Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Adapalene Benzoyl Peroxide
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 452
Healthy volunteers: no

Brief summary:
This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

Detailed description:

Arms:
arm 1: Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.

Interventions: intervention 1: Adapalene/Benzoyl Peroxide
Intervention descriptions: intervention 1: Adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.

Protocol document: