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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211497
• Other study ID #: A99005
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: January 2003
• Est. completion date: September 2003

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris
• Propionibacterium Acnes

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 from Baseline to Week 12 in inflammatory acne lesion counts
Secondary	Single continuous endpoints:
Secondary	• Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
Secondary	• The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
Secondary	Multiple continuous endpoints:
Secondary	• Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
Secondary	• Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
Secondary	• Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
Secondary	Categorical endpoints:
Secondary	• Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
Secondary	• PGSA absolute scores at Week 6 and Week 12
Secondary	• PGSA absolute scores over Baseline, Week 6 and Week 12