Conditions: Acne Vulgaris
Keywords: acne vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 378
Healthy volunteers: no

Brief summary:
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Adapalene/ BPO gel with Lymecycline capsules intervention 2: Adapalene/ BPO vehicle gel with Lymecycline capsules
Intervention descriptions: intervention 1: Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning intervention 2: Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Protocol document: