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NCT00211523 Clinical Trial

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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00211523
Other study ID # A99004
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated September 13, 2005
Start date October 2000
Est. completion date September 2001

Study information
Verified date September 2005
Source BioWest Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date September 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• MBI 226 Acne Solutions

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BioWest Therapeutics Inc

Outcome
Type Measure Description Time frame Safety issue
Primary - percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment
Secondary - percent change in lesion counts after ~2 and ~4 weeks
Secondary - Global Severity Assessment
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