A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Official Title: “A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris”

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Intervention(s) in this Clinical Trial

• Drug: Adapalene/Benzoyl Peroxide
  • Topical Gel, One application daily in the evening for 12 weeks
• Drug: Adapalene
  • Topical Gel,One application daily in the evening for 12 weeks
• Drug: Benzoyl Peroxide
  • Topical Gel, one application daily in the evening for 12 weeks
• Drug: Topical Gel Vehicle
  • Topical Gel Vehicle,one application daily in the evening for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Adapalene/Benzoyl Peroxide Topical Gel
• Active Comparator: 2
  • Adapalene Topical Gel
• Active Comparator: 3
  • Benzoyl Peroxide Topical Gel
• Placebo Comparator: 4
  • Topical Gel Vehicle

Primary Measures

• Success Rate on the Investigator's Global Assessment
  • Time Frame: at week 12
    Safety Issue?: No
• Changes in Inflammatory Lesion Counts
  • Time Frame: from Baseline to week 12
    Safety Issue?: No
• Changes in Noninflammatory Lesion Counts
  • Time Frame: from Baseline to week 12
    Safety Issue?: No

Secondary Measures

• Percent Change in Inflammatory Lesion Counts
  • Time Frame: at week 12
    Safety Issue?: No
• Percent Change in Noniflammatory Lesion Counts
  • Time Frame: at week 12
    Safety Issue?: No
• Percent Change in Total Lesion Counts
  • Time Frame: at week 12
    Safety Issue?: No

Inclusion Criteria:

• A clinical diagnosis of acne vulgaris with facial involvement.
• A minimum of 20 but not more than 50 Inflammatory lesions
• A minimum of 30 but not more than 100 Noninflammatory lesions
• A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion Criteria:

• More than one acne nodule or any acne cyst.
• Acne conglobata, acne fulminans, secondary acne, or severe acne.
• Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
• Underlying diseases that require the use of interfering topical or systemic therapy.
• Use of prohibited medications prior to the study unless appropriate washout period is documented
• Use of hormonal contraceptives solely for control of acne

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Galderma Industry

Overall Clinical Trial Officials and Contacts

Michael Graeber, MD Study Director Galderma  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00421993

Study ID Number: RD.06.SPR.18088

ClinicalTrials.gov Identifier: NCT00421993

Health Authority: United States: Food and Drug Administration