Status:
COMPLETED
Epiduo Pediatric Acne Study
Lead Sponsor:
Galderma R&D
Conditions:
Acne
Eligibility:
All Genders
9-11 years
Phase:
PHASE4
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT01138735
Start Date
June 1 2010
End Date
August 1 2011
Last Update
February 18 2021
Active Locations (25)
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1
UAB Dermatology Clinical Research
Birmingham, Alabama, United States, 35233
2
Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology
San Diego, California, United States, 92123
3
Redwood Family Dermatology
Santa Rosa, California, United States, 95403
4
FXM Research Miramar
Miramar, Florida, United States, 33027