The efficacy and tolerability of a fixed combination clindamycin (1.2%) and benzoyl peroxide (3.75%) aqueous gel in patients with facial acne vulgaris: gender as a clinically relevant outcome variable.

OBJECTIVE

To investigate whether treatment differences exist in male and female patients with moderate to severe acne treated with clindamycin phosphate 1.2%/BP 3.75% gel or vehicle as monotherapy.

METHODS

A post hoc analysis comparing the efficacy and cutaneous tolerability in 498 male and female patients with moderate to severe acne receiving clindamycin phosphate 1.2%/BP 3.75% gel, or vehicle for 12 weeks.

RESULTS

The efficacy of clindamycin phosphate 1.2%/BP 3.75% gel was greater than vehicle (P>.001) in both genders. Within the clindamycin phosphate 1.2%/BP 3.75% gel group, the mean percent change from baseline in inflammatory and noninflammatory lesion counts was greater among females than males, as was the percentage of subjects who achieved a 2-grade reduction in the EGSS (P=.049).

LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients.

CONCLUSIONS

Clindamycin phosphate 1.2%/BP 3.75% gel provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile. It appears to be more effective in female patients.