Clindamycin 1.2% Tretinoin 0.025% Gel versus Clindamycin Gel Treatment in Acne Patients: A Focus on Fitzpatrick Skin Types.

Background: Acne vulgaris affects individuals of all races and ethnicities. Understanding the safety and efficacy of topical agents benefits the practicing clinician when treating patients with skin of color.

Purpose: To report observations in acne patients representing all six Fitzpatrick skin types based on a Phase 3 study that evaluated the efficacy and safety of a clindamycin phosphate 1.2% tretinoin 0.025% gel versus a clindamycin phosphate 1.2% gel alone.

Methods: The two treatments were compared in a randomized, double-blind, multicenter, parallel, 12-week study employing a total of 2,010 patients with moderate-to-severe acne. Primary efficacy endpoints were 1) treatment success defined as percentage of patients who were clear or almost clear or achieved at least a 2-grade improvement in Evaluators Global Severity Scores at Week 12 and 2) percent change from baseline versus 12-week scores for noninflamed, inflamed, and total lesions.

Results: The 12-week, 37.8-percent Evaluators Global Severity Scores treatment success for clindamycin phosphate 1.2% tretinoin 0.025% gel was greater than the 31.7 percent observed for clindamycin phosphate 1.2% gel alone (P = 0.002). Percent changes from baseline versus 12-week scores for noninflamed, inflamed, and total lesions obtained with clindamycin phosphate 1.2% tretinoin 0.025% gel (49.8, 60.9, and 54.5%, respectively) were significantly greater than those observed for clindamycin phosphate 1.2% gel alone (41.3, 54.8, and 46.9%, respectively); all comparisons P<0.001.

Conclusion: Use of clindamycin phosphate 1.2% tretinoin 0.025% gel resulted in greater percent reductions of Evaluators Global Severity Scores treatment success scores and acne lesions in patients with all six Fitzpatrick skin types combined than clindamycin phosphate 1.2% gel alone. Both products were well tolerated, with no hypo- or hyperpigmentation noted. Side effects observed were similar to those previously reported for the individual ingredients.