Title
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
Phase
Phase 4Lead Sponsor
GaldermaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
AcneIntervention/Treatment
adapalene benzoyl peroxide ...Study Participants
285The 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.
daily topical application for 12 weeks
daily topical application for 12 weeks
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle applied topically once daily for 12 weeks
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
| Event Type | Organ System | Event Term | Adapalene/Benzoyl Peroxide | Topical Gel Vehicle |
|---|
Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)
