NCT00211497
Completed
Phase 2
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
BioWest Therapeutics Inc0 sites255 target enrollmentJanuary 2003
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acne Vulgaris
- Sponsor
- BioWest Therapeutics Inc
- Enrollment
- 255
- Primary Endpoint
- - percent change from Baseline to Week 12 in inflammatory acne lesion counts
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
- percent change from Baseline to Week 12 in inflammatory acne lesion counts
Secondary Outcomes
- 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
Similar Trials
Completed
Phase 2
SB208 for the Treatment of Tinea PedisTinea PedisNCT02860052Novan, Inc.222
Recruiting
Phase 2
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-studyEpidermolysis Bullosa (EB)NCT06594393Xinnate AB32
Completed
Phase 2
A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia ParestheticaNCT06262607Clexio Biosciences Ltd.59
Completed
Phase 2
Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque PsoriasisPsoriasisNCT02785185Bausch Health Americas, Inc.150
Completed
Phase 2
A Study of VBP-245 in Pediatric Patients With Molluscum ContagiosumMolluscum ContagiosumNCT03077750Veloce BioPharma LLC110