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

June 4, 2010
April 4, 2013
June 2010
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the IGA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Total Lesion Counts [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01138735 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percent Change in Lesion Counts [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in Non-inflammatory & Inflammatory Lesion Counts [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acne
  • Drug: adapalene/benzoyl peroxide
    daily topical application for 12 weeks
    Other Name: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%
  • Drug: Topical Gel Vehicle
    daily topical application for 12 weeks
    Other Name: Topical Gel Vehicle
  • Active Comparator: adapalene/benzoyl peroxide
    Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
    Intervention: Drug: adapalene/benzoyl peroxide
  • Placebo Comparator: Topical Gel Vehicle
    Topical Gel Vehicle applied topically once daily for 12 weeks
    Intervention: Drug: Topical Gel Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
285
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
9 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01138735
RD.06.SPR.18155
No
Galderma
Galderma
Not Provided
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
Galderma
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP