Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
Phase 1
Completed
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT02709902
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
Bioequivalence with Clinical Endpoints.
- Detailed Description
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 460
Inclusion Criteria
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
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Exclusion Criteria
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adapalene/BP gel, 0.3%/2.5% Adapalene/BP gel, 0.3%/2.5% Topical, once daily, for 84 days. EPIDUO® FORTE EPIDUO® FORTE Topical, once daily, for 84 days. Placebo Placebo Topical, once daily, for 84 days.
- Primary Outcome Measures
Name Time Method Change in inflammatory lesion counts Week 12 Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts Week 12 Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
- Secondary Outcome Measures
Name Time Method Clinical response of success Week 12 The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment