Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
Phase 2
Completed
- Conditions
- Acne VulgarisAcnePropionibacterium Acnes
- Registration Number
- NCT00211497
- Lead Sponsor
- BioWest Therapeutics Inc
- Brief Summary
This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
Inclusion Criteria
- Males and females 12 years and older
- Presence of inflammatory and non-inflammatory lesions
Exclusion Criteria
- Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
- Active facial cysts or any nodulocystic lesions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - percent change from Baseline to Week 12 in inflammatory acne lesion counts
- Secondary Outcome Measures
Name Time Method Single continuous endpoints: • Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts • The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts Multiple continuous endpoints: • Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts • Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts Categorical endpoints: • Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12 • PGSA absolute scores at Week 6 and Week 12 • PGSA absolute scores over Baseline, Week 6 and Week 12