Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

Phase 2

Completed

• Conditions: Acne Vulgaris; Acne; Propionibacterium Acnes

• Registration Number: NCT00211523
• Lead Sponsor: BioWest Therapeutics Inc

Brief Summary

This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions, applied topically for six weeks, in the treatment of acne.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10
• Study Completion: 2001-09
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Posted: 2005-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Males and females, ages 13 and up, exhibiting high levels of facial P. acnes
• Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria

• Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.)
• Active facial cysts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment

Secondary Outcome Measures

Name	Time	Method
- percent change in lesion counts after ~2 and ~4 weeks
- Global Severity Assessment