Epiduo Pediatric Acne Study

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide

Criteria

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