Clinical Trial: P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of <
Brief Summary: This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
Detailed Summary:
Sponsor: Novan, Inc.
Current Primary Outcome:
- Absolute change in inflammatory lesion counts [ Time Frame: 12 weeks ]
- Absolute change in non-inflammatory lesion counts [ Time Frame: 12 weeks ]
- Proportion of success according to the dichotomized Investigator Global Assessment [IGA] at end of treatment [ Time Frame: 12 weeks ]Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percent change in inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
- Percent change in non-inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
- Median time to improvement [ Time Frame: Baseline through Week 12 ]
Original Secondary Outcome: Same as current
Information By: Novan, Inc.
Dates:
Date Received: September 10, 2014
Date Started: November 2014
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017