Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Adapalene
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1075
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Detailed description:
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Adapalene lotion 0.1% intervention 2: Adapalene Lotion Vehicle
Intervention descriptions: intervention 1: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks intervention 2: Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks

Protocol document: