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A PEER-REVIEWED JOURNAL PROVIDING EVIDENCE-BASED INFORMATION TO PRACTICING CLINICIANS

a Peer-reViewed JourNal

Vol. 8, No. 1 JaNuary 2015

www.jcadonline.com

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Atrophic Acne Scarring: A Review of Treatment Options

Efficacy, Safety, and Subject Satisfaction of a Specified Skin CareRegimen to Cleanse, Medicate, Moisturize, and Protect the Skin of

Patients Under Treatment for Acne Vulgaris

Comparative Efficacy and Tolerability of Dapsone 5% in Adult Versus Adolescent Females with Acne Vulgaris

Calcium Hydroxylapatite: Over a Decade of Clinical Experience

Papular Scars:

An Addition to the Acne Scar Classification Scheme

PLUS: Special American Acne and Rosacea Society Update

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EDITOR-IN-CHIEF, CLINICAL DERMATOLOGY James Q. Del Rosso, DO, FAOCD

Dermatology Residency Director

Valley Hospital Medical Center

Las Vegas, Nevada

EDITOR-IN-CHIEF, AESTHETIC DERMATOLOGY W. Philip Werschler, MD, FAAD, FAACS

Assistant Clinical Professor of

Medicine/Dermatology

University of Washington School of Medicine

Seattle, Washington

1595 Paoli Pike Suite 201 West Chester, PA 19380

PRESIDENT

Robert L. Dougherty

(484) 266-0702

[email protected]

PARTNER

Patrick D. Scullin

(484) 266-0702

[email protected]

VICE PRESIDENT, PUBLISHER

Joseph J. Morris

(484) 266-0702

[email protected]

VICE PRESIDENT

Elizabeth A. Klumpp

(484) 266-0702

[email protected]

EXECUTIVE EDITOR

Kimberly B. Chesky

(484) 266-0702

[email protected]

ASSOCIATE EDITOR

Angela M. Hayes

(484) 266-0702

[email protected]

The official journal of American Acne & Rosacea Society

Inde

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on

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entral

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The Journal of Clinical and AestheticDermatology is indexed in the followingreference sources:

PubMed CentralCINAHLEMBASEScopus

[ J a n u a r y 2 0 1 5 V o l u m e 8 N u m b e r 1 ]6

EDITORIAL ADVISORY BOARD

EDITORIAL ADVISORY BOARD

EDITOR-IN-CHIEF,

CLINICAL DERMATOLOGY

James Q. Del Rosso, DO,

FAOCD

Dermatology Residency

Director, Valley Hospital

Medical Center

Las Vegas, Nevada

EDITOR-IN-CHIEF,

AESTHETIC DERMATOLOGY

W. Philip Werschler, MD,

FAAD, FAACS

Assistant Clinical Professor

of Medicine/Dermatology

University of Washington

School of Medicine

Seattle, Washington

BUSINESS STAFF

PRESIDENT

Robert L. Dougherty

PARTNER

Patrick D. Scullin

VICE PRESIDENT/ PUBLISHER

Joseph J. Morris

VICE PRESIDENT

Elizabeth A. Klumpp

EXECUTIVE EDITOR

Kimberly B. Chesky

ASSOCIATE EDITOR

Angela M. Hayes

Andrew F. Alexis, MD

New York, NY

Mark A. Bechtel, MD

Columbus, OH

Kenneth R. Beer, MD

West Palm Beach, FL

Brian Berman, MD, PhD

Miami, FL

Diane S. Berson, MD

New York, NY

Sanjay Bhambri, DO

Frisco, TX

Neal D. Bhatia, MD

San Diego, CA

Elizabeth M. Billingsley, MD

Hershey, PA

Kathryn Boyse Gant, MD

Columbus, OH

Whitney Bowe, MD

New York, NY

Robert L. Buka, MD, JD

New York, NY

Valerie Callender, MD

Glenn Dale, MD

Jennifer C. Cather, MD

Dallas, TX

Roger I. Ceilley, MD

Iowa City, IA

Lloyd J. Cleaver, DO

Kirksville, MO

Joel L. Cohen, MD

Englewood, CO

Philip R. Cohen, MD

Bellaire, TX

Seemal R. Desai, MD

Plano, TX

Chrie M. Ditre, MD

Philadelphia, PA

Zoe D. Draelos, MD

High Point, NC

Joseph S. Eastern, MD

Belleville, NJ

Lawrence Eichenfield, MD

San Diego, CA

Patricia K. Farris, MD

Metairie, LA

Amy Forman Taub, MD

Lincolnshire, IL

Richard G. Fried, MD, PhD

Yardley, PA

Jorge G.-Zuazaga, MD, MBA

Cleveland, OH

Dee Anna Glaser, MD

St. Louis, MO

Brad P. Glick, DO

Miami, FL

Michael H. Gold, MD

Nashville, TN

Gary Goldenberg, MD

New York, NY

Lawrence J. Green, MD

Rockville, MD

Steven K. Grekin, DO

Bloomfield Hills, MI

Pearl E. Grimes, MD

Los Angeles, CA

Adelaide A. Hebert, MD

Houston, TX

Warren Heymann, MD

Marlton, NJ

Firas George Hougeir, MD

Atlanta, GA

Shasa Hu, MD

Miami, FL

Jeffrey P. Hurley, MD

West Chester, PA

Sherrif F. Ibrahim, MD, PhD

Rochester, NY

Mark D. Kaufmann, MD

New York, NY

Jonette E. Keri, MD, PhD

Miami, FL

Grace K. Kim, DO

Las Vegas, NV

Susun Kim, DO

Las Vegas, NV

William Kirby, DO

Beverly Hills, CA

Leon H. Kircik, MD

Louisville, KY

Robert Kirsner, MD

Miami, FL

Andrew C. Krakowski, MD

San Diego, CA

Mark A. Kuriata, DO

Saint Joseph, MI

Mark G. Lebwohl, MD

New York, NY

Jacquelyn Levin, DO

Largo, FL

Mary P. Lupo, MD

New Orleans, LA

Ellen Marmur, MD

New York, NY

George Martin, MD

Kihei, HI

Morgan McCarty, DO

Georgetown, TX

Amy J. McMichael, MD

Winston Salem, NC

Brent Michaels, DO

Las Vegas, NV

Saira Momin, DO

Dallas, TX

Gary D. Monheit, MD

Birmingham, AL

Samuel L. Moschella, MD

Boston, MA

Christen M. Mowad, MD

Danville, PA

Mark S. Nestor, MD, PhD

Miami, FL

Khanh Nguyen, MD

Houston, TX

Edit Olasz, MD, PhD

Houston, TX

Carmelo A. Plateroti, DO

Templeton, CA

Albert E. Rivera, DO

Madison, AL

Edward F. Ryan, DO

Philadelphia, PA

Joel Schlessinger, MD

Omaha, NE

Sejal K. Shah, MD

New York, NY

Ava T. Shamban, MD

Santa Monica, CA

Kanade Shinkai, MD, PhD

San Francisco, CA

Candace T. Spann, MD

Las Vegas, NV

James M. Spencer, MD, MS

St. Petersburg, FL

Linda Stein-Gold, MD

Detroit, MI

Howard K. Steinman, MD

Temple, TX

Jeffrey M. Suchniak, MD

Rocky Mount, NC

Abel Torres, MD

Loma Linda, CA

Antonella Tosti, MD

Miami, FL

Stephen K. Tyring, MD, PhD

Houston, ,TX

Janet Vafaie, MD

Los Angeles, CA

Guy F. Webster, MD, PhD

Hockessin, DE

Jeffrey M. Weinberg, MD

New York, NY

Susan H. Weinkle, MD

Bradenton, FL

Joshua A. Zeichner, MD

New York, NY

John A. Zic, MD

Nashville, TN

Matthew J. Zirwas, MD

Columbus, OH

Terry Arnold, PA

Tulsa, OK

Richard Brandt, PA-C, MPAS

Arlington, TX

Joseph Alcalay, MD

Tel Aviv, Israel

Koenraad De Boulle, MD

Aalst, Belgium

Aditya K. Gupta, MD

London, Ontario, Canada

Marina Landau, MD

Herzlia Pituach, Israel

Moshe Lapidoth, MD

Petah Tikva, Israel

Leonardo Marini, MD

Trieste, Italy

Bianca Maria Piraccini, MD

Bologna, Italy

Jean Revuz, MD

Paris, France

Marco Romanelli, MD, PhD

Pisa, Italy

Luigi Rusciani, MD

Rome, Italy

M. Emily Piansay-Soriano, MD

Philippines

Antonio Picoto, MD

Portugal

Gerhard Satler, MD

Germany

Jerry K. L. Tan, MD

Windsor, Ontario, Canada

U S B O A R D M E M B E R S

I N T E R N A T I O N A L B O A R D M E M B E R S

IN THIS ISSUE

I N T H I S I S S U E

Vol . 8 , No. 1 January 2015

19

57

38

38

Editorial Message......................................................................................................................10

American Acne and Rosacea Society Update...........................................................................14

LETTER TO THE EDITORPapular Scars: An Addition to the Acne Scar Classification Scheme .................................19Stephanie D. Gan, MD; Emmy M. Graber, MD, MBA

ORIGINAL RESEARCHEfficacy, Safety, and Subject Satisfaction of a Specified Skin Care Regimento Cleanse, Medicate, Moisturize, and Protect the Skin of Patients UnderTreatment for Acne Vulgaris....................................................................................................22James Q. Del Rosso, DO, FAOCD; Michael Gold, MD, PhD; Maria Jos Rueda, MD; Staci Brandt, PA-C; Warren J. Winkelman, MD, PhD

ORIGINAL RESEARCHComparative Efficacy and Tolerability of Dapsone 5% in Adult Versus Adolescent Females with Acne Vulgaris .................................................................................31James Q. Del Rosso, DO; Leon Kircik, MD; Conor J. Gallagher, PhD

REVIEWCalcium Hydroxylapatite: Over a Decade of Clinical Experience .......................................38Jani van Loghem, MD; Yana Alexandrovna Yutskovskaya, MD; Wm. Philip Werschler, MD

LITERATURE REVIEWAtrophic Acne Scarring: A Review of Treatment Options....................................................50Meghan T. Hession, MD; Emmy M. Graber, MD, MBA

Promius is pleased to sponsor digital publishing for

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Special IssueCommon Facia l Dermatoses

2014 Bayer HealthCare Pharmaceuticals Inc. Bayer, the Bayer Cross, Finacea and the Finacea logo are registered trademarks of Bayer. All rights reserved. PP-825-US-0202 | September 2014

Prescribe

Finacea

rst


It is with great pleasure and pride

that I introduce to you this special

issue of JCAD focusing on facial

dermatoses to start off 2015. This

issue emphasizes both acne and

facial aesthetics. Acne scarring is

addressed in the literature review by

Hession and Graber on atrophic acne

scarring. This is a very common

problem encountered in clinical

practice that occurs even in some

patients without severe nodular

acne. This thorough article should

assist the clinician in both the

assessment and management of

atrophic acne scars and provide

guidance regarding reasonable

expectations associated with

different treatment approaches. In a

letter to the editor, papular acne

scars are discussed by Gan and

Graber, and the concept of adding

this category to the classification of

acne scars is addressed.

The concept of proper skin care as

a component of the management of

acne has received greater attention

over the past few years. Maintaining

the integrity of the epidermal barrier

can reduce both skin irritation and

inflammation related to increased

transepidermal water loss. Del Rosso,

Gold, Rueda, Brandt, and Winkelman

review the use of a specific skin care

regimen that incorporates a facial

cleanser and moisturizer with SPF 30

sunscreen formulated for use on

acne-prone and acne-affected skin.

This skin care regimen was evaluated

in combination with adapalene

0.1%/benzoyl peroxide 2.5% gel once

daily, demonstrating the positive

attributes of this complete acne

management approach.

In another article, Del Rosso,

Kircik, and Gallagher review a

comparison of therapeutic outcomes

in adolescent females versus adult

women with acne treated with

dapsone 5% gel twice daily for acne.

The results demonstrate efficacy and

safety in both subsets consistent with

what has been reported in Phase 3

pivotal trials, with some suggestion

based on the data of possible greater

efficacy in the adult female

population.

The final article relates to facial

aesthetics. In this article, a decade of

experience with calcium

hydroxylapatite is thoroughly

reviewed by Loghem, Yutskovskaya,

and Werschler, which should be

helpful to clinicians practicing

cosmetic dermatology.

Please be sure to also read the

update from The American Acne and

Rosacea Society (AARS), as there are

new and exciting projects emerging

from that society. I encourage you to

join the AARS if you have not yet

become a member.

Stay happy and healthy. I hope

you enjoy this issue of JCAD.

James Q. Del Rosso, DO

Editor-in-Chief,

Clinical Dermatology, JCAD

EDITORIAL MESSAGE

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

Special Focus: Facial Dermatoses

James Q. Del Rosso, DO, FAOCDEditor-in-Chief, Clinical DermatologyThe Journal of Clinical and AestheticDermatology

[ J a n u a r y 2 0 1 5 V o l u m e 8 N u m b e r 1 ] 111111111111111111

INFORMATION FOR AUTHORS


Submission requirements for The Journal of Clinical and

Aesthetic Dermatology are in accordance with the

International Committee of Medical Journal Editors

(ICMJE). See Uniform Requirements for Manuscripts

Submitted to Biomedical Journals at www.icmje.org.

EDITORIAL PURPOSE

The mission of The Journal of Clinical and

Aesthetic Dermatology (JCAD) is to provide

dermatologists with up-to-date, evidence-based

information on the latest treatment options, new

techniques, and practice management issues; thus,

helping them improve their daily practice. JCAD is a peer-

reviewed medical journal that publishes original research

and practical information on a broad range of pertinent

topics relating to both clinical and aesthetic dermatology.

SCOPE OF MANUSCRIPTS

Manuscripts that meet our editorial purpose include

but are not limited to: (1) reports of preclinical and

clinical research studies that expand existing knowledge;

(2) case studies and reports that stimulate research and

the exchange of information; (3) in-depth reviews of

clinical practice, management, reimbursement,

education, ethics, and legal issues; (4) reviews and

reports of contemporary topics in dermatology and

dermatology practice that may affect the delivery,

reimbursement, or practice of dermatologic care.

Original Research. Reports of investigations

that address questions about clinical care or expand

existing knowledge. References and illustrative

material are recommended. Must include abstract.

Recommended length: up to 6000 words, not

including references.

Review Articles. Comprehensive articles

summarizing basic strategies to facilitate the

dermatologists approach to diagnosis and treatment and

articles highlighting emerging diagnostic and therapeutic

modalities. May also include in-depth reviews of clinical

practice, management, reimbursement, educational,

ethical, and legal issues. At least 25 current references

are recommended. Illustrative material is preferred. Must

include abstract. Recommended length: up to 6000

words, not including references.

Case Reports. Short presentations of actual

cases that stimulate research and the exchange of

information and illustrate the signs and symptoms,

diagnosis, and treatment of a disorder. At least 15

current references are recommended. Illustrative

material is preferred. Must include abstract.

Recommended length: 1000 to 3000 words (not

including references).

Brief Reports. Short reports of original studies

or evaluations or unique, first-time reports of clinical

case series. Must include abstract. Recommended

length: 1000 to 1500 words (not including

references).

Special Communications. Communications that

describe an important issue in clinical or aesthetic

dermatology in a scholarly, thorough, well-referenced,

systematic, or evidence-based manner. Must include

abstract. Recommended length: up to 3000 words

(not including references).

Commentaries. Essays that address important

topics in clinical or aesthetic dermatology and

generally are not linked to a specific article.

Commentaries should be well focused, scholarly, and

clearly presented. Include approximately 20

references. Recommended length: 1500 to 2000 words.

Letters to the Editor. Opinions on cases or

articles published in The Journal of Clinical and

Aesthetic Dermatology, opinions on other current

topics, or short reports of clinical interest. Must be

concise and to the point. Please indicate whether the

letter is intended for publication. Text should not

exceed 600 words, with no more than five references.

Letters should be received within 2 months of the

articles publication and may be sent to the original

author for reply. The editor reserves the right to edit

the material for style, clarity, and size.

MANUSCRIPT SUBMISSION

Submissions for consideration may be sent

electronically to: Kim Chesky, Managing Editor,

[email protected]. Hard copy submissions

are no longer accepted.

Cover Letter. Manuscripts should be submitted

with a cover letter indicating the article type. The

cover letter should give details on any previous or

duplicate publication of any of the content and should

state that the paper is not under consideration for

publication elsewhere. In the cover letter, authors

should disclose any potential financial conflicts of

interest relevant to the submitted manuscript. For

Letters to the Editor, please indicate whether the

letter is intended for publication.

Conflict of Interest Disclosures. All authors

should disclose any potential financial conflicts of

interest relevant to the submitted manuscript in the

cover letter of the submitted manuscript.

Informed Consent. Informed consent should be

obtained if there is any doubt that anonymity can be

maintained. Patient consent should be written and

archived either with the journal, the authors, or

both, as dictated by local regulations or laws. See

www.icmje.org for more information.

Author and Copyright Forms. Upon

submission, authors will be asked to complete and

return an Author Form, which requires corresponding

author information, authorship statement, and

financial disclosure. Authors will also be asked to sign

and return a copyright form. If the manuscript is

accepted and published in The Journal of Clinical

and Aesthetic Dermatology, authors must transfer

copyright to Matrix Medical Communications.

Registration of Clinical Trials. As

recommended by the ICMJE, The Journal of

Clinical and Aesthetic Dermatology requires, as a

condition of consideration for publication, registration

of all clinical trials in a public trials registry that

requires the minimum registration data set as

determined by the ICMJE [visit http://www.icmje.org/

index.html#clin_trials for guidelines]. Please include

the trial registry name, registration number, and the

url for the registry in the abstract.

Inclusion of previously published materials.

Any material submitted to The Journal of Clinical

and Aesthetic Dermatology that is reproduced from

previously published copyrighted material must be

accompanied by a letter of permission from the

copyright holder. All such material should include a

full credit line (e.g., in the figure or table legend)

acknowledging the original source. The author is

responsible for obtaining the permission and is

responsible for any associated fees.

MANUSCRIPT PREPARATION

Title Page. The title page should contain the

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on

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following elements: title, author names and

institutional affiliations, sources of financial support,

name of corresponding author with his or her complete

contact information (mailing address, telephone and

fax numbers, e-mail address), and word count.

Spacing and Pagination. Please use double

spacing throughout. Do not use a running head. Pages

should be numbered beginning with the title page.

Please line number all submissions for the benefit of

our reviewers. To add line numbers to your Word file,

select View/Print Layout/Format/Document/select

Layout Tab/select Line Numbers/check Add Line

Numbering and Continuous, and save the changes.

Abstract. Include a structured abstract with all

articles, except letters to the editors. Abstracts should

be limited to 250 words and should be organized into

the following categories: Objective, Design, Setting,

Participants, Measurements, Results, Conclusion.

Abstracts of clinical trials must include trial registry

information (registry name, registration number, and

url for the registry).

Keywords. Include all relevant keywords

following the abstract.

Abbreviations/Acronyms. All abbreviations and

acronyms should be spelled out at first mention.

References. Citation accuracy is the

responsibility of the author. Requirements are in

accordance with the Uniform Requirements for

Manuscripts Submitted to Biomedical Journals

(see www.icmje.org for more information). References

must be cited in text in numerical order and must

appear as a complete list at the end of the manuscript.

(See Uniform Requirements.) Do not superscript

reference numbers in the text; place the numbers at

the end of the corresponding sentences or paragraphs

between brackets. Abbreviate names of journals

according to Index Medicus style. Book references

should include the author(s), editor(s), title, edition

number, publisher and city, copyright date, volume,

and specific page numbers for quoted material.

The sequence for a journal article should be:

authors (up to four; for five or more authors, list the

first three, followed by et al), title of paper, journal

name abbreviated as in the Index Medicus, year of

publication, volume number, issue number and first

and last page numbers. Example:

1. Del Rosso JQ, Webster GF, Jackson M, et al. Two

randomized phase III clinical trials evaluating

anti-inflammatory-dose doxycycline (40-mg

doxycycline, USP capsules) administered once

daily for treatment of rosacea. J Am Acad

Dermatol. 2007;56(5):791802.

The sequence for chapters of a book should be:

author(s), chapter title, editors, book title, edition,

place of publication, publisher, year, page

numbers. Example:

2. Hanake E, Baran R, Bureau H. Tumors of the nail

apparatus and adjacent tissues. In: Baran R,

Dawber RPR, de Berker DAR, et al, eds. Baran

and Dawbers Diseases of the Nails and Their

Management. 3rd ed. Malden, Mass: Blackwell

Science; 2001:515630.

The sequence for conference proceedings is:

3. Heller T. Promoting healthy aging and community

inclusion of adults with developmental disabilities.

Presented at: The National Association for the

Dually Diagnosed; October 24, 2003; Chicago.

Authors are responsible for ensuring that the list

contains all references cited in the text, in order,

accurately.

Tables and Figures. All illustrative material must

be numbered consecutively according to citation in

text. If a figure or table has been previously published,

the complete reference information must be cited, and

written permission from the publisher to reproduce

must be submitted with the material. Obtaining

permission (and any associated fees) to include

previously published materials in a JCAD

submission is the responsibility of the author.

Photographic illustrations may be submitted as color or

black-and-white electronic .jpg or .tif files (min. 300

dpi). Other types of illustrations (e.g., drawings,

graphs, charts) must be professionally executed and

also submitted electronically. Symbols and

abbreviations should be defined/spelled out. For black-

and-white or color photographs, the required

resolution is at least 300 dpi. For line drawings, the

resolution must be at least 600 dpi.

EDITORIAL PROCESS

Peer Review. All submissions undergo peer

review to ensure that the material is clinically relevant

and concise. A minimum of two reviewers will assess

each submission. Strict confidentiality regarding the

submitted manuscript is maintained. Based on the

reviewers/editors comments, manuscripts may be

accepted, rejected, or recommended for revision.

Reviewers comments that are considered constructive

will be shared with the author.

Editing and Page Proofs. Articles accepted for

publication will be edited for consistency of style, clarity,

and correct grammatical construction. Page proofs will

be sent to the author prior to publication for approval

and may contain author queries that will need to be

addressed. The author will be given no more than

48 hours to respond with changes/corrections. The

author is responsible for all changes in the manuscript,

including those of the copy editor.

REPRINTS AND COMPLIMENTARY COPIES

All authors receive five complimentary copies of the

issue in which their article appears. Article reprints

are available at a discounted price to the

corresponding author. Reprint pricing will be provided

to the corresponding author along with issue copies

following publication. Orders must be for a minimum

of 100 copies. Contact Kim Chesky for details at

[email protected].

MANUSCRIPT CHECKLIST

Original manuscript (double-spaced)

Cover letter affirming the manuscripts originality

and stating any financial disclosures

Corresponding author's name, address, phone

number, fax number, and e-mail address on the

title page

References cited in consecutive order in text and

conformed to Uniform Requirements style

Black-and-white or color figures supplied as

electronic .jpg or .tif files with a minimum 300 dpi

Professionally executed drawings, algorithms,

graphs, charts, etc, with all symbols and

abbreviation/ acronyms defined and supplied as

electronic .jpg or .tif files with a minimum 300 dpi

Copies of permission letters to reproduce

previously published and unpublished material.

Send submissions to:

Kim Chesky, Executive Editor

Matrix Medical Communications

Phone: (866) 325-9907 (toll-free) or (610) 325-9905

Fax: (610) 325-9906

[email protected]

www.jcadonline.com


14 [ J a n u a r y 2 0 1 5 V o l u m e 8 N u m b e r 1 ]

On September 6, 2014, the third

meeting of the Scientific Panel on

Antibiotic Use in Dermatology

(SPAUD) took place in Las Vegas,

Nevada. SPAUD, founded in 2005 by

James Q. Del Rosso, DO, held its

first meeting in April 2006 and its

second meeting in November 2007.

In addition to Dr. Del Rosso, the

SPAUD members involved in the first

two meetings were Drs. James

Leyden, Guy Webster, Dirk Elston,

Diane Thiboutot, and Jan

Hirschmann. These first two

meetings were both followed by

published supplements in Cutis in

2007 and 2008, along with articles

published in Dermatologic Clinics in

2009, and scientific poster

presentations at several major

medical meetings.13 These

publications addressed patterns of

antibiotic use in dermatology,

bacterial resistance issues, antibiotic

use in acne and rosacea,

management of methicillin-resistant

Staphylococcus aureus (MRSA) and

nasal staphylococcal carriage,

prophylactic and perioperative

antibiotic use, and when antibiotics

are not needed.

The faculty for the latest SPAUD

meeting comprised AARS President

Dr. Lawrence Eichenfield, Drs. James

Leyden, Guy Webster, Diane

Thiboutot, Theodore Rosen, Richard

Gallo, Clay Walker, James Del Rosso,

and Guillermo Sanchez, PA-C, MPH.

Mr. Sanchez participated on behalf of

the Centers for Disease Control and

Prevention (CDC). Through a media

partnership with the CDC annual

initiative titled Get Smart: Know

When Antibiotics Work, the AARS is

in a position to impact the level of

education in dermatology, and

increase research efforts in the areas

of antibiotic usage, resistance, and

prescribing patterns.

The SPAUD faculty gratefully

acknowledges Dr. George Zhanel, a

microbiologist and pharmacologist

from the University of Manitoba in

Canada and Director of the Canadian

Antimicrobial Resistance Alliance

(CARA). Dr. Zhanel was unable to

attend the September meeting in Las

Vegas due to a prior obligation;

however, he contributed significantly

to the meeting content and is actively

involved in the SPAUD project.

WHY WAS SPAUD ORIGINALLYFORMED?

Approximately a decade ago,

information about the emergence of

bacterial pathogens that no longer

responded to previously effective

antibiotics was heavily publicized in

the lay press and in the medical

literature in the United States. MRSA

infections, which have been seen in

hospitals since 1961, became a

common reason patients were

presenting to many medical offices

throughout the United States.

Patients with skin infections caused

by community-acquired MRSA were

encountered regularly in ambulatory

medical practices. This was very

alarming at the time, as clinicians

were both perplexed as to the origin

of these MRSA strains and

challenged by many of the cases that

presented as multiple abscesses or

recurrent MRSA skin infections.

Around the same time, the United

States media heavily emphasized

that no new classes of antibiotics

had been developed for more than

two decades and that certain

antibiotic-resistant pathogenic

bacteria had emerged, especially in

hospitals and other healthcare

facilities. To add, the US Food and

Drug Administration (FDA) mandated

that approved product labeling for all

antibiotics (except those specifically

used to treat tuberculosis) be

updated to stress the importance of

attempting to find the bacterial

pathogen in order to select antibiotic

therapy more effectively. In 1995, the

CDC launched the National

Campaign for Appropriate Antibiotic

AN UPDATE FROM AARS

THE AMERICAN ACNE & ROSACEA SOCIETY (AARS) HOSTS THE THIRD MEETING OFTHE SCIENTIFIC PANEL ON ANTIBIOTIC USE IN DERMATOLOGY (SPAUD)


Use in the Community. Over time,

several other initiatives related to

concerns about antibiotic resistance

have been formed both in the United

States and globally. These include

national and local programs on

Antibiotic Stewardship in the United

States and many other countries,

World Alliance Against Antibiotic

Resistance (WAAAR), the World

Health Organization (WHO) Initiative,

European Antibiotic Awareness Day,

and Oregon AWARE (Alliance

Working for Antibiotic Resistance

Education). In 2003, the CDC

changed its national campaign

program to Get Smart: Know When

Antibiotics Work, and have available

for clinicians several handout

materials for patient education.

A high noise level about antibiotic

resistance has persisted in the United

States and the paucity of new

antibiotics being developed is a

reality that continues to be a major

challenge. Nevertheless, there was a

conspicuous absence of discussion

about the relevance of antibiotic

resistance to dermatologic practice.

SPAUD was formed so that the

discipline of dermatology would

initiate its own scientific and practical

assessment of how antibiotics are

used in dermatology and suggest

approaches that mitigate the risk of

inducing resistant bacterial strains.

This was achieved by bringing

together a select group of

dermatologists with established

interest in the subject, infectious

disease specialists, and

microbiologists to discuss how oral

and topical antibiotics are used in

dermatology and to look closely at

issues related to antibiotic

prescribing patterns and the impact

of bacterial resistance. A natural

sequence to these discussions was

the development of recommendations

on optimal antibiotic prescribing and

avoidance of antibiotic use when it is

not needed.

IN WHAT WAYS DOES

ANTIBIOTIC PRESCRIBING BY

DERMATOLOGISTS DIFFER FROM

OTHER PHYSICIAN GROUPS?

One of the obvious major

differences between how

dermatologists commonly prescribe

antibiotics as compared to most

other clinicians is that most

antibiotic prescriptions in

dermatology are written for the

treatment of chronic inflammatory

skin disorders, such as acne

vulgaris (AV) and rosacea. These

disorders are not infectious in

etiology, and antibiotic therapy when

used is commonly administered

over several weeks to months.

Changes in the microbial flora and

antibiotic sensitivities of the skin,

anterior nares, and oropharynx

occur after use of oral antibiotic

therapy for disorders, such as AV

and rosacea.47 In addition,

dermatology practitioners

commonly prescribe topical

antibiotics (i.e., clindamycin,

erythromycin) over more prolonged

durations of therapy for AV, which

can alter the microbial composition

and antibiotic sensitivity of the

cutaneous and anterior nasal flora.47

The significance of SPAUD as an

active educational initiative under the

AARS is further supported by

prescription data from 2010 that

showed that 258 million courses of

oral antibiotics were prescribed,

which translates to 833 prescriptions

per 1,000 persons.8 Dermatologists

accounted for 8.2 million oral

antibiotic prescriptions, or three

percent of the total prescriptions

written. However, dermatologists

also accounted for the greatest

number of antibiotic prescriptions

per provider (724), followed by

family practice (667), and pediatrics

(598). Overall in 2010, among all US

physicians, prescription data showed

that azithromycin was the most

commonly prescribed oral antibiotic.

However, based on 2011

prescription data, approximately

three-fourths of all oral antibiotics

prescribed by dermatologists are for

ABOUT AARS

The AARS, founded in 2005 by practicing dermatologists, provides a forum for the exchange

of information about acne and rosacea as well as the promotion of research into these two skin

diseases. Visit our website at: www.acneandrosacea.org to see the programs and learn more.

tetracycline agents (doxycycline

[38%], minocycline [30%],

tetracycline [5%]).9

A complete publication based on

the information presented and

discussed at SPAUD is in progress.

The following are a few highlights

from the meeting.

The use of antibiotics in

livestock feed comprises almost

80 percent of total antibiotic

use in the United States.10

Antibiotic-resistant bacterial

strains as well as antibiotics

themselves gain access to

wastewater from livestock and

poultry farms.

The addition of antibiotics to

livestock feed may alter the

microbial ecology, can

contribute to emergence of

infections in humans, and can

increase carriage of resistant

bacteria. For example, 30

percent of workers employed at

farms using tetracycline in

animal feed were positive nasal

carriers of tetracycline-resistant

MRSA as compared to two

percent of workers employed at

antibiotic-free farms.11 In

addition, a specific MRSA strain

induced in hogs fed with

tetracycline has subsequently

been recovered from human

infection and has been found in

30 percent of tested

supermarket beef and pork and

on 10 percent of shopping cart

handles.12

Human use of antibiotics

represents 19.1 percent of

annual antibiotic use in the

United States.10 The most

commonly prescribed oral

antibiotics among all US

clinicians in 2010 were

azithromycin (166 Rx per 1,000

persons), amoxicillin (166 Rx

per 1,000 persons), amoxicillin-

clavulanate (70 Rx per 1,000

persons), ciprofloxacin (66 Rx

per 1,000 persons), and

cephalexin (65 Rx per 1,000

persons).8,9 When prescribing

patterns of a specific antibiotic

lead to a high prevalence of

emergence of an antibiotic-

resistant pathogenic bacteria,

studies have shown that

altering prescribing of the

antibiotic can reduce the

antibiotic resistance rate.13,14

Much of the data evaluating the

sensitivity of Propionibacterium

acnes to various antibiotics,

such as the tetracyclines and

clindamycin, are based on

studies that were completed 10

to 15 years ago. More recent

data shows increasing levels of

less sensitive P. acnes strains

to commonly used antibiotics,

with geographic variations

correlating with the frequency

of use of specific antibiotics.47

Over time, some strains of P.

acnes have become much less

sensitive to clindamycin, which

appears to reduce efficacy in

patients with AV who harbor a

high population of these less

sensitive organisms.

Oral isotretinoin induces

cutaneous changes that alter

the microbial flora. The

microbial effects include

reduction in P. acnes, decrease

in surface Gram-negative

bacteria, and increase in S.

aureus colonization.15

MRSA continues to be a

common cause of cutaneous

infection encountered in

outpatient clinics, including

dermatology. Updated practice

guidelines for the management

of skin and soft tissue

infections from the Infectious

Disease Society of America

have been published in 2014.16

The forthcoming AARS SPAUD

publication will include a wide range

of information on antibiotic

resistance and its significance to

dermatologists. A major objective is

to provide information useful to

clinicians in clinical practice. All of

the content for the AARS SPAUD

meeting was developed by the

faculty with Physician Resources,

LLC, obtaining scientific references

and providing logistical support.

Financial support for the meeting

was provided to the AARS from

some of its annual Corporate

Benefactors, including Allergan,

Bayer, Galderma, Merz, Promius,

and Valeant. The AARS is thankful

for this support, which reflects

dedication to education in

dermatology in this important and

far-reaching subject area. No

company (including the

aforementioned companies) nor

agencies or individuals directly or

indirectly affiliated with any

company, played any role in

influencing or providing material for

the content of the meeting or

decisions regarding faculty selection

and assignments.



REFERENCES

1. Del Rosso JQ, et al. Report from the

Scientific Panel on Antibiotic Use in

Dermatology: Usage Patterns, Manage-

ment, and Recommendations. Cutis.

2007;79(6S):660.

2. Del Rosso JQ, et al. Update from the

Scientific Panel on Antibiotic Use in

Dermatology: Clinical Considerations for

the Dermatologist. Cutis. 2008;82

(2S[ii]):320.

3. Hirschmann JV. When antibiotics are

unnecessary. Dermatol Clin. 2009;27:

7583.

4. Bowe WP, Leyden JJ. Clinical

implications of antibiotic resistance: risk

of systemic infection from

Staphylococcus and Streptococcus. In:

Shalita AR, Del Rosso JQ, Webster GF,

Eds. Acne Vulgaris. London, United

Kingdom: Informa Healthcare; 2011:

125133.

5. Leyden JJ, Del Rosso JQ, Webster GF.

Clinical considerations in the treatment of

acne vulgaris and other inflammatory skin

disorders: focus on antibiotic resistance.

Cutis. 2007;79(Suppl 6):925.

6. Del Rosso JQ, Leyden JJ, Thiboutot D,

Webster GF. Antibiotic use in acne

vulgaris and rosacea: clinical

considerations and resistance issues of

significance to dermatologists. Cutis.

2008;82(Suppl 2[ii]):512.

7. Levy RM, Huang EY, Roling D, et al. Effect

of antibiotics on the oropharyngeal flora

in patients with acne. Arch Dermatol.

2003;139(4):467471.

8. Sanchez G. Get smart: know when

antibiotics work. American Acne and

Rosacea Society And Scientific Panel on

Antibiotic Use in Dermatology Meeting.

Las Vegas, Nevada; September 6, 2014.

9. IMS Xponent Data; 2011.

10. Hollis A, Ahmed Z. Preserving antibiotics,

rationally. N Engl J Med. 2013:369:

24742476.

11. Rinsky JL, Nadimpalli M, Wing S, et al.

Livestock-associated methicillin and

multidrug resistant Staphylococcus

aureus is present among industrial, not

antibiotic-free livestock operation

workers in North Carolina. PLoS One.

2013;8(7):e67641.

12. Mole B. MRSA: farming up trouble.

Nature. 2013. 25;499(7459):398400.

13. Seppl H, Klaukka T, Vuopio-Varkila J, et

al. The effect of changes in the

consumption of macrolide antibiotics on

erythromycin resistance in group A

streptococci in Finland. Finnish study

group for antimicrobial resistance. N

Engl J Med. 1997;14;337(7):441-446.

14. Cristino MJ. Correlation between

consumption of antimicrobials in

humans and development of resistance

in bacteria. Int J Antimicrob Agents.

1999;12:199202.

15. James W, Leyden JJ. Treatment of gram-

negative folliculitis with isotretinoin:

positive clinical and microbiologic

response. J Am Acad Dermatol.

1985:12:319324.

16. Stevens DL, Bisno AL, Chambers HF, et

al. Practice guidelines for the diagnosis

and management of skin and soft tissue

infections: 2014 update by the infectious

diseases society of America. Clin Infect

Dis. 2014;59(2):147159.

Dr. James Leyden discusses the role of Propionibacterium acnes in acne patho-

physiology and the observation that antibiotic sensitivity of some P. acnes has

decreased. The prevalence of antibiotic-resistant P. acnes strains in a given geographic

location correlates directly with frequency of use in that region over time.

Dr. Richard Gallo presents on the cutaneous microbiome and effects that antibiotic and

antimicrobial use can cause beyond just the ability to eradicate a target bacterium.

Acne and rosacea research

stepped onto a larger stage at the

73rd Annual Meeting of the Society

for Investigative Dermatology (SID)

held in May in Albuquerque, New

Mexico. For the third consecutive

year, the American Acne and

Rosacea Society (AARS) hosted a

symposium highlighting the best

new studies germane to these

disease processes.

More than 120 research abstracts

submitted for the SID conference

were reviewed by the AARS and

seven were chosen for oral

presentation at the AARS

symposium, so as to consolidate

these projects into one informative

forum. Among them were studies

elucidating new inflammatory

markers and sebocyte biology in

acne. For instance, Hans Hofland,

PhD, from Dermira, Inc., in

Redwood, California, presented

information on a new compound in

clinical trials, an inhibitor of acetyl-

CoA carboxylase, which shows

promise in cell culture in changing

the size of sebaceous glands in the

hamster ear. This may affect sebum

production and therefore influence

acne therapy development.

Several presenters were

recipients of AARS Mentorship and

Research Grant Awards. Raja

Sivamani, MD, from UC Davis,

examined the role of milk peptides

in lipid production in the sebaceous

glands, reporting that bovine milk

peptides and lipoproteins can

activate lipogenesis and

inflammatory responses in

sebocytes, furthering our

understanding of the complex

interplay between diet and acne.

Also, an AARS Research Grant

Awardee, Yang Yu, BS, medical

student from UC Irvine and member

of Jenny Kim, MD, PhDs lab at UC

Los Angeles, presented pathogenic

differences between

Proprionibacterium acnes strains.

She reports that strains associated

with acne induce a greater TH1

cytokine response compared to

TH17 response, and strains

associated with healthy skin exhibit

a stronger anti-inflammatory IL-10

response, implying that there may

be ways to therapeutically target

specific P. acnes phylotypes based

on immunogenicity.

Dovetailing these findings, and

also from Dr. Kims lab, Andrew

Park, BA, current medical student at

Dartmouth, reported that IL-37,

member of the IL-1 family of

cytokines, may inhibit inflammatory

responses in association with P.

acnes in human keratinocytes,

further showcasing the breadth of

inflammatory pathways that may

influence acne.

Diane Thiboutot, MD, from Penn

State, former AARS President,

provided an update on the grant

from the National Institutes of

Health (NIH) to develop

standardized measures to assess

acne for use in clinical trials. This is

in collaboration with an international

team, including Drs. Alison Layton

and Anne Eady from the United

Kingdom, Dr. Jerry Tan from

Canada, and Drs. Meg Chren and

Diane Thiboutot from the United

States, currently studying global

assessment scales, lesion count

methods, and industry-supported

tools to design and utilize novel

technologies to assess acne in

clinical trials. More information

about the Acne Core Outcomes

Research Network (ACORN) can be

found at:

www.acnecoreoutcomes.org.

The AARS Annual Symposium,

with more than 150 participants,

continued to demonstrate a large

global interest from the dermatology

research community about acne and

rosacea innovation. The forum has

grown each year, and with the

support and foresight of AARS, it

showcased some of the best and

brightest researchers who will

influence our understanding of acne

and rosacea patients and their

management in the coming years.

For more information, please visit

the AARS website at:

www.acneandrosacea.org or contact

the society via email at:

[email protected].


3RD ANNUAL AARS RESEARCH SYMPOSIUM PRESENTED AT THE SOCIETY FOR INVESTIGATIVE DERMATOLOGY 2014 ANNUAL MEETING

Lorraine L. Rosamilia, MD, FAAD, AARS Education Committee

and Staff Physician, Geisinger Health System Department of Dermatology

Topicort_CREAM_Layout 1 8/11/14 4:02 PM Page 1

Topicort_CREAM_PI_Layout 1 8/11/14 4:04 PM Page 1


LETTER TO THE EDITOR

To the editor:

Acne is one of the most common

skin diseases, affecting more than 90

percent of adolescents.1 The severity

of acne in adolescents increases

with advancing maturity through the

teenage years.2 Although the

prevalence and severity of acne

scarring in the population is not

well-documented, the available

literature is usually correlated to the

severity of acne.3

Acne scars can present with

varying morphologies. One

morphologic acne scar classification

system includes three main types of

scars: ice pick, rolling, and boxcar.4

Some have also used the term

atrophic scars as a distinct entity or

as an all-encompassing term to refer

to these types of scars.5 Other less

common scars include sinus tracts,

hypertrophic scars, and keloidal

scars. Precise identification of the

scar subtype is important in guiding

therapeutic management.

Herein, the authors would like to

expand the acne scar classification

system by adding papular scars to

the existing dermatologic lexicon of

ice pick, rolling, and boxcar scars

(Figure 1). Papular scars are 3 to

4mm skin-colored cobblestone-like

papules distributed anywhere on the

body but, in our clinical experience,

most commonly on the chin (Figure

2a), nose, and back. Also known as

white papular acne scars, these

flesh-colored papules are often

incorrectly diagnosed as acne and do

not respond to traditional acne

treatments. Histologically, dermal

fibrosis consistent with scar is

present (Figure 4).

Papular scars can clinically mimic

closed comedones, acne, and

granulomas, leading to an

unnecessary delay in appropriate

treatment. Active acneiform lesions

causing any type of scars should be

treated aggressively with systemic

therapy to prevent further

progression of scarring.

A more specific and broader

classification system is important not

only for obtaining an accurate

clinical examination, but also for

designing targeted studies and

treatment protocols for papular

scars. Knowledge of this newly

described type of acne scar aids in

preventing a misdiagnosis of acne

and guides appropriate scar-directed

management. Future research

should be directed toward

comparative studies of scar

treatments, such as subcision, punch

excision, punch elevation, chemical

L E T T E R T O T H E E D I T O R

Papular Scars: An Addition

to the Acne Scar

Classification SchemeStephanie D. Gan, MD; Emmy M. Graber, MD, MBA

(J Clin Aesthet Dermatol. 2015;8(1):1920.)

Figure 1. Schematic of acne scar classification system. Ice pick scars are narrow, deep,

and extend vertically to the deep dermis or subcutaneous tissue. Rolling scars occur

from fibrous anchoring of the dermis to the subcutis, leading to superficial shadowing

and an undulating appearance to the overlying skin. Boxcar scars are round-to-oval

depressions with sharply demarcated vertical edges. Papular scars, unlike the depressed

morphology of ice pick, rolling, and boxcar scars, are exophytic in nature and produce a

cobblestone-like appearance.


peels, and lasers to determine the

most effective approach to treating

this newly classified scar subtype.

References1. Ghodsi SZ, Orawa H, Zouboulis

CC. Prevalence, severity, and

severity risk factors of acne in

high school pupils: a community-

based study. J Invest Dermatol.

2009;129:21362141.

2. Bhate K, Williams HC.

Epidemiology of acne vulgaris. Br

J Dermatol. 2013;168:474485.

3. Layton AM, Henderson CA,

Cunliffe WJ. A clinical evaluation

of acne scarring and its

incidence. Clin Exp Dermatol.

1994;19:303308.

4. Jacob CI, Dover JS, Kaminer MS.

Acne scarring: a classification

system and review of treatment

options. J Am Acad Dermatol.

2001;45:109117.

5. Alster TS, West TB. Treatment of

scars: a review. Ann Plast Surg.

1997;39:418432.

LETTER TO THE EDITOR

Figure 2. Representative flesh-colored,

34mm, soft, cobblestone-like papules

scattered on the chin.

Figure 3. Mild superficial perivascular lymphocytic infiltrate, telangiectasia, and

periappendageal dermal fibrosis consistent with scar (H&E, magnification 4X)

Dr. Gan is from the Department of Dermatology, University of Michigan Medical School, Ann Arbor, Michigan. Dr. Graber

is from the Department of Dermatology, Boston University School of Medicine, Boston, Massachusetts. Disclosure: The

authors report no relevant conflicts of interest. Address correspondence to: Stephanie Gan, MD, University of Michigan

Medical School, 1500 E. Medical Center Drive, Department of Dermatology, 1910 Taubman Center, Ann Arbor, MI 48109;

E-mail: [email protected]

[ J a n u a r y 2 0 1 5 V o l u m e 8 n u m b e r 1 ]22 22

[ O R I g I n A l R e S e A R C H ]

DISCLOSURE: Dr. Del Rosso is a consultant, serves on advisory boards, participates as a speaker, and conducts research for GaldermaLaboratories, L.P. He also serves as a consultant, participates in advisory boards, is a speaker, and/or conducts research for several other

companies who market medications for acne and/or skin care products and/or conduct research on such products including Allergan, Aqua,

Dermira, Innocutis, Promius, PuraCap, Ranbaxy, Valeant, and Unilever. Dr. Gold was the principal investigator for Galderma Laboratories, L.P., on

this study. Dr. Rueda, Ms. Brandt, and Dr. Winkelman are employees of Galderma Laboratories, L.P.

ADDRESS CORRESPONDENCE TO: Maria Jose Rueda, MD; E-mail: Marie-Jose.Ruedaalderma.com

Efficacy, Safety, and Subject Satisfaction of aSpecified Skin Care Regimen to Cleanse,

Medicate, Moisturize, and Protect the Skin ofPatients Under Treatment for Acne Vulgaris

aJAMES Q. DEL ROSSO, DO, FAOCD; bMICHAEL GOLD, MD, PhD; cMARIA JOS RUEDA, MD; cSTACI BRANDT,PA-C; cWARREN J. WINKELMAN, MD, PhD

aLas Vegas Skin and Cancer Clinics/West Dermatology, LLC, Henderson, Nevada; bGold Skin Care Center, Nashville, Tennessee; cGalderma Laboratories, L.P., Fort Worth, Texas

The availability of both prescription (Rx) medications,

advanced over-the-counter (OTC) skin care

formulations, and other OTC therapeutic and skin

care options have allowed clinicians to select more

complete treatment regimens that are better suited for

patient-specific management of acne vulgaris (AV).

However, the plethora of OTC options for AV that are

available in pharmacies, retail stores, spas, and skin care

centers, and via the internet are confounding to patients, as

are the many skin care products promoted to the public.

Without the professional knowledge provided by a

dermatologist and their clinical staff, the patient is likely to

choose a collection of products that will not adequately

control their AV and/or reduce damage to the epidermal

barrier that can cause signs and symptoms of skin irritation.

Importantly, the fundamental goal common to all

patients when the clinician is devising a management plan

for AV remains unchanged. That is, to provide optimal

treatment outcomes for patients with AV through

dedicated patient evaluation, rational selection of

pharmacological therapy, and integration of an adjunctive

skin care regimen that further supports a favorable

therapeutic outcome and avoids skin tolerability reactions.

There are four major components of a complete AV

management regimen based on the characteristics of acne-

prone skin and acne-treated skin and current

understanding of maintaining the structural and functional

integrity of the epidermal barrier: 1) cleansing, 2)

medicating, 3) moisturizing, and 4) photoprotection.13

Most dermatologists, and their extenders who work with

ABSTRACTOptimal management of acne vulgaris requires incorporation of several components including patient education, selection

of a rational therapeutic regimen, dedicated adherence with the program by the patient, and integration of proper skin care.

Unfortunately, the latter component is often overlooked or not emphasized strongly enough to the patient. Proper skin care

may reduce potential irritation that can be associated with topical acne medications and prevents the patient from

unknowingly using skin care products that can actually sabotage their treatment. This article reviews the effectiveness, skin

tolerability, safety, and patient satisfaction of an open label study in which a specified skin care regimen is used in combination

with topical therapy. The study was designed to mirror real world management of facial acne vulgaris clinical practice. The

skin care regimen used in this study included a brand foam wash and a brand moisturizer with SPF 30 photoprotection, both

of which contain ingredients that are included to provide benefits for acne-prone and acne-affected skin.

(J Clin Aesthet Dermatol. 2015;8(1):2230.)

[ J a n u a r y 2 0 1 5 V o l u m e 8 n u m b e r 1 ] 23

them in dermatology practices, feel very well-versed at

selecting Rx medications for AV; however, many do not

consistently recommend a specified skin care regimen

when treating patients with AV, thus allowing patients to

select skin care products on their own or by others

unknown to their physician.2 As a result, the skin care

regimen selected by the patient or by someone other than

the clinician treating their AV may not be appropriate for

use in the management of AV, especially when the patient

is utilizing acne medications.

Many Rx treatments, despite their effectiveness for AV,

can cause epidermal barrier impairment as evidenced by

increased transepidermal water loss (TeWl) and

decreased stratum corneum (SC) water content

(hydration), which can induce inflammation and may

increase skin sensitivity when facial skin is exposed to

personal hygiene products, certain cosmetics, and topical

medications.4,5 To add, acne-affected skin may be associated

with inherent SC abnormalities, especially with greater

severity of AV.5 Another important factor that influences

skin care needs is that some therapies for AV predispose

patients to photosensitivity (i.e., tetracyclines), even when

exposed to lower levels of ultraviolet (UV) light, with official

labeling approved by the United States Food and Drug

Administration (FDA) for Rx products containing benzoyl

peroxide and/or topical retinoids including

recommendations to use sunscreens and to avoid sun and

sunlamp exposure.611 In some cases, certain OTC products

and cosmetics and some facial skin beauty treatments can

cause skin irritation, exacerbate AV, and/or induce

acneiform eruptions, thus countering the positive effects of

Rx therapy for AV.12,13 Collectively, the potential adverse

consequences of improper concomitant skin care may be

problematic for some patients, compromising adherence,

overall therapeutic outcomes, and patient satisfaction with

their treatment, and in some cases their physician.1

Unfortunately, prospectively captured data are limited on

the combined use of designated skin care and Rx therapy in

patients with active AV.24 The following study provides data

on the concomitant use of a specific skin care regimen (i.e.,

cleanser, moisturizer with sunscreen) designed for acne-

prone and acne-treated skin in patients treated topically for

AV.1,1416

This open-phase, single-arm, observational, eight-week

study evaluated an AV management regimen consisting of

an Rx fixed combination topical gel containing adapalene

0.1% and benzoyl peroxide 2.5% (A-BPO) applied once

daily in subjects (n=81) with facial AV. As A-BPO has been

shown to be efficacious and well-tolerated, and is FDA-

approved for treatment of AV in subjects greater than nine

years of age, the inclusion criteria allowed for enrollment of

study subjects nine years of age and older with facial AV

rated as mild or moderate in severity.1721 All enrolled

subjects were treated with A-BPO once daily in

combination with two specified skin care products designed

for acne-prone skina foaming skin cleanser (Cetaphil

DermaControl Foam Wash, galderma laboratories l.P.,

Fort Worth, Texas) and a moisturizer with broad-spectrum

sun protection factor 30 (SPF 30) sunscreen (Cetaphil

DermaControl Moisturizer SPF 30, galderma laboratories

l.P.), referred to as the CoMMPlete Regimen. efficacy, skin

tolerability, safety, and patient satisfaction were evaluated

in all subjects. This article reports the results of this study,

discusses clinical relevance, and reviews the importance of

a practical and convenient comprehensive management

plan when treating patients with AV.

STUDY METHODS

The primary objective of this study was to assess total

AV lesion counts after eight weeks of use of A-BPO gel once

daily in conjunction with an acne-specific foam wash twice

daily and moisturizer with SPF 30 (broad spectrum). Other

objectives included evaluation of changes in the following

parameters:

Total AV lesion counts at Week 2 and Week 4

Change in inflammatory lesion counts (papules,

pustules)

Change in noninflammatory lesion counts

(comedones)

Cutaneous irritation after two weeks, four weeks, and

eight weeks

Quantitative change in facial skin shininess (Canfield

photographic system)

Quantitative change in skin texture (Canfield

photographic system)

Quantitative changes in Propionibacterium acnes

porphyrin fluorescence (Canfield photographic

system)

Subject questionnaire at Baseline and Week 8

Investigator questionnaire at Week 8.

