The Efficacy and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Adult Female Patients with Facial Acne Vulgaris.

OBJECTIVE

To investigate the efficacy and tolerability of clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel or vehicle monotherapