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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide

Criteria

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