36 giant CMN, with no BRAF

mutations found in medium CMN le-sions. While 100% of the BRAF muta-

See references and read the full article:

bit.ly/personalizedmelanomavaccine

100%of BRAF mutations are associated with increased dermal/

subcutaneous nodules

®

JULY 2015 ⁄ DERMATOLOGYTIMES.COMBUSINESSOF DERMATOLOGY40

Conducting clinical trials is one way for a practice to collaborate in the development of new drugs and devices, according to Kenneth Beer, M.D. He is a West Palm Beach, Fla.-based der-matologist in private practice as well as associate clinical professor of der-matology, University of Miami Miller School of Medicine; consulting asso-ciate, Department of Medicine, Duke University; and clinical associate in dermatology, University of Pennsyl-vania Perelman School of Medicine.

Clinical trials also can provide a great opportunity for patients to get treatments before they are in the main-stream, he says.

THE CLINICAL TRIAL SET-UP

Ideally, says Dr. Beer, a practice’s clin-ical-study business should have a sep-arate location, corporate structure and staff.

W h i c h e v e r r o u t e a p r a c t i c e chooses, says Dr. Beer, “It ’s ver y important that you have one full-time study coordinator. Find some-body who’s interested in clinical tri-als. They may not be highly experi-enced,” but this person must be fa-miliar with good clinica l pract ice and open to learning the clinica l-trial ropes.

WHAT YOU NEED TO KNOW

Along with good clinical practice, Dr. Beer says that physicians and their staff also must be familiar with informed con-sent, recruitment, budgeting, negotiat-ing and space and staff requirements.

Furthermore, “Sponsors will look to see if you’re really serious about it” and have a dedicated location with its own staff. Conversely, “If your front desk girl does your clinical coordinating while running charts around and answering the phone, it doesn’t look good.”

Often, he says, drug companies will initiate trials by approaching experi-enced investigators. If this happens, “You can pick and choose which ones you’ll participate in. The downside is, you must toe the line. You can’t create anything new” in the study protocol.

Travel to investigator meetings also is required, he says, as is hosting mon-itoring visits from sponsors and/or the FDA. “Sometimes the sponsors want face time. And every time a monitor comes in, even if it’s for five minutes, you have to meet with them” and an-swer any questions they may have. “They open up your books; they want to see what you’re doing.”

Investigator-initiated trials, on the other hand, require one to generate an idea, such as a new use for a neuromod-ulator, and propose it to a company or other potential sponsor, says Dr. Beer.

This process is difficult, he says, “be-cause you must come up with 10 ideas for everyone that will be accepted.”

TIPS FOR TRIAL SUCCESS

Of greater concern, he says, is that slop-piness and dishonesty in clinical tri-als can bring trouble from the FDA. In one such case, “A physician’s assistant was doing trials and patient care at the same time and was found to be making up data. The FDA shut the site down.”

Additionally, “Recruiting can be dif-ficult.” If your practice lacks a strong pa-tient base and/or staff and fails to recruit the patients required for a study, says Dr. Beer, the sponsoring company will be disappointed because it will have spent money initiating your study site.

Above all, says Dr. Beer, “Don’t just do clinical trials for money. However, if you’re interested in practice diversity, and it’s the type of thing that intellec-tually fascinates you, it can be a good direction to take.” DT

Disclosures: Dr. Beer is the owner of ScientificRx Sk-

incare. He has been a consultant and/or investigator

for Allergan, Merz and Valeant, and virtually all mak-

ers of cosmeceuticals and in-office products. He also

is a cofounder of The Cosmetic Bootcamp.

Botox-maker Allergan has agreed to

acquire Kythera Biopharmaceuticals and

along with it deoxycholic acid (Kybella),

recently approved by the Food and Drug

Administration for treating moderate-to-

severe submental fat in adults. The cash-

and-stock transaction was valued at

about $2.1 billion, according to reports.

SOURCE: HTTP://BIT.LY/ALLERGANKYTHERA

How to start a clinical trial programJOHN JESITUS | STAFF CORRESPONDENT

Dermatology is thought to be suffi ciently diversifi ed to have upside potential even in diffi cult times.”

David Wagener, M.B.A., C.P.A.

AAD 2015, San Francisco, Calif.

To sell or not to sell...that is the questionSee cover story

Quotable DTExtra

Read the full article at

bit.ly/Startingclinicaltrialprograms

41 TO SELL OR NOT TO SELL

Expert information about the pros, cons, and how-to’s of selling a practice

41JULY 2015 ⁄ DERMATOLOGYTIMES.COM BUSINESSOF DERMATOLOGY

financial growth, according to Wagener. “[Private equity firms] acquire a plat-

form group and then acquire compli-mentary add-on practices and open of-fices de novo to grow,” he says. “Derma-tology is thought to be sufficiently diver-sified to have upside potential even in difficult times.  We have the ability to provide both medically necessary serv-ices that are covered by third party pay-ers (which are always at risk of payment reductions) and non-covered elective services that are cash on delivery.”

WHAT MAKES A PRACTICE VALUABLE?

Practice valuation drivers include:➧ Offering general and cosmetic der-

matology➧ Offering Mohs surgery➧ Using nurse practitioners or phy-

sician assistants effectively➧ Having in-house pathology➧ Being located in a geographically

desirable place

However, when it comes to valuing a practice, things aren’t always black and white, according to Wagener.

“A more diverse and sophisticated practice that is large is attractive as a platform investment. Small prac-tices that are diverse and sophisti-cated may actually be less attractive as add-ons than less diverse prac-tices, because the name of the game with add-ons is to grow them and ex-pand the service offerings and im-prove them to create value,” he says.

Investors determine a practice’s value based on a multiplier, which can vary, applied to Earnings Before Interest, Tax, Depreciation and Am-ortization (EBITDA). Wagener ex-plains that EBITDA is an industry standard measure of free cash f low.

“In most physician practices there is no EBDITA per se, there is only phy-sician income. The amount of income a physician or group of physicians

earn above and beyond the norm (whatever that is) is what can be re-characterized as earnings and sold,” Wagener says.

FINDING A BUSINESS PARTNER

Financial buyers interested in derma-tology practices include firms look-ing to acquire platforms in the derma-tology space and existing companies wanting to build scale, according to Wagener. While small practices are likely to sell to established consoli-dators, a platform level dermatology group has the option of aligning with a new entrant.

“There are lots of other private equity firms who want to get in the door.  You want to sell to a group that has plenty of capital in reserve to con-tinue to invest in growing the busi-ness,” he says.

Dermatology practices that want

TO SELL OR NOT TO SELL:Strategies for your practice from page 1

TO SELL OR NOT TO SELL see page 42

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42 BUSINESSOF DERMATOLOGY

to sell might also turn to sell side advisors. “These are folks that will work for the sellers (the dermatologists) to help them find the best partner … and/or help them negotiate terms when a specific deal is being done with someone that approached them out of the blue. Some-times a practice that gets an unsolicited offer may choose to shop around for a better offer,” Wagener says.

THE BIG DECIDE

There are advantages to partnering with a growth equity firm. Among them: it can position physician partners to monetize equity value in the practice, according to Wagener. It might free dermatologists from debt or from concerns about the fu-ture of medicine and provide a more pre-dictable career journey. Sellers may retain some ownership and thus have the op-portunity to participate in the increased equity value as the group grows in size and profitability.

But that’s not always the case. Like with any partnership, an unhappy union can lead to trouble.

“I know physicians who sold their practices and when the buyer later failed

they bought it back for pennies on the dol-lar. Unfortunately they also experienced disruption in their practice and their cash flow during the transition.  I know physi-cians who have been left in a lurch when their employer went out of business,” Wagener says. “That said, I don’t mean to suggest that all the deals are going to fail. I do think it should be pointed out that if things go sour, the doctors’ entire world is disrupted. For the private equity guys, this is just one of a hundred things they are involved in and they go on with their lives without looking back.”

FIVE STEPS FOR THE SELL

“Different dermatologists will have dif-ferent goals,” Wagener says. “Someone older may want to sell and retire ASAP. Someone younger may have the goal of being part of building a big business and making money on the stock play. Some-one else might be so pessimistic about the future they just want to pass the risk to someone else and just be an employee.”

If you decide to sell, there are five clear steps.➧ Determine compensation and own-

ership structures.

➧ Value the practice.➧ Perform due diligence, including get-

ting a handle on a number of impor-tant practice aspects, from having a detailed review of the business to coding and compliance, to account-ing books and records and more.

➧ Agree on a price with an investor for a percentage of the practice, and ex-ecute the sale, distributing the money to physician partners. “These are basi-cally ‘scrape deals,’ meaning the phy-sician or physicians sign a long-term agreement to work for less and leave earnings on the table. Those earn-ings will be the basis of the valuation. The valuation goes up and down with earnings,” he says. “Sellers and buy-ers also need to agree on whether the payment is all cash or part cash and part stock in the new company. Sell-ers who take stock are betting that the company will be a success and the value of their stock will appreci-ate and make the value of what they received for their practice that much higher.”

➧ Grow the practice and ultimately exit. DT

TO SELL OR NOT TO SELL:Strategies for your practice from page 41

5 good reasons NOT TO SELL5 good reasons TO SELL

Suitor’s business plan

seems incomplete, is not understandable

or just does not seem viable.

Principals are within a few

years of their target retirement date and like the idea of monetizing

their equity in the practice.

Business terms are not

considered favorable (price, post-acquisition

employment contract terms,employment agreement renewal terms, control

issues, etc.).

The business

operations are faulty.

Lack of consensus in situations

where there are multiple owners.

Principals built their

practice with such a transaction in

mind.

he

Principals are carryingheavy debt

loads.lo

s,

Principals are optimistic

about the future andbelieve they can achieve

their goals without aligning twith business partner whow

can provide capital andshare risk.

Principals are worried

about the future andsee safety in aligningwith business partner

who can providecapital and share

risk. Principals lsare unwilling to

cede control to new owners.

2015Discussions in Dermatology

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TAKEAWAYTHE44

JULY 2015 ⁄ DERMATOLOGYTIMES.COM

Clinical pearls in pediatric dermatologyPediatric dermatology is a rewarding area of special interest for dermatologists.

Overlapping conditions, the need for extra-gentle skin care, patient compliance,

and medication adherence all present unique challenges for pediatric

dermatologists. In part one of our discussion, Kelly Cordoro, M.D., associate

professor of dermatology and pediatrics at the University of California in San

Francisco, discusses differentiating diseases and treatment recommendations

with Dermatology Times editorial advisor, Elaine Siegfried, M.D.

the research aspects of disease, but I found myself profoundly fascinated with the skin manifestations of all of these asthma patients that were com-ing into our clinical trials. I knew I wanted to pursue this interest further.

DR. SIEGFRIED: Is that what inspired your special

interest in severe inflammatory skin disease?

A Dr. Cordoro: I feel most excited by and intellectually curious about this

group of patients. I could only see one subset of patients for the rest of my ca-reer, I would let my clinic fill with pso-riasis, pityriasis rubra pilaris, connec-tive tissues disease, graft-versus-host disease, and the like.

ELAINE SIEGFRIED, M.D.: What inspired your ca-

reer choice in pediatric dermatology?

A Kelly Cordoro, M.D.: My career choice in pediatric dermatology ac-

tually came as somewhat of a surprise to me. When I was a dermatology res-ident at University of Virginia, I really saw my future as a general academic dermatologist who wanted to incor-porate kids into my practice. To dive a little bit further into that, as a derma-tology resident, I spent a month with Ilona Frieden, M.D., professor of der-matology and pediatrics at UC San Francisco, to expand my knowledge and experience with kids because we didn’t have a pediatric dermatologist at the University of Virginia. That month actually turned out to change the course of my career in full.

