Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel for the Treatment of Acne Vulgaris: Which Patients are Most Likely to Benefit the Most?

Clindamycin phosphate 1.2%/tretinoin 0.025% gel is a topical combination formulation used once daily for the treatment of acne vulgaris, with approval in the United States for patients >12 years of age. Three 12-week, randomized, vehicle-controlled, pivotal trials included > 1,800 actively treated subjects. In addition, an open-label, 52-week study was also completed with 442 subjects enrolled. The skin tolerability, safety, and efficacy of clindamycin phosphate 1.2%/tretinoin 0.025% gel applied once daily is well-established based on data from pivotal studies and analyses in other subsequent publications including from pooled analysis of results from 4,550 subjects. This article discusses results from the pivotal 12-week, Phase 3 studies of clindamycin phosphate 1.2%/tretinoin 0.025% gel applied once daily in 845 subjects with mild, moderate, or severe facial acne vulgaris and differentiates patterns of therapeutic response using study endpoint successes defined as clear, almost clear, or at least a 2-grade improvement in the AV severity rating.

RCT Entities:   Population Interventions Outcomes