Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

This study has been completed.
Sponsor:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00211523
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 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: 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

Resource links provided by NLM:


Further study details as provided by BioWest Therapeutics 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
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: NCT00211523

Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211523     History of Changes
Other Study ID Numbers: A99004
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
acne vulgaris
MBI 226
Propionibacterium acnes
lesion counts
lesions
inflammatory
non-inflammatory
topical

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014