Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne
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
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2000
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedSeptember 21, 2005
September 1, 2005
September 13, 2005
September 13, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment
Secondary Outcomes (2)
- percent change in lesion counts after ~2 and ~4 weeks
- Global Severity Assessment
Interventions
Eligibility Criteria
You may qualify if:
- Males and females, ages 13 and up, exhibiting high levels of facial P. acnes
- Presence of inflammatory and non-inflammatory lesions
You may not qualify if:
- Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.)
- Active facial cysts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jim Pankovich
BioWest Therapeutics Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
October 1, 2000
Study Completion
September 1, 2001
Last Updated
September 21, 2005
Record last verified: 2005-09