Methodology. An open-label, multicenter study of

subjects 9 years of age with mild or moderate AV who met

other inclusion/exclusion criteria and were appropriately

consented to being enrolled. The study, conducted in the

United States, examined the change in AV lesion counts in

study subjects using A-BP0 gel, applied once daily, in

conjunction with a designated foam wash twice daily, and

designated moisturizer SPF 30, once daily, in the morning.

There were five (5) visits over the course of the study:

screening, visit 1 (Baseline), visit 2 (Week 2), visit 3 (Week

4) and visit 4 (Week 8, study endpoint). Subjects used only

the provided study products as directed for facial AV over a

duration of eight weeks. In the event of a premature

termination, exit study procedures were performed as soon

as possible.

AV lesion counts and cutaneous tolerability assessments

were completed at all study visits with a study treatment

questionnaire completed by the investigator at Week 4 and

at end of the study. Photographic evaluation for facial skin

shininess, skin texture, and P. acnes porphyrin

fluorescence were completed at all study visits. Adverse

event assessments were conducted at every visit;

compliance assessments were also completed.

All efficacy analyses and questionnaires were completed

based on the intent-to-treat (ITT) population, which

included all subjects who had at least one post-treatment

[ J a n u a r y 2 0 1 5 V o l u m e 8 n u m b e r 1 ]24 24

administration evaluation. last observation carried forward

(lOCF) was used to impute missing efficacy data for this

population excluding data collected at exit. Completed

subject questionnaires were analyzed additionally using as

observed population, which was defined as all subjects

who were enrolled and received at least one dose of any

study product. Missing data was excluded from the analysis.

The safety population was inclusive of all subjects who used

at least one application of study products.

Subject inclusion criteria.

Men and women aged nine years and older

Agreed to be photographed at each visit

Diagnosed with AV of mild or moderate severity (see

below) by a board-certified dermatologist and eligible

for treatment with A-BPO gel per the package insert

Women of childbearing potential must have had a

negative urine pregnancy test at the clinic at

Baseline/visit 1 and must have agreed to abstinence

or, if sexually active, practiced two forms of effective

birth control methods accepted as defined by the

study protocol for the duration of the study

Agreed to use the provided study products as their

only AV treatment, facial wash and facial moisturizer,

for the duration of the study

Agreed to refrain from temporary and permanent

tattoos, paint, or other facial art (including, but not

limited to piercings), cosmetic procedures, and

devices (including, but not limited to facial peels,

microdermabrasion, and Clarisonic) on the face for

the duration of the study

Apprised of Health Insurance Portability and

Accountability Act (HIPAA) requirements and

applicable state Bill of Rights

Able to follow instructions, study procedures, and

likely to complete all required visits

Patients aged 9 to 17 years who were able and willing

to read and provide written consent through an assent

form in conjunction with a parent/legally authorized

representative who was able and willing to read and

provide written consent prior to any study-related

procedure or patients aged 18 and older who were

able and willing to read and provide written informed

consent prior to any study-related procedures.

Subject exclusion criteria.

Presence of facial nodules and cysts

Female patients who were pregnant, nursing or

planning a pregnancy during the study

Facial hair, a degree of skin pigmentation, abnormal

pigmented vascular skin lesions, abnormal skin

pigmentation, or body art (tattoos, permanent or

temporary) on the face, which could interfere with

subsequent study evaluations

Any systemic or dermatological disorder, a known

history of allergies or other medical conditions, which

in the opinion of the investigator could interfere with

the conduct of the study, interpretation of results, or

increase the risk of adverse reactions

Any known allergies to any of the ingredients listed on

the study product labels (refer to the study drug

approved package insert)

Participated in another interventional, investigational

drug or device research study within 30 days of

enrollment

Study site staff or sponsor staff, relatives of site staff

or sponsor, or other individuals who had access to the

clinical study protocol

Patients with a washout period less than one week for

OTC topical AV treatments (with active ingredients,

such as benzoyl peroxide, salicylic acid, sulfur, and

resorcinol), prescription topical AV treatments,

topical corticosteroids, and use of cosmetic devices

(such as Clarisonic or similar devices), or less than

four weeks for topical retinoids

Washout period less than four weeks for systemic Rx

treatment for AV and systemic corticosteroids and

less than 24 weeks for oral retinoids

Presence of sunburn, eczema, atopic dermatitis,

perioral dermatitis, rosacea, or other skin conditions

on the area to be treated

Patients at risk in terms of precautions, warnings, and

contraindications (refer to the study drug package

insert)

Patients who anticipate unprotected and intense UV

exposure during the study (mountain sports, UV

radiation, sunbathing, etc.)

Any visible skin condition or facial hair that would

interfere with the evaluations

Patients taking or planning to take topical or systemic

medications to treat AV during the course of the trial

Patients taking other medications, supplements, or

non-prescription treatments that, in the opinion of the

investigator could interfere with study results

including any regimen of steroidal/nonsteroidal anti-

inflammatory drugs, antihistamines, or anabolic

steroids

Under treatment for asthma or diabetes (insulin-

dependent only)

Surgical or cosmetic procedures planned or

completed during the course of the trial

History of facial procedures within the last 90 days

(cosmetic surgery, microdermabrasion, chemical

peels, intense pulsed light, fillers, botulinum toxins

[i.e., Botox], lasers, photodynamic therapy, red and

blue light therapy, etc.).

Acne severity.

Mild-to-moderate facial AV severity rating.

20 to 50 inflammatory facial lesions (papules and/or

pustules excluding the nose)

30 to 100 noninflammatory facial lesions (open

comedones and/or closed comedones excluding the

nose).

Daily regimen (CoMMPlete Regimen). Adapalene

0.1%/benzoyl peroxide 2.5% gel (epiduo gel, galderma

laboratories l.P.) applied once daily; specified foam wash

(Cetaphil DermaControl Foam Wash) used twice daily;

specified moisturizer SPF 30 (Cetaphil DermaControl


Moisturizer SPF 30) applied once daily. epiduo gel Pump,

Cetaphil DermaControl Foam Wash (twice daily) and

Cetaphil DermaControl Moisturizer SPF 30 (once daily)

were provided to each enrolled patient with instructions to

use only these products for facial AV over the entire study

duration.

Study duration. eight weeks.

Study assessments.

lesion counts (total, inflammatory, noninflammatory)

Photographic evaluations using designated Canfield

system (skin shininess, skin texture, P. acnes

porphyrin fluorescence)

Cutaneous tolerability scores (stinging/burning,

erythema, scaling, dryness)

Adverse events (Aes)

Subject questionnaires

Investigator questionnaire.

Treatment compliance. Adherence with the study

treatment regimen by the subject was based on the

questioning of the subject at each visit and the weight of

study products at dispensation and end of study. Subjects

were considered compliant with the treatment regimen if

they utilized at least 80 percent, but no more than 120

percent, of the expected doses during participation in the

study.

Study discontinuations. Any study patient was free to

discontinue participation in the study at any time for any

reason, specified or unspecified. Those who discontinued

the study prematurely were fully evaluated whenever

possible. The reason for premature discontinuation was

carefully documented by the investigator on the exit form,

and, if applicable, on the Ae form. When applicable, the

investigator was to ensure that subjects who discontinued

prematurely received appropriate therapy for their

condition.

Statistical methods. For all efficacy variables,

descriptive statistics were computed based on the nature of

the variable (continuous or categorical). Subject

disposition, demographics, baseline characteristics,

previous therapies, concomitant therapies, and treatment

duration were summarized by descriptive statistics. The

change and percent change from baseline in total lesion

counts was analyzed by t-tests and signed rank tests for the

mean and median, respectively.

Aes were tabulated in frequency tables by treatment,

system organ class (SOC), and preferred term (PT) based

on the Medical Dictionary for Regulatory Activities

(MedDRA) dictionary. Ae summary tables were based on

the number of subjects who experienced an Ae. For a given

Ae, subjects were counted once even if they experienced

multiple episodes for that particular Ae.

Study demographics. The study demographics and

baseline characteristics of enrolled subjects are depicted in

Table 1. The demographic and baseline characteristics for

the ITT population (n=77) were similar to the safety

population (n=81). The majority of study subjects were

Caucasian or Black/African American with a mean age of

19.1 years and a mean duration of AV of 4.4 years.

Study disposition. The disposition of study subjects is

outlined in Table 2.

STUDY OUTCOMES

eighty-one subjects 12 years of age or older, with mild-

to-moderate AV were enrolled with data from 77 subjects

eligible for efficacy analysis and data from 81 subjects

available for safety analysis. Most subjects were Caucasian

or Black/African American with a mean age of 19.1 years

and a mean duration of AV of 4.4 years.

Lesion counts. At Baseline, the mean number of total

AV lesions was 76.7 (range 52.0145.0), the mean number

of inflammatory lesions was 27.3 (range 20.048.0), and

TABLE 1. Summary of demographic and baseline characteristics(ITT population)

CoMMPlete REGIMEN

Age (in years)Mean (SD)Median(Min, max)

19.1 (8.0)16(12.0, 52.0)

Gender, n (%)MaleFemale

39 (50.6)38 (49.4)

Ethnicity, n (%)Hispanic or LatinoNot Hispanic or Latino

16 (20.8)61 (79.2)

Race, n (%)CaucasianBlack or African AmericanAsianAmerican Indian or Alaska NativeOther

45 (58.4)23 (29.9)4 (5.2)1 (1.3)4 (5.2)

Skin type, n (%)NormalOilyDryCombination

22 (28.6)29 (37.7)5 (6.5)21 (27.3)

Fitzpatrick skin type, n (%)IIIIIIIVVVI

3 (3.9)19 (24.7)16 (20.8)18 (23.4)12 (15.6)9 (11.7)

History of acne (years)Mean (SD)Median(Min, max)

4.4 (4.8)2.9(0.0, 21.8)

CoMMPlete Regimen = Epiduo Gel Pump once daily in conjunction withCetaphil DermaControl Foam Wash twice daily and Cetaphil

DermaControl Moisturizer SPF 30 once daily

[ J a n u a r y 2 0 1 5 V o l u m e 8 n u m b e r 1 ]26

the mean number of noninflammatory (comedonal) lesions

was 49.4 (range 30.5100.0). The studied management

regimen demonstrated an early onset of therapeutic effect

with lesion reductions noted at two weeks, and with

continued progressive reductions in AV lesion counts noted

throughout the eight-week study. Mean percent change

from baseline in total AV lesion counts are shown in Figure

1, with a 30.6 percent reduction at Week 2, 35.9 percent at

Week 4, and 44.0 percent reduction at Week 8 (p


recommending a regimen formulated

specifically for patients with AV is

important, that they were satisfied

with this regimen in treating patients

with AV, that they would recommend

this regimen to patients with AV, and

that recommending a skin care

regimen that includes a moisturizer

with sunscreen (SPF) specifically

made for acne-prone skin is

important to them.

Tolerability/safety data. Most

subjects did not experience

cutaneous irritation (erythema,

scaling, dryness, stinging/burning) at

sites of use and/or application of the

studied products and no subjects

experienced severe skin irritation

(Table 3; Table 4). Overall, a

decrease in signs and symptoms of

skin irritation were noted when the

worst post-baseline scores from this

study (n=77) were compared to the

Phase 2 and Phase 3 studies that

evaluated A-BPO gel once daily

(n=533) by Week 8 in a similar

patient population of subjects with

AV except that the latter enrolled

subjects 12 years of age or older

(Table 4).1719

In the current study, a total of 13

subjects reported 18 Aes, with 17

considered by the investigator to be

related to the three-component

regimen (CoMMPlete Regimen). no

subjects discontinued use of the

complete three-component regimen

due to Aes and no serious Aes were

reported during the study.

Compliance assessment. Seventy-six study subjects

(93.8%) were considered compliant with the entire

treatment regimen. Four subjects were not fully compliant

with use of A-BPO gel or the foam wash treatment and five

subjects were not fully compliant with moisturizer SPF 30

treatment.

DISCUSSIONWhen devising a management plan for AV, it is important

to achieve four primary fundamental goals: cleansing,

medicating, moisturizing, and protecting against the

adverse effects of sunlight and UV exposure. These four

important goals are inherent to a complete regimen that

serves to optimize therapeutic outcomes for the patient,

primarily by mitigating impairment of the epidermal barrier

and its associated skin sensitivity that may be caused by

climatic factors (i.e., low humidity), topical medications,

and a variety of OTC skin products.35 Some important

considerations when selecting a complete treatment

regimen that incorporates adjunctive skin care are the

onset of therapeutic effect, impact on skin tolerability and

irritation, moisturizer tolerability, sunscreen tolerability,

overall patient satisfaction with the therapeutic outcome,

and patient satisfaction with the skin care products

themselves.

Use of a moisturizer with sunscreen is an important

recommendation for patients with AV. This is especially

true in those using topical AV therapy and in those treated

with oral antibiotics associated with increased risk of

photosensitivity. The moisturizer component assists in

mitigating epidermal barrier impairment and its related skin

sensitivity and irritation.15 Both the moisturizer and

sunscreen components can assist in prevention of residual

hyperpigmentation, which can result from skin irritation

and inflammation, especially in individuals with darker skin.

The sunscreen component may also protect against

photosensitivity induced by UV radiation in patients using

certain Rx medications for AV.611 It is important to

Figure 3. Mean percent change from baseline in noninflammatory lesion counts

*p

[ J a n u a r y 2 0 1 5 V o l u m e 8 n u m b e r 1 ]28

recognize that many sunscreens can induce skin irritation

and some moisturizers and sunscreens can be acnegenic

and comedogenic in a subset of patients.2,12,1416 The specific

moisturizer SPF 30 formulation used in this study as part of

the complete three-component regimen incorporates its

sunscreen ingredients in a vehicle technology that allows

for a broad-spectrum SPF 30 rating using a markedly lower

concentration of sunscreens as compared to many other

commercially available OTC moisturizer products with

sunscreen, thus lowering the potential for irritant skin

reactions.1,14,16 To add, the same specific moisturizer SPF 30

formulation has been shown not to be acnegenic or

comedogenic and did not exacerbate or worsen AV with

continued use, including in subjects using a variety of Rx

products for AV.16 Additional characteristics of the specific

foam cleanser and the moisturizer SPF 30 and study data

with these formulations have been published elsewhere.1,14,16

Ultimately, it is prudent for the clinician to use medications

for the AV patient that are well-studied, effective, and safe,

and to incorporate a concomitant skin care regimen shown

to provide adjunctive benefits that optimize the potential

for positive therapeutic outcomes.

Another important factor when treating AV is to

recommend a management regimen that minimizes factors

that are likely to diminish patient satisfaction and adherence

(such as inadequate or slow response to therapy, too

complicated, too many products, inconvenient, increased risk

of skin irritation or other side effects, etc).7,12 An early onset

of therapeutic effect is very favorable from the perspective of

the patient as it reflects that the treatment regimen is

working. In addition, use of a complete management program

that is associated with a low risk of cutaneous irritation is

important as it reduces the likelihood that a patient will stop

treatment due to signs and symptoms of skin irritation that

can be associated with topical acne therapy. If a patient is

forced to stop applying their acne medication because of skin

irritation, the result of interrupted treatment is a marked

delay in improvement which is frustrating for both the

patient and the clinician. From the perspective of the

clinician, it is important to devise a management program for

AV treatment that is convenient and efficacious, produces

both early and sustained visible therapeutic effects, and is

well-tolerated in order to enhance patient adherence and

overall satisfaction.1,16,22

Figure 5. Subject responses at baseline regarding the importance of using a moisturizer with sunscreen

Figure 6. Subject responses at end of study regarding the importance of using a moisturizer with sunscreen made for acne-prone skin


SUMMARY

The results of this eight-week study support the use of a

complete management approach that incorporates an acne-

specific skin care regimen (specified foam wash and

moisturizer SPF 30) and a single fixed-dose combination Rx

topical gel containing adapalene 0.1% and benzoyl peroxide

2.5% that is applied once daily for patients with mild or

moderate AV. Outcome data demonstrated effective AV

treatment with an early onset of therapeutic benefit; good

skin tolerability with broad-spectrum SPF 30

photoprotection; safe use in patients 12 years of age or

older; use of specific skin care products that do not

exacerbate, worsen, or induce AV and do not interfere with

medication efficacy; a convenient and complete regimen

with one topical Rx product, a specific facial cleanser used

twice daily, and a single moisturizer SPF 30 product applied

once daily; and a high degree of overall patient satisfaction.

The outcomes of this study support that this three-

component topical regimen may provide many adult and

pediatric patients affected by mild-to- moderate AV with a

complete management program that is convenient, easy to

use, effective, well-tolerated, and likely to produce a high

level of patient satisfaction.

REFERENCES

1. Del Rosso JQ. The role of skin care as an integral component in

the management of acne vulgaris: part 1: the importance of

cleanser and moisturizer ingredients, design, and product

selection. J Clin Aesthet Dermatol. 2013;6:1927.

2. goodman g. Cleansing and moisturizing in acne patients. Am J

Clin Dermatol. 2009;10(Suppl 1):16.

3. Del Rosso JQ, levin J. The clinical relevance of maintaining the

TABLE 3. Adverse events (safety population)

SYSTEM ORGAN CLASS,PREFERRED TERM

CoMMPlete REGIMEN (N = 81)a

SUBJECTS, n (%) EVENTS, n

All events 13 (16.0) 18

Skin and subcutaneous tissuedisorders

ErythemaDry skinSkin exfoliationSkin irritationSkin burning sensation

6 (7.4)4 (4.9)2 (2.5)1 (1.2)1 (1.2)

64211

General disorders and administration site conditions

Pain2 (2.5) 2

Injury, poisoning and proceduralcomplications

Muscle strainAccidental exposure to productby child

1 (1.2)1 (1.2)

11

aCoMMPlete Regimen = Epiduo Gel Pump once daily + CetaphilDermaControl Foaming Wash twice daily and Cetaphil DermaControlMois

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