Clinical Trial: A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Brief Summary: The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
Detailed Summary:
Sponsor: Dermira, Inc.
Current Primary Outcome:
- Mean absolute change in acne lesion counts (inflammatory and non-inflammatory lesions) from baseline to Week 12 [ Time Frame: Week 12 ]
- Proportion of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 [ Time Frame: Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percent change in acne lesion counts (inflammatory and non-inflammatory lesions) from baseline to Week 12 [ Time Frame: Week 12 ]
- Proportion of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 [ Time Frame: Week 12 ]
Original Secondary Outcome: Same as current
Information By: Dermira, Inc.
Dates:
Date Received: March 3, 2017
Date Started: February 6, 2017
Date Completion: March 2018
Last Updated: April 25, 2017
Last Verified: April 2017
