Epiduo Pediatric Acne Study

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

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: adapalene/benzoyl peroxide; Drug: Topical Gel Vehicle

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Guildford Dermatology Specialists
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1A 5E8
      • Nexus Clinical Research
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Ultranova Skincare
    • Markham, Ontario, Canada, L3P 1A8
      • Lynderm Research, Inc
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Dermatology Clinical Research
  • California
    • San Diego, California, United States, 92123
      • Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology
    • Santa Rosa, California, United States, 95403
      • Redwood Family Dermatology
  • Florida
    • Miramar, Florida, United States, 33027
      • FXM Research Miramar
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Adult & Pediatric Dermatology
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health Systems Department of Dermatology
    • Troy, Michigan, United States, 48084
      • Dermcenter PC - Somerset Skin Centre
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology PC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Zoe Draelos, MD
    • Winston-Salem, North Carolina, United States, 27157
      • Department of Dermatology - Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cininnati Children's Hospital
    • South Euclid, Ohio, United States, 44118
      • Haber Dermatology Clinical Research Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Palmetto Clinical Trial Services, LLC
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Dermatology Associates of Kingsport, PC
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Sciences Center at Houston
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)	Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Change From Baseline in Total Lesion Counts		Baseline to Week 12 (LOCF)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Total Lesion Counts From Baseline	Baseline to Week 12 (LOCF)
Change in Inflammatory Lesion Counts From Baseline	Baseline to Week 12 (LOCF)

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Ian Landells, MD, Nexus Clinical Research; Principal Investigator: William Werschler, MD, Premier Clinical Research; Principal Investigator: Adelaide Hebert, MD, The University of Texas Health Science Center, Houston; 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: 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: 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: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Benzoyl Peroxide; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination
• Other Study ID Numbers: RD.06.SPR.18155