Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

Sponsor

BioWest Therapeutics Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00211497

Collaborator

(none)

255

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris Acne Propionibacterium Acnes	Drug: MBI 226 Acne Solutions	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase II, Randomized, Vehicle-Controlled, Double-Blind, Multi-Center Study to Evaluate Safety and Efficacy of MBI 226 1.25% and 2.5% Acne Solutions Applied Topically for 12 Weeks to Subjects With Acne Vulgaris

Study Start Date :

Jan 1, 2003

Study Completion Date :

Sep 1, 2003

Outcome Measures

Primary Outcome Measures

- percent change from Baseline to Week 12 in inflammatory acne lesion counts []

Secondary Outcome Measures

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 []