Clinical Trial: Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2, Randomized, Multicenter, Double-Blind, Active and Vehicle Controlled Parallel-group Study Evaluating the Efficacy, Safety, and Tolerability of Products S6G5T-3 and S6G5T-1 for the Treatment

Brief Summary: The purpose of this study is to evaluate the superiority in efficacy and assess safety and tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active components or the vehicle for the treatment of acne.

Detailed Summary:
Sponsor: Sol-Gel Technologies, Ltd.

Current Primary Outcome:

• Investigator's Global Assessment (IGA) [ Time Frame: week 12 ]
  Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12
• Absolute change in lesion count (separately for inflammatory and non-inflammatory) [ Time Frame: baseline and week 12 ]
  Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Percentage change from Baseline in lesion count on the face at Week 12 [ Time Frame: Baseline and week 12 ]
  Percentage change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
• assessments of IGA at each time point [ Time Frame: baseline, week 4, 8 ]
  Supportive efficacy variables are the assessments of IGA percentage change at each time point during the treatment period, namely at Weeks 4, and 8.

Original Secondary Outcome: Same as current

Information By: Sol-Gel Technologies, Ltd.

Dates:
Date Received: January 11, 2016
Date Started: May 2016
Date Completion: July 2017
Last Updated: April 25, 2017
Last Verified: September 2016