Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

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.

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Key information

Conditions

Acne Vulgaris Acne Acneiform Eruptions Propionibacterium Acnes Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females, ages 13 and up, exhibiting high levels of facial P. acnes
Presence of inflammatory and non-inflammatory lesions

Exclusion criteria

Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.)
Active facial cysts

Treatment and study plan

MBI 226 Acne Solutions

Drug

Primary outcomes

- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment

Secondary outcomes

- percent change in lesion counts after ~2 and ~4 weeks
- Global Severity Assessment

Sponsors and collaborators

Lead sponsor

BioWest Therapeutics Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2000
Study completion: 2001
First posted: Sep 21, 2005
Registry last updated: Sep 21, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed