Conditions: Acne Vulgaris Acne
Keywords: Acne Vulgaris Acne
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1649
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Detailed description:
CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Arms:
arm 1: CT Gel arm 2: Clindamycin Gel (clindamycin) arm 3: Tretinoin Gel (tretinoin) arm 4: Vehicle Gel

Interventions: intervention 1: CT Gel intervention 2: Clindamycin Gel (clindamycin ) intervention 3: Tretinoin Gel (tretinoin) intervention 4: Vehicle Gel
Intervention descriptions: intervention 1: Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks intervention 2: Clindamycin 1% gel applied topically once daily in the evening for 12 weeks intervention 3: Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks intervention 4: Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Protocol document: