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

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. Identifier: NCT00211523
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Information provided by:
BioWest Therapeutics Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Acne Propionibacterium Acnes Drug: MBI 226 Acne Solutions Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2000
Study Completion Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Primary Outcome Measures :
  1. - percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment

Secondary Outcome Measures :
  1. - percent change in lesion counts after ~2 and ~4 weeks
  2. - Global Severity Assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00211523

Sponsors and Collaborators
BioWest Therapeutics Inc
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Study Director: Jim Pankovich BioWest Therapeutics Inc
Layout table for additonal information Identifier: NCT00211523    
Other Study ID Numbers: A99004
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005
Keywords provided by BioWest Therapeutics Inc:
acne vulgaris
MBI 226
Propionibacterium acnes
lesion counts
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Omiganan pentahydrochloride
Anti-Infective Agents