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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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ClinicalTrials.gov Identifier: NCT00211497
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Sponsor:
Information provided by:
BioWest Therapeutics Inc

Study Description
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Brief 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.

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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. - percent change from Baseline to Week 12 in inflammatory acne lesion counts

Secondary Outcome Measures :
  1. Single continuous endpoints:
  2. • Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
  3. • The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
  4. Multiple continuous endpoints:
  5. • Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
  6. • Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
  7. • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
  8. Categorical endpoints:
  9. • Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
  10. • PGSA absolute scores at Week 6 and Week 12
  11. • PGSA absolute scores over Baseline, Week 6 and Week 12

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00211497


Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
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Study Director: Jim Pankovich BioWest Therapeutics Inc
More Information
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ClinicalTrials.gov Identifier: NCT00211497     History of Changes
Other Study ID Numbers: A99005
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
acne
Propionibacterium acnes
topical
 inflammatory
non-inflammatory
lesion counts
lesions

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
 Pharmaceutical Solutions
Omiganan pentahydrochloride
Anti-Infective Agents