Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

This study has been completed.
Sponsor:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00211497
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 13, 2005
September 13, 2005
January 2003
Not Provided
- percent change from Baseline to Week 12 in inflammatory acne lesion counts
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Acne Vulgaris
  • Acne
  • Propionibacterium Acnes
Drug: MBI 226 Acne Solutions
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
September 2003
Not Provided

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00211497
A99005
Not Provided
Not Provided
BioWest Therapeutics Inc
Not Provided
Study Director: Jim Pankovich BioWest Therapeutics Inc
BioWest Therapeutics Inc
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP