Clinical Trial: A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment

Brief Summary: The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Detailed Summary: Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.
Sponsor: AndroScience Corp

Current Primary Outcome: Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.


Original Primary Outcome: Acne lesion counts and Investigator's Global Assessment (IGA) [ Time Frame: 12 weeks ]

Current Secondary Outcome: Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne:

0 No acne lesions.

  1. Rare non-inflammatory lesions.
  2. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.
  3. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.
  4. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.
  5. Highly inflammatory lesions, multiple nodulo-cystic lesions.


Original Secondary Outcome:

Information By: AndroScience Corp

Dates:
Date Received: August 31, 2007
Date Started: August 2007
Date Completion:
Last Updated: November 16, 2011
Last Verified: November 2011