ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00211497A99005NCT00211497Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of AcneA 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 VulgarisBioWest Therapeutics IncIndustry
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.
CompletedJanuary 2003September 2003Phase 2InterventionalRandomizedParallel AssignmentTreatmentDouble- percent change from Baseline to Week 12 in inflammatory acne lesion countsSingle 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 countsMultiple 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 countsCategorical 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 12255Acne VulgarisAcnePropionibacterium AcnesDrugMBI 226 Acne Solutions
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
All12 YearsN/ANoJim PankovichStudy DirectorBioWest Therapeutics IncSeptember 2005September 13, 2005September 13, 2005September 21, 2005September 13, 2005September 13, 2005September 21, 2005acne vulgarisacnePropionibacterium acnestopicalinflammatorynon-inflammatorylesion countslesionsAcne VulgarisOmiganan pentahydrochloride