Epiduo Pediatric Acne Study

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.

Conditions

• Acne

Interventions

DRUG

adapalene/benzoyl peroxide

daily topical application for 12 weeks

DRUG

Topical Gel Vehicle

daily topical application for 12 weeks

Sponsors & Collaborators

• Galderma R&D

  lead INDUSTRY

Principal Investigators

• Michael Graeber, MD · Galderma R&D

• Lorne Albrecht, MD · Guildford Dermatology Specialists

• Zoe Draelos, MD · Zoe Draelos, MD

• Lawrence Eichenfield, MD · Childrens Hospital and Health Center Division of Pediatric and Adolescent Dermatology

• Boni Elewski, MD · UAB Dermatology Clinical Research

• Alan Fleischer, MD · Department of Dermatology Wake Forest University Health Sciences

• Francisco Flores, MD · FXM Research Miramar

• Joseph Fowler, MD · Dermatology Specialists Research

• Robert Haber, MD · Haber Dermatology Clinical Research Center

• Adelaide Hebert, MD · The University of Texas Health Science Center, Houston

• Michael Heffernan, MD · Central Dermatology, PC

• David Kaplan, MD · Adult & Pediatric Dermatology

• Steven Kempers, MD · Minnesota Clinical Study Center A Division of Associated Skin Care Specialist, PA

• Rodion Kunynetz, MD · Ultranova Skincare

• Ian Landells, MD · Nexus Clinical Research

• Charles Lynde, MD · Lynderm Research Inc.

• Russell Mader, MD · Dermatology Associates of Kingsport, PC

• Lew Andrew Rosoph, MD · North Bay Dermatology Centre

• Joel Schlessenger, MD · Skin Specialists, PC

• Michael Spigarelli, MD · Children's Hospital Medical Center, Cincinnati

• Linda Stein Gold, MD · Henry Ford Health Systems - Department of Dermatology

• Jeffrey Sugarman, MD · Redwood Family Dermatology

• William Werschler, MD · Premier Clinical Research

• Patricia Westmoreland, MD · Palmetto Clinical Trial Services, LLC

• Andrea Zaenglein, MD · Penn State Milton S. Hershey Medical Center - Penn State College of Medicine

• George Murakawa, MD · Dermcenter PC; Somerset Skin Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

9 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• United States
• Canada

Study Locations