Epiduo Pediatric Acne Study

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138735
• Other study ID #: RD.06.SPR.18155
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

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)