Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00211497 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris Acne Propionibacterium Acnes | Drug: MBI 226 Acne Solutions | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 255 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2003 |
Study Completion Date : | September 2003 |
- - percent change from Baseline to Week 12 in inflammatory acne lesion counts
- Single continuous endpoints:
- • Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
- • The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
- Multiple continuous endpoints:
- • Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
- • Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
- • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
- Categorical endpoints:
- • Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
- • PGSA absolute scores at Week 6 and Week 12
- • PGSA absolute scores over Baseline, Week 6 and Week 12

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211497
Study Director: | Jim Pankovich | BioWest Therapeutics Inc |
ClinicalTrials.gov Identifier: | NCT00211497 |
Other Study ID Numbers: |
A99005 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | September 21, 2005 |
Last Verified: | September 2005 |
acne vulgaris acne Propionibacterium acnes topical |
inflammatory non-inflammatory lesion counts lesions |
Acne Vulgaris Acneiform Eruptions Skin Diseases |
Sebaceous Gland Diseases Omiganan pentahydrochloride Anti-Infective Agents |