Acne, Acne Vulgaris, Propionibacterium Acnes
Conditions
Keywords
acne vulgaris, acne, Propionibacterium acnes, topical, inflammatory, non-inflammatory, lesion counts, lesions
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.
Interventions
Sponsors
BioWest Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - percent change from Baseline to Week 12 in inflammatory acne lesion counts | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 | — |
| Single continuous endpoints: | — |
| 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 | — |
| • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts | — |
Outcome results
None listed