Efficacy and safety of clindamycin-tretinoin gel versus clindamycin or tretinoin alone in acne vulgaris: A randomized, double-blind, vehicle-controlled study

摘要

Background: Topical combination therapy containing a retinoid and an antimicrobial is an effective treatment for acne vulgaris. Objective: To evaluate the efficacy and safety of a new topical formulation containing clindamycin phosphate 1.2% and tretinoin 0.025% solubilized in an aqueous-based gel (CT gel). Methods: 1,649 participants were randomized 2:2:2:1 to 12 weeks of double-blind treatment with CT gel, clindamycin, tretinoin, or vehicle gel administered once daily. Results: Significantly more participants achieved 2-grade or greater improvement on the Investigator's Static Global Assessment score with CT gel versus clindamycin, tretinoin, or vehicle gel. CT gel produced a significantly greater reduction in absolute number of total lesions versus all other treatment groups, in total and noninflammatory lesions versus clindamycin, and in total and inflammatory lesions versus tretinoin. Local tolerability was similar to that of tretinoin alone; signs and symptoms of irritation were most notable at week 2. There were no more adverse events with CT gel than with tretinoin gel. Conclusion: CT gel is more effective than clindamycin or tretinoin monotherapy, with a safety and tolerability profile similar to that of tretinoin.