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

Galderma

Status and phase

Completed

Phase 3

Conditions

Severe Acne Vulgaris

Treatments

Drug: Adapalene BPO Gel associated with Doxycyline Hyclate

Drug: Vehicle Gel associated with Doxycycline Hyclate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00688064

RD.03.SPR.29074

Details and patient eligibility

About

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.

Full 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)

Enrollment

459 patients

Sex

All

Ages

12 to 35 years old

Volunteers

No Healthy Volunteers

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.)