Clinical Trial: Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

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

Official Title: A Multicenter, Randomized, Double-blinded, Active-controlled Parallel Group Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acn

Brief Summary: This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.

Detailed Summary:
Sponsor: Galderma R&D

Current Primary Outcome: Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week12 ]

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 ]
• 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 [ 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