Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
September 13, 2005 updated by: BioWest Therapeutics Inc
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
255
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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- percent change from Baseline to Week 12 in inflammatory acne lesion counts
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Secondary Outcome Measures
Outcome Measure |
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Single continuous endpoints:
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• Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
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• The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
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Multiple continuous endpoints:
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• Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
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• Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
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• Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
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Categorical endpoints:
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• Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
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• PGSA absolute scores at Week 6 and Week 12
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• PGSA absolute scores over Baseline, Week 6 and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jim Pankovich, BioWest Therapeutics Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion
September 1, 2003
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
September 21, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A99005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.