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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211523
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
BioWest Therapeutics Inc
  Purpose
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 Intervention Phase
Acne Vulgaris Acne Propionibacterium Acnes Drug: MBI 226 Acne Solutions Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by BioWest Therapeutics Inc:

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

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

Estimated Enrollment: 75
Study Start Date: October 2000
Estimated Study Completion Date: September 2001
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT00211523


Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc
  More Information

ClinicalTrials.gov Identifier: NCT00211523     History of Changes
Other Study ID Numbers: A99004
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by BioWest Therapeutics Inc:
acne
acne vulgaris
MBI 226
Propionibacterium acnes
lesion counts
lesions
inflammatory
non-inflammatory
topical

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pharmaceutical Solutions
Antimicrobial Cationic Peptides
Anti-Infective Agents