Conditions: Acne Vulgaris
Keywords: azelaic acid Clindamycin Benzoyl peroxide Acne vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: no

Brief summary:
This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.

Detailed description:

Arms:
arm 1: A total of 110 subjects will receive clindamycin + BPO once daily in the evening for 12 weeks as per the randomization schedule. arm 2: A total of 110 subjects will receive azelaic acid twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.

Interventions: intervention 1: Clindamycin + BPO intervention 2: Azelaic acid
Intervention descriptions: intervention 1: Gel containing 1.2% clindamycin and 3% BPO for once daily application intervention 2: Cream containing 20% azelaic acid for twice daily application

Protocol document: