Clinical Trial: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

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

Official Title: A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris

Brief Summary: The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its vehicle in the treatment of moderate-severe acne vulgaris.

Detailed Summary:
Sponsor: Braintree Laboratories

Current Primary Outcome: percent reduction of total acne lesion counts [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Investigator's Global Assessment [ Time Frame: 12 ]
  Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator.
• Change in serum chemistry [ Time Frame: 12 weeks ]

Original Secondary Outcome: Same as current

Information By: Braintree Laboratories

Dates:
Date Received: November 11, 2010
Date Started: November 2010
Date Completion:
Last Updated: September 27, 2012
Last Verified: September 2012