I was quite inspired. I returned to UVA and joined the faculty there. Two years later, I moved to San Fran-cisco to do a pediatric derma-tology fellowship! I was completely sold.  The diseases are fascinating, the scope is broad, the patients are complex, and really the extra challenges of under-standing skin disease in the con-text of rapidly evolving human beings with a different physiology as well as different developmental and psycho-social dynamics at various ages was really intellectually compelling to me.

DR. SIEGFRIED: Can you talk about your career

prior to medical school?

A Dr. Cordoro: Before I went to medi-cal school, I spent two years as a re-

search associate for Dr. David Skoner, an allergist/immunologist at Chil-dren’s Hospital of Pittsburgh. So I did have a foray into pediatrics and into

DR. SIEGFRIED: I am sure you see lots of eczema,

psoriasis, atopic dermatitis and contact derma-

titis. How do you distinguish between all of these

diagnoses?

A Dr. Cordoro: Distinguishing be-tween atopic dermatitis and pso-

riasis in very young and actually even older children can be really difficult. The two often overlap. In my observation, sometimes I find myself diagnosing eczematous pso-riasis or psoriasiform eczemas, re-ally a hybrid between those two di-agnoses. I’ll try to use cutaneous clues to point me one way or an-other. Details about lesional mor-phology; distribution; special sites; what’s the overall state of the skin; are they widely xerotic or are they not; is there gluteal involvement? If the family history and medical con-text doesn’t help me, I don’t rou-tinely perform biopsies to sort it out, because fortunately the basic management approach is similar for both conditions. Certainly atopic dermatitis far exceeds the preva-lence of psoriasis but sometimes I do find it to be very challenging to disentangle the two, and I am not sure how relevant it is at the earliest stages in the youngest kids.

DR. SIEGFRIED: Would you agree that contact

dermatitis often complicates atopic dermatitis

and psoriasis?

A Dr. Cordoro: Absolutely. I think dif-ferentiating atopic dermatitis from

contact dermatitis is one of the most difficult clinical problems I face. If I think there is probably an overlap, I’ll treat for a period of time as I would for atopic dermatitis, and then if it evolves in a characteristic way or doesn’t re-spond to treatment, I’ll pursue patch

Listen to the discussion.

bit.ly/Clinicalpearlspedederms

ELAINE SIEGFRIED, M.D.

“If I could only see one subset of patients for

the rest of my career, I would

let my clinic fill with psoriasis, pity-riasis rubra pilaris, connective tissues disease, graft-ver-sus-host disease, and the like.”Kelly Cordoro, M.D.San Francisco, Calif.

®

TAKEAWAYTHE45

JULY 2015 ⁄ DERMATOLOGYTIMES.COM

face area to clear to even patch test, and I think in the beginning, even if you are faced with allergic contact dermatitis, the goal no matter what is to treat and clear as best we can.

I have been very lucky. UCSF has a really rich tradition of expertise in patch testing with Dr. Howard Maibach, M.D., and now our newest faculty member, Nina Botto, M.D., who came to us from Tufts University. I refer the kids for whom I am most suspicious and just cannot get them clear for any period of time or at all.

DR. SIEGFRIED: For kids who have psoriasis or

eczema or inflammatory skin disease and who are

using topical treatment only, how do you monitor

medication adherence?

A Dr. Cordoro: I don’t have the tricky tubes and jars that monitor how

many times the lid has been taken off that Dr. Steven Feldman made famous in his studies on topical compliance. So for the lack of having trickery up my sleeve, I really just follow clinically. I think the most important thing is to as-sume that the prescribed therapeutic regimen is adequate to manage the dif-ferent components of the disease. I as-sume that if I have given the right regi-men and they are not responding, then there is either an overlapping factor that I missed and need to address or they’re not compliant.

I think the other clinical pearl that I have learned over time is that we re-ally need to consistently review what is actually being used and how it’s being used to assure that what we have pre-scribed has been translated into the proper use of that agent. These regi-mens are not straightforward, and what the patient is actually using and how they are using it may not even closely resemble what we recommended. Med-ication adherence and compliance is really tricky because there are so many moving parts, and that’s part of the fun and challenge of it all.

DR. SIEGFRIED: The effort required to monitor the

actual medication and quantities used can be a

nightmare. I would say 70% of people probably

don’t use adequate amounts and maybe 20% use

too much. I rarely give refills. I prefer that the pa-

tient call their pharmacist to fax the refill request,

so we know when they get their refills. Monitoring

adherence is an important but difficult problem.

There’s no right answer.

A Dr. Cordoro: I think one of the chal-lenges also is the psychological war-

fare that we play when a patient gets a prescription. For example, if we write “450 gram tub” for very widespread, se-vere disease, and the pharmacy sup-plies only a 60 gram tube, a parent be-comes concerned about how much to use given the limited quantity sup-plied. At the pharmacy, patients are often given advice, for example, told not to use the prescription for more than 2 weeks; parents are told that they shouldn’t be using the prescription on their 5-year-old child, etc., but they wait for 3 months to come back to tell you that.

Earlier in my career I became frus-trated, even angry, when I would hear this, and I would call pharmacies and rant and rave. I think a lot of these really complex inflammatory disease patients aren’t really getting the time that they need from the doctor in that regard. We need to really educate them that we are skin experts who are prescribing the medication this way for a reason, be-cause once they leave your clinic, they are open to the world, and I think that’s when modifications happen.

DR. SIEGFRIED: We have a number of problems with

very limited formularies. Do you face that chal-

lenge?

A Dr. Cordoro: Absolutely, all the time. I will say this: I feel very for-

tunate that one of the lessons I learned very early in my residency at the University of Virginia was to be cost-conscious. I rarely write for branded medication if there is a suitable generic alternative. And this actually plays into my favorite part of dermatology: The art of mastering the treatment of skin diseases and the ability to find alter-nate regimens and generic regimens that work, as well as compounding.

If we can get a pharmacist to make a cream for diaper dermatitis with inex-pensive ingredients by mixing a little hydrocortisone, a little Nystatin, and a little zinc oxide, you can save the pa-

testing if I remain suspicious for contact dermatitis.

DR. SIEGFRIED: For kids whose primary skin dis-

ease you think is more psoriasis than eczema, do

your initial treatment recommendations differ?

A Dr. Cordoro: I think the only sig-nificant difference initially is that

I’ll spend a lot more time on the im-portance of the concepts of gentle sk-incare, the skin barrier and preserving and restoring the barrier in kids with atopic dermatitis. In terms of selecting a treatment regimen, it’s very similar with a few exceptions — like including a vitamin D analog for psoriasis that we wouldn’t use for atopic dermati-tis. With every child that I treat with psoriasis I discuss the importance of keeping the skin hydrated with a good emollient to prevent trauma and fric-tion which prompts spread of disease via koebnerization.

If there’s overlap, I think the more complicated conversation to have with parents is explaining the natural his-tory of two diseases. Sometimes it is difficult to get parents to understand the reason that I can’t be specific right away and the possibility of an evolv-ing treatment plan. That can be tricky when you are trying to earn parent’s trust as a clinician.

DR. SIEGFRIED: Do you use topical corticosteroid

monotherapy for kids who present with mostly

psoriasis or exclusively psoriasis?

A Dr. Cordoro: Yes. Topical steroids are absolutely the leading treat-

ment for psoriasis and atopic dermati-tis. I start with a higher potency first. I don’t start low and build up. I try to get the child clear or near clear first and then titrate the potency depending on the extent, distribution and severity. Then I introduce more options, such as vitamin D analog on the weekends, or doing a vitamin D analog in the morn-ing and the evening, or maybe intro-ducing a topical calcineurin inhibitor.

DR. SIEGFRIED: How do you feel about patch testing

children?

A Dr. Cordoro: I think it’s fraught with problems, it’s hard to get enough sur- TAKEAWAY see page 46

and they just absolutely do not want to consider their use. These are the ones that need to hear simply that these approaches are the gold standard and widely accepted by Western-trained dermatologists and that we vet these therapies through data analysis and expert consensus.

It helps when I talk to patients about the fact that these medications have been formalized in the therapeutic guidelines by the American Academy of Dermatology.

