Conditions: Severe Acne Vulgaris
Keywords: Acne
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 459
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Detailed description:
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

Arms:
arm 1: Adapalene-BPO + Doxycyline arm 2: Vehicle + Doxycycline

Interventions: intervention 1: Adapalene BPO Gel associated with Doxycyline Hyclate intervention 2: Vehicle Gel associated with Doxycycline Hyclate
Intervention descriptions: intervention 1: Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks. intervention 2: Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.

Protocol document: