DUAC® Early Onset Efficacy Study in Japanese Subjects
Status:
Completed
Trial end date:
2016-02-17
Target enrollment:
Participant gender:
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.