Conditions: Acne Vulgaris
Keywords: twice daily once daily CLDM 1%-BPO 3% gel Clindamycin (CLDM) benzoyl peroxide (BPO) inflammatory lesion non-inflammatory lesion acne vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 800
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin \[CLDM\] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide \[BPO\] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.

Detailed description:
Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions (open and closed comedones), including nasal lesions. The primary objectives are to demonstrate the superiority of GSK2585823 twice daily to CLDM twice daily in total lesion counts, and to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in total lesion counts. The secondary objectives are to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in inflammatory lesion counts, and to evaluate the efficacy of GSK2585823 once or twice daily compared with CLDM twice daily at each visit. A total of 800 subjects will be enrolled and randomly assigned to one of the groups.

Arms:
arm 1: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. arm 2: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime. arm 3: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime.

Interventions: intervention 1: GSK2585823(CLDM 1%-BPO 3% gel) intervention 2: CLDM 1% gel twice daily
Intervention descriptions: intervention 1: Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg intervention 2: Topical gel containing clindamycin 10 mg/1 g gel

Protocol document: