Conditions: Acne Vulgaris
Keywords: Clindamycin Gel Benzoyl Peroxide Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 350
Healthy volunteers: no

Brief summary:
This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene \[ADA\] and clindamycin \[CLDM\])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.

Detailed description:
Duac® is a registered trademark of Stiefel Laboratories, Inc., a GSK company. Duac® marketed in Japan is CLDM 1%-benzoyl peroxide 3% combination gel.

Arms:
arm 1: Subjects will use Duac® fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks. arm 2: Subjects will use combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and subjects will also apply CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel should apply subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel should be applied to ILs only.

Interventions: intervention 1: Duac® fixed dose combination gel intervention 2: ADA 0.1% gel intervention 3: CLDM 1% gel
Intervention descriptions: intervention 1: Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%. intervention 2: ADA 0.1% gel containing 0.1% of adapalene. intervention 3: CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).

Protocol document: