Conditions: Acne Vulgaris
Keywords: Acne vulgaris Adapalene Benzoyl Peroxide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1670
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Adapalene/Benzoyl Peroxide Topical Gel arm 2: Adapalene Topical Gel arm 3: Benzoyl Peroxide Topical Gel arm 4: Topical Gel Vehicle

Interventions: intervention 1: Adapalene/Benzoyl Peroxide intervention 2: Adapalene intervention 3: Benzoyl Peroxide intervention 4: Topical Gel Vehicle
Intervention descriptions: intervention 1: Topical Gel, One application daily in the evening for 12 weeks intervention 2: Topical Gel,One application daily in the evening for 12 weeks intervention 3: Topical Gel, one application daily in the evening for 12 weeks intervention 4: Topical Gel Vehicle,one application daily in the evening for 12 weeks

Protocol document: