Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

- percent change from Baseline to Week 12 in inflammatory acne lesion counts

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acne Vulgaris
Acne
Propionibacterium Acnes

Intervention ^ICMJE

Drug: MBI 226 Acne Solutions

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

255

Completion Date

September 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00211497

Responsible Party

Study ID Numbers ^ICMJE

A99005

Study Sponsor ^ICMJE

MIGENIX Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jim Pankovich

MIGENIX Inc.

Information Provided By

MIGENIX Inc.

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP