ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

This study has been completed.

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   

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:   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
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 September 05, 2008




Links to all studies - primarily for crawlers