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

• Sponsor: BioWest Therapeutics Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00211523
• Collaborator: (none)
• Enrollment: 75
• Duration (Months): 11

Study Details

Study Description

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.

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: Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of MBI 226 2.5% and 5.0% Acne Solutions Applied Topically for 6 Weeks to Subjects With Acne Vulgaris
• Study Start Date: Oct 1, 2000
• Study Completion Date: Sep 1, 2001

Outcome Measures

Primary Outcome Measures

1. - percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment []

Secondary Outcome Measures

1. - percent change in lesion counts after ~2 and ~4 weeks []

2. - Global Severity Assessment []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• BioWest Therapeutics Inc

Investigators

• Study Director: Jim Pankovich, BioWest Therapeutics Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00211523
• Other Study ID Numbers: A99004
• First Posted: Sep 21, 2005
• Last Update Posted: Sep 21, 2005
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: acne; acne vulgaris; MBI 226; Propionibacterium acnes; lesion counts; lesions; inflammatory; non-inflammatory; topical
• Additional relevant MeSH terms: Acne Vulgaris; Omiganan pentahydrochloride

Study Results

No Results Posted as of Sep 21, 2005