I have written about this for parents and families because it’s such an issue.2

I often print this article and hand par-ents a copy. I also tell parents that I am more concerned that they won’t use these topical agents than I am that they will. For the right parent, that resonates. I adopted that approach from Ilona Frieden, and it is very effective.

The message is that the parent has a child with this difficult skin condition who is missing school, miserable, has dropping grades, the parents are miss-ing work, they are regularly cleaning bloody sheets; so what is the rationale to withhold the medication? There is a risk of untreated disease that outweighs the risks of treatment, and that’s what I try to communicate.

DR. SIEGFRIED: Do you have any sound bites for

black box topical calcineurin inhibitor phobia?

A Dr. Cordoro: I always tell patients that there is a black box warn-

ing and I describe exactly what the truth is in lay terms: The medication was fed to primates in high quanti-ties of active ingredient, some of the primates developed lymphomas. I mention that the warning is based on a theoretical risk and the data derives from nonhuman subjects. I mention that we’re making efforts to get this black box warning overturned. And I give the patient the choice. DT

tient anywhere from $10-$25, which is the price of the commercially available brand. Compounding is becoming a lost art really.

I think one of the other tricks to deal-ing with these formulary restrictions is to ask patients to compound simple things by themselves. I will often have a patient add a tube of a topical steroid into plain white petrolatum, or another emollient, to create something that will last them a bit longer, give them a little anti-inflammatory action while repair-ing the barrier.

Formulary problems are also difficult with systemic medications. If there is a systemic medication to be prescribed and I don’t believe there is an adequate substitute, I will call the carrier person-ally to provide the medical rationale and seek approval for its use.

Sadly this has become just a routine practice for so many prescriptions. Even now, generics require prior au-thorization for medications that we used to just prescribe liberally.

DR. SIEGFRIED: Yes. The amount of time that it takes

us to get kids access to medication is increasing

— particularly for the topical calcineurin inhibi-

tors. Having a generic alternative helps, but there

are increasing requirements for step edits and

prior authorization.

A Dr. Cordoro: I think something that is profoundly informative is looking

at the patient-visit-to-telephone-call ratio. So for the ones who call a lot, we are starting to see with a lot of different medications that, for example, we have one patient visit for atopic dermatitis and nine to 12 phone calls about autho-rization issues and pharmacy issues. We have not done this formally, but this was just an observation we have re-cently been making.

Where do we draw the line between our ability to give excellent care and the lack of ability for the patients to get the medications, and then the staff time and money wasted and time wasted to get the medicines. It’s just becoming so complex and problematic.

I think we need this kind of data to show companies and carriers that it is ridiculous when physicians are spend-ing this type of time on these kinds of problems.

DR. SIEGFRIED: What about for kids less than two

years old, for example, who need a steroid-spar-

ing agent and they can’t get a topical calcineurin

inhibitor, what do you do?

A Dr. Cordoro: I used to have no prob-lem prescribing and fighting for prior

authorization, but when the Food and Drug Administration put the black box warning on the topical calcineurin in-hibitors, it just gave us all pause. Even though many of us don’t believe it’s medically valid and it was based on a theoretical risk, carriers use that to their advantage to refuse the medication.

I call sometimes, but we have been very unsuccessful at getting this medi-cation for kids younger than two. We’re unsuccessful in getting topical calci-neurin inhibitors. Oftentimes, I lower the potency of the topical steroid or try to find an alternative like tar. Tar is a big workhorse in my clinic for both psoria-sis, atopic dermatitis and even sebor-rhea. Small amounts, for example, of liquor carbonis detergens (LCD) 3% or so mixed in petrolatum. There have been wonderful studies done about tar for clinical use in dermatology out of the Mayo Clinic. Their 25-year long-term follow-up study1 showed no increased risk of cutaneous carcinoma with tar combined with UV light, so I think the data and efforts like that helped Califor-nia to keep tar as a therapeutic option.

DR. SIEGFRIED: How do you handle steroid phobia?

