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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 22, 2014