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Epiduo Pediatric Acne Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01138735
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : March 26, 2013
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Drug: adapalene/benzoyl peroxide Drug: Topical Gel Vehicle Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris
Study Start Date : June 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: adapalene/benzoyl peroxide
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Drug: adapalene/benzoyl peroxide
daily topical application for 12 weeks
Other Name: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%

Placebo Comparator: Topical Gel Vehicle
Topical Gel Vehicle applied topically once daily for 12 weeks
Drug: Topical Gel Vehicle
daily topical application for 12 weeks

Primary Outcome Measures :
  1. Success Rate [ Time Frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF]) ]
    Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

  2. Change From Baseline in Total Lesion Counts [ Time Frame: Baseline to Week 12 (LOCF) ]

Secondary Outcome Measures :
  1. Percent Change in Total Lesion Counts From Baseline [ Time Frame: Baseline to Week 12 (LOCF) ]
  2. Change in Inflammatory Lesion Counts From Baseline [ Time Frame: Baseline to Week 12 (LOCF) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of acne vulgaris with facial involvement
  • Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
  • A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline

Exclusion Criteria:

  • Acne nodule or acne cyst
  • Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
  • Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
  • Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138735

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Sponsors and Collaborators
Galderma R&D
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Study Director: Michael Graeber, MD Galderma R&D
Principal Investigator: Lorne Albrecht, MD Guildford Dermatology Specialists
Principal Investigator: Zoe Draelos, MD Zoe Draelos, MD
Principal Investigator: Lawrence Eichenfield, MD Childrens Hospital and Health Center Division of Pediatric and Adolescent Dermatology
Principal Investigator: Boni Elewski, MD UAB Dermatology Clinical Research
Principal Investigator: Alan Fleischer, MD Department of Dermatology Wake Forest University Health Sciences
Principal Investigator: Francisco Flores, MD FXM Research Miramar
Principal Investigator: Joseph Fowler, MD Dermatology Specialists Research
Principal Investigator: Robert Haber, MD Haber Dermatology Clinical Research Center
Principal Investigator: Adelaide Hebert, MD The University of Texas Health Science Center, Houston
Principal Investigator: Michael Heffernan, MD Central Dermatology, PC
Principal Investigator: David Kaplan, MD Adult & Pediatric Dermatology
Principal Investigator: Steven Kempers, MD Minnesota Clinical Study Center A Division of Associated Skin Care Specialist, PA
Principal Investigator: Rodion Kunynetz, MD Ultranova Skincare
Principal Investigator: Ian Landells, MD Nexus Clinical Research
Principal Investigator: Charles Lynde, MD Lynderm Research Inc.
Principal Investigator: Russell Mader, MD Dermatology Associates of Kingsport, PC
Principal Investigator: Lew Andrew Rosoph, MD North Bay Dermatology Centre
Principal Investigator: Joel Schlessenger, MD Skin Specialists, PC
Principal Investigator: Michael Spigarelli, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Linda Stein Gold, MD Henry Ford Health Systems - Department of Dermatology
Principal Investigator: Jeffrey Sugarman, MD Redwood Family Dermatology
Principal Investigator: William Werschler, MD Premier Clinical Research
Principal Investigator: Patricia Westmoreland, MD Palmetto Clinical Trial Services, LLC
Principal Investigator: Andrea Zaenglein, MD Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
Principal Investigator: George Murakawa, MD Dermcenter PC; Somerset Skin Centre
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01138735    
Other Study ID Numbers: RD.06.SPR.18155
First Posted: June 7, 2010    Key Record Dates
Results First Posted: March 26, 2013
Last Update Posted: February 18, 2021
Last Verified: April 2013
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl Peroxide
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents