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.