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

Sponsored by:	MIGENIX Inc.
Information provided by:	MIGENIX Inc.
ClinicalTrials.gov Identifier:	NCT00211497

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris Acne Propionibacterium Acnes	Drug: MBI 226 Acne Solutions	Phase II

MedlinePlus related topics: Acne

Drug Information available for: MBI-226 Omiganan pentahydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by MIGENIX Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	255
Study Start Date:	January 2003
Estimated Study Completion Date:	September 2003

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211497

Sponsors and Collaborators

MIGENIX Inc.

Investigators

Study Director:

Jim Pankovich

MIGENIX Inc.

More Information

Study ID Numbers:	A99005
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00211497
Health Authority:	United States: Food and Drug Administration

Keywords provided by MIGENIX Inc.:

acne vulgaris
acne
Propionibacterium acnes
topical

inflammatory
non-inflammatory
lesion counts
lesions

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies

Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Acneiform Eruptions

ClinicalTrials.gov processed this record on January 16, 2009