Clinical Trial: Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

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

Official Title: A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Median percent reductions from Baseline in total lesion count (ITT-LOCF)



Original Primary Outcome: Percent Reduction in Total Lesion Counts [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Percent of Subjects With Adverse Events [ Time Frame: up to 12 weeks ]
    Adverse events which were observed in 5% or more patients with either group are listed.
  • Local Tolerability (Erythema) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline
  • Local Tolerability (Scaling) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline
  • Local Tolerability (Dryness) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline
  • Local Tolerability (Pruritus) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline
  • Local Tolerability (Stinging/Burning) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline


Original Secondary Outcome: Percent of Subjects With Adverse Events will be evaluated [ Time Frame: up to 12 weeks ]

Information By: Galderma R&D

Dates:
Date Received: February 20, 2014
Date Started: March 2014
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017