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