Epiduo Pediatric Acne Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01138735
First received: June 4, 2010
Last updated: April 4, 2013
Last verified: April 2013
  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:


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 April 22, 2014