A Long Term Study of GK530G in Subjects With Acne Vulgaris

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Interventions

  • Drug: GK530G

Arms, Groups and Cohorts

  • Experimental: GK530G
    • GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Percent Changes From Baseline in Total Lesion Counts
    • Time Frame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women at the age of 12 or older at the Screening visit. – Those with clinical diagnosis of acne vulgaris with more than 20 non-inflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin). Exclusion Criteria:

  • Those with more than two nodular acne lesions or any cyst. – Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne. – Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor

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