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

This study has been completed.
Sponsor:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00211497
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by BioWest Therapeutics 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
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc
  More Information

No publications provided

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

Keywords provided by BioWest Therapeutics Inc:
acne vulgaris
acne
Propionibacterium acnes
topical
 inflammatory
non-inflammatory
lesion counts
lesions

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 21, 2013