Clinical Trial: A Long Term Study of GK530G in Subjects With Acne Vulgaris

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

Official Title: A Long Term Study of GK530G in Subjects With Acne Vulgaris

Brief Summary: This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.

Detailed Summary:
Sponsor: Galderma R&D

Current Primary Outcome:

  • Local Tolerability (Erythema) [ Time Frame: 12 monhths ]
    Highest severity of Local tolerability scores worth than base line
  • Local Tolerability (Scaling) [ Time Frame: 12 months ]
    Highest severity of Local tolerability scores worth than base line
  • Local Tolerability (Dryness) [ Time Frame: 12 months ]
    Highest Severity of Local Tolerability Scores Worse Than Baseline
  • Local Tolerability (Pruritus) [ Time Frame: 12 months ]
    Highest Severity of Local Tolerability Scores Worse Than Baseline
  • Local Tolerability (Stinging/Burning) [ Time Frame: 12 months ]
    Highest Severity of Local Tolerability Scores Worse Than Baseline


Original Primary Outcome: Safety criteria [ Time Frame: 12 monhths ]

The safety evaluation consists of local tolerability assessment, physical examination, vital sign recording, laboratory tests (hematology, blood chemistries, and urinalysis), adverse events (AEs) recording.


Current Secondary Outcome: Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12 ]

Original Secondary Outcome:

Information By: Galderma R&D

Dates:
Date Received: July 25, 2013
Date Started: May 2013
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017