A Dr. Cordoro: My approach has evolved over the years and varies

from patient to patient and family to family. I consider the overall context of the condition and what the parents are telling me. I try to read into what their motivations are and what their beliefs are. I think there are probably two main types of families that I see: There are parents who have been misinformed. They want detailed explanations of pathophysiology of atopic dermatitis, the history of steroids, and the mecha-nism of action of topical steroids or topi-cal calcineurin inhibitors. Once they understand the mechanism and the rationale for the use, they’re fine with using these therapies.

The second type of family I see consists of parents that have a fixed false belief about these medications

®

TAKEAWAYTHE46

JULY 2015 ⁄ DERMATOLOGYTIMES.COM

TAKEAWAY:Clinical pearls in pediatric dermatology from page 45

Next month: In August, Dr. Cordoro will

continue this discussion, addressing

triggers and systemic treatments.

See references at:

bit.ly/Clinicalpearlspedederms

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Contact Karey, (866) 488-4100 or

www.MyDermGroup.com

Busy Derm office seeking PT Dermatologist

t Job available immediately

t Stable long term position

t Salary negotiable

Please email resume to bettybellman@yahoo.com

START A NEW PRACTICE IN MIAMI BEACH!

NATIONAL

Repeating an ad ENSURES

it will be seen

and remembered!CLASSIFIED WORKS!

MarketplaceJuly 2015 | DermatologyTimes.com

51

CAREERS

NORTH CAROLINA

NEW YORK

OKLAHOMANEW MEXICO

HICKORY, NC

Partnership available. Established practice.

Contact Karey, (866) 488-4100 or

www.MyDermGroup.com

SANFORD, NC

Partnership available. Established practice.

Contact Karey, (866) 488-4100 or

www.MyDermGroup.com

SANTA FE, NEW MEXICO

Partnership available. Established practice.

Contact Karey, (866) 488-4100 or

www.MyDermGroup.com

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)1%-0�':��()612=1$KQEMP�GSQ

&632<��1%2,%88%2��2='7))/-2+�794)6:-7-2+�()61%8303+-78

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[MXL�PMQMXIH�TEXMIRX�GEVI�VIWTSRWMFMPMXMIW��,MKLP]�GSQTIXMXMZI�GSQTIRWEXMSR�

The Skin Cancer Center at the Tulsa

Cancer Institute is seeking a Board

Certified/Eligible Dermatologist to add

to its practice of cutaneous oncology.

Expertise and interest in melanoma

and Mohs surgery required.

The Tulsa Cancer Institute is the largest

physician-owned oncology network in

the state offering services at five cancer

centers throughout Oklahoma with

board certified physicians specializing in

Medical Oncology, Radiation Oncology,

Gyn-Oncology, and Dermatology/

Mohs Surgery.

Excellent opportunity to join a patient

centered practice in a collegial clinical

atmosphere with academic and

research opportunities as well as

housed in a state of the art facility.

Benefits include base salary guarantee

with production bonus, health insurance,

vacation/CME and the opportunity for

partnership in 2 years.

For further information contact:

Edward H. Yob, DO at

edward.yob@tciok.org or

call 918-307-0215

Tulsa, Oklahoma

MASSACHUSETTS

Large, multispecialty practice located in North Dartmouth, MA is a seeking

to add another BC/BE dermatologist. One year to full partnership. Current

dermatologist earning $450K+ working three days per week doing only

medical and surgical dermatology.

Coastal Massachusetts

D E R M A T O L O G I S T

Interested candidates email to: kmcginnis@hawthornmed.com

CLASSIFIED WORKS!

Recruitment Advertising

Can Work For You!

RECRUITMENT

ADVERTISING

Call Joanna Shippoli

to place your

Recruitment ad

at 800.225.4569

ext. 2615

jshippoli@advanstar.com

RECRUITMENT

ADVERTISING

Can Work For You!

Reach highly-targeted,

market-specific business

professionals, industry

experts and prospects by

placing your ad here!

Marketplace52 Dermatology Times | July 2015

CAREERS

FREDERICKSBURG, VIRGINIAPartnership available. Established practice.

