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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014