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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01138735
Other study ID # RD.06.SPR.18155
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2010
Est. completion date August 2011

Study information

Verified date April 2013
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 285
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 9 Years to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
adapalene/benzoyl peroxide
daily topical application for 12 weeks
Topical Gel Vehicle
daily topical application for 12 weeks

Locations

Country Name City State
Canada Ultranova Skincare Barrie Ontario
Canada Lynderm Research, Inc Markham Ontario
Canada North Bay Dermatology Centre North Bay Ontario
Canada Nexus Clinical Research St John's Newfoundland and Labrador
Canada Guildford Dermatology Specialists Surrey British Columbia
United States UAB Dermatology Clinical Research Birmingham Alabama
United States Cininnati Children's Hospital Cincinnati Ohio
United States Henry Ford Health Systems Department of Dermatology Detroit Michigan
United States Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA Fridley Minnesota
United States Palmetto Clinical Trial Services, LLC Greenville South Carolina
United States Penn State Milton S. Hershey Medical Center - Penn State College of Medicine Hershey Pennsylvania
United States Zoe Draelos, MD High Point North Carolina
United States The University of Texas Health Sciences Center at Houston Houston Texas
United States Dermatology Associates of Kingsport, PC Kingsport Tennessee
United States Dermatology Specialists Research Louisville Kentucky
United States FXM Research Miramar Miramar Florida
United States Skin Specialists, PC Omaha Nebraska
United States Adult & Pediatric Dermatology Overland Park Kansas
United States Central Dermatology PC Saint Louis Missouri
United States Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology San Diego California
United States Redwood Family Dermatology Santa Rosa California
United States Haber Dermatology Clinical Research Center South Euclid Ohio
United States Premier Clinical Research Spokane Washington
United States Dermcenter PC - Somerset Skin Centre Troy Michigan
United States Department of Dermatology - Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success Rate Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA) Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Primary Change From Baseline in Total Lesion Counts Baseline to Week 12 (LOCF)
Secondary Percent Change in Total Lesion Counts From Baseline Baseline to Week 12 (LOCF)
Secondary Change in Inflammatory Lesion Counts From Baseline Baseline to Week 12 (LOCF)
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