Contact Karey, (866) 488-4100 or www.MyDermGroup.com

BOUNTIFUL, UTAHAssociate to Partner Opportunity.

Established practice. Contact Karey, (866) 488-4100 or

www.MyDermGroup.com

UTAH

VIRGINIA

OREGON

WASHINGTON

EUGENE, OREGONPart Time/Full Time PositionGeneral/Cosmetic/Surgical

DermatologySpectacular Scenic Beauty

Excellent BenefitsFax CV & Cover Letter to

541-683-5206 Or Call 541-681-5090

SEATTLE AREA

Hospital employed joining 1 Dermatologist

1 Mohs Surgeon and 2 PA’s in desirable growing

family oriented community on the Puget Sound

45 minutes to downtown Seattle associated with

new 137 bed hospital with all private rooms.

Optional Cosmetics. 4 day work week. $435K

salary, signing/production bonus, benefits and

relocation.

800-831-5475donohueandassoc@aol.com

TEXAS

Premier Dermatology Practice

BC/BE Dermatologist PT/FT

Established Practice – 40 Yrs.

Excellent Benefits & Growth Potential

Medical, Surgical, Cosmetic

Mohs Surgery

Send Cover Letter and CV to:

tlwd47@suddenlinkmail.com

Contact (214) 862-0017

EAST TEXAS

WASHINGTON

Physician - DermatologyVirginia Mason in Seattle, WA has exceptional opportunities for Dermatologists at its downtown Seattle medical center and at its regional medical centers in Bellevue and Bainbridge Island, WA. The dermatologists have the opportunity to develop their preferred mix of general dermatology and cosmetics. The Dermatology group has a strong reputation and the patient volumes are high. You will be busy on day one. Enjoy working in a multi-specialty setting with excellent dermatopathology and Mohs support, and easy access to other superb physicians. Our dermatologists choose to work four 10-hour days and one of these days is spent at the downtown clinic. This strengthens the communication among the members of the team and also provides wonderful work/life balance.

Our ideal candidate is BC/BE in Dermatology. Strong preference for physicians who enjoy teaching and working in a team environment, and are patient-focused and enjoy participating in a culture of process improvement to enhance the patient experience and transform healthcare.

Join our innovative integrated Health Care Team. We off er a competitive salary and comprehensive benefi t package. There is an income guarantee for the fi rst two years, with potential for an increase after one year. In the third year there is a conversion to a wRVU model rewarding productivity and patient satisfaction.

For more information or to apply, send CV to: Kelly Pedrini, Physician Recruiter at kelly.pedrini@virginiamason.org; (206) 341-1232. EOE.

Recruitment

Advertising

Can Work For You!

This index is provided as an additional service. The publisher does not assume any liability for errors or omissions.

ADVERTISER PRODUCT WEBSITE PAGE

AMGEN CORPORATE www.biotechnologybyamgen.com 5

BAYER HEALTHCARE PHARMACEUTICALS FINACEA www.finacea.com 9

CANFIELD SCIENTIFIC VEOS www.canfieldscientific.com 41

GALDERMA LABORATORIES EPIDUO www.epiduo.com COVERTIP

GALDERMA LABORATORIES EPIDUO www.epiduo.com CV2

GALDERMA LABORATORIES SOOLANTRA www.soolantra.com 15 - 16

JOHNSON AND JOHNSON PRODUCTS AVEENO www.aveeno.com 7

MEDICAL TECHNOLOGY INDUSTRIES www.mti.net 25

MICROFOUR INC www.practicestudio.net 29

NEOSTRATA CO SKIN ACTIVE www.neostratapro.com 27

OBAGI MEDICAL PRODUCTS CORPORATE www.obagi.com CV4

PACIFIC WORLD BIO-OIL www.bio-oilusa.com 35

SENSUS HEALTHCARE www.sensushealthcare.com 13

SUNEVA MEDICAL BELLAFILL www.bellafill.com CV3

VALEANT PHARMACEUTICALS INTL CERAVE www.valeant.com 11

VALEANT PHARMACEUTICALS INTL RETIN-A MICRO www.valeant.com 31 - 32

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