Epiduo Pediatric Acne Study - Full Text View

Purpose

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	Intervention	Phase
Acne	Drug: adapalene/benzoyl peroxide Drug: Topical Gel Vehicle	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

Success Rate [ Time Frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF]) ] [ Designated as safety issue: No ]
Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)
Change From Baseline in Total Lesion Counts [ Time Frame: Baseline to Week 12 (LOCF) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change in Total Lesion Counts From Baseline [ Time Frame: Baseline to Week 12 (LOCF) ] [ Designated as safety issue: No ]
Change in Inflammatory Lesion Counts From Baseline [ Time Frame: Baseline to Week 12 (LOCF) ] [ Designated as safety issue: No ]

Enrollment:	285
Study Start Date:	June 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: Topical Gel Vehicle

Eligibility

Ages Eligible for Study:	9 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138735

Show 25 Study Locations

Sponsors and Collaborators

Galderma

Investigators

Study Director:	Michael Graeber, MD	Galderma
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

More Information

No publications provided

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT01138735 History of Changes
Other Study ID Numbers:	RD.06.SPR.18155
Study First Received:	June 4, 2010
Results First Received:	February 19, 2013
Last Updated:	April 4, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013