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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
www.jcadonline.comwww.jcadonline.com
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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Special Issue: Common Facial Dermatoses
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EDITORIAL CORRESPONDENCE should be directed to:Kimberly B. Chesky, Executive Editor, JCADMatrix Medical Communications1595 Paoli Pike, Suite 201West Chester, PA 19380Toll-free: (866) 325-9907; Phone: (484) 266-0702Fax: (484) 266-0726. Website: www.jcadonline.com.E-mail: [email protected]
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Copyright 2015 Matrix MedicalCommunications. All rights reserved. Opinionsexpressed by authors, contributors, andadvertisers are their own and not necessarilythose of Matrix Medical Communications, theeditorial staff, or any member of the editorialadvisory board. Matrix Medical Communicationsis not responsible for accuracy of dosages givenin the articles printed herein. The appearance ofadvertisements in this journal is not a warranty,endorsement, or approval of the products orservices advertised or of their effectiveness,quality, or safety. Matrix MedicalCommunications disclaims responsibility for anyinjury to persons or property resulting from anyideas or products referred to in the articles oradvertisements. For reprint information andpricing, contact Matrix MedicalCommunications.
The Journal of Clinical and Aesthetic Dermatology(ISSN 1941-2789) is published 12 times yearly byMatrix Medical Communications. The journal isprinted by Publishers Press, Shepherdsville,Kentucky. Printed in the United States of Americaon acid-free paper.
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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
PARTNER
Patrick D. Scullin
(484) 266-0702
VICE PRESIDENT, PUBLISHER
Joseph J. Morris
(484) 266-0702
VICE PRESIDENT
Elizabeth A. Klumpp
(484) 266-0702
EXECUTIVE EDITOR
Kimberly B. Chesky
(484) 266-0702
ASSOCIATE EDITOR
Angela M. Hayes
(484) 266-0702
The official journal of American Acne & Rosacea Society
Inde
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The Journal of Clinical and AestheticDermatology is indexed in the followingreference sources:
PubMed CentralCINAHLEMBASEScopus
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[ 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
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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
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[ 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 ]8
Special IssueCommon Facia l Dermatoses
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[ 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 ]10
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
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[ 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
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
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Letters to the Editor, please indicate whether the
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Conflict of Interest Disclosures. All authors
should disclose any potential financial conflicts of
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Informed Consent. Informed consent should be
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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
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return an Author Form, which requires corresponding
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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)
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MANUSCRIPT PREPARATION
Title Page. The title page should contain the
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[ 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 ]12
following elements: title, author names and
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name of corresponding author with his or her complete
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Spacing and Pagination. Please use double
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Please line number all submissions for the benefit of
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Keywords. Include all relevant keywords
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Abbreviations/Acronyms. All abbreviations and
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References. Citation accuracy is the
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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
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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
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and-white or color photographs, the required
resolution is at least 300 dpi. For line drawings, the
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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
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
www.jcadonline.com
INFORMATION FOR AUTHORS
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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)
-
[ 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 ] 15
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.
16 [ 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 ]
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[ 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 ] 17
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:
18 [ 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 ]
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
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[ 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 ] 1919
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.
-
[ 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 ]20
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]
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[ 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.)
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[ 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
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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
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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
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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
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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
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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
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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