Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.

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.

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)

Inclusion Criteria:

• Male or female Subjects of any race, aged 12 to 35 years inclusive
• Subjects with severe facial acne (global severity score of 4)
• Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
• Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

• Subjects with more than 3 nodules or cysts on the face,
• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)