Conditions: Acne Vulgaris
Keywords: Acne vulgaris Adapalene Benzoyl Peroxide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1668
Healthy volunteers: no

Brief summary:
This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were 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 participant should remain the same during the study.

The primary objective was 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: Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. arm 2: Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. arm 3: Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. arm 4: Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Interventions: intervention 1: Adapalene/Benzoyl Peroxide intervention 2: Adapalene Gel, 0.1% intervention 3: Benzoyl Peroxide Gel 2.5% intervention 4: Gel Vehicle
Intervention descriptions: intervention 1: Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. intervention 2: 0.1% of adapalene gel topically daily in the evening for 12 Weeks. intervention 3: 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. intervention 4: Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Protocol document: