Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne - Full Text View

Purpose

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.

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

MedlinePlus related topics:

Acne

ChemIDplus related topics:

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:	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

Further study details as provided by MIGENIX Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	75
Study Start Date:	October 2000
Estimated Study Completion Date:	September 2001

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211523

Sponsors and Collaborators

MIGENIX Inc.

Investigators


Study Director:	Jim Pankovich	MIGENIX Inc.

More Information

Study ID Numbers:	A99004
First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00211523
Health Authority:	United States: Food and Drug Administration

Keywords provided by MIGENIX Inc.:

acne

acne vulgaris

MBI 226

Propionibacterium acnes

lesion counts

lesions

inflammatory

non-inflammatory

topical

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 October 03, 2008

Sponsored by:	MIGENIX Inc.
Information provided by:	MIGENIX Inc.
ClinicalTrials.gov Identifier:	NCT00211523