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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00211497 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
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Scientific title:
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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 |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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255 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00211497 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Contacts
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Name:
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Jim Pankovich |
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Address:
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Telephone:
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Email:
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Affiliation:
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BioWest Therapeutics Inc |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acne
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Acne Vulgaris
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Propionibacterium Acnes
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Intervention(s)
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Drug: MBI 226 Acne Solutions
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Primary Outcome(s)
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- percent change from Baseline to Week 12 in inflammatory acne lesion counts
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Secondary Outcome(s)
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• Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
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• Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
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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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• 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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• The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
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Categorical endpoints:
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Multiple continuous endpoints:
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Single continuous endpoints:
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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