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:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00211523
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211523

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

No publications provided

ClinicalTrials.gov Identifier: NCT00211523     History of Changes
Other Study ID Numbers: A99004
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Food and Drug Administration

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
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 17, 2014