Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Overview

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Full Title of Study: “A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris”

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 2008

Detailed Description

Same as above.

Interventions

  • Drug: adapalene gel, 0.3%
    • Applied once daily at bedtime
  • Drug: clindamycin/benzoyl peroxide gel
    • Applied once daily in the morning

Arms, Groups and Cohorts

  • Experimental: Study Treatment
    • adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning

Clinical Trial Outcome Measures

Primary Measures

  • Percent Change From Baseline in Total Lesion Counts
    • Time Frame: 6 and 12 weeks

Secondary Measures

  • Global Severity Assessment Success
    • Time Frame: 6 and 12 weeks
    • Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
  • Global Assessment of Improvement From Baseline
    • Time Frame: 12 weeks
  • Worst Post Baseline Tolerability Assessment – Erythema
    • Time Frame: 12 weeks
    • Please Note: “Tolerability Assessments” were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
  • Worst Post Baseline Tolerability Assessment – Scaling
    • Time Frame: 12 weeks
    • Please Note: “Tolerability Assessments” were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
  • Worst Post Baseline Tolerability Assessment – Dryness
    • Time Frame: 12 weeks
    • Please Note: “Tolerability Assessments” were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
  • Worst Post Baseline Tolerability Assessment – Burning/Stinging
    • Time Frame: 12 weeks
    • Please Note: “Tolerability Assessments” were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Participating in This Clinical Trial

Inclusion Criteria

1. Subjects with a minimum of 20 inflammatory lesions on the face; 2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose; 3. Subject has a Global Severity Assessment Exclusion Criteria:

1. Subjects with more than three nodulo-cystic lesions

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ron W Gottschalk, MD, Study Director, Galderma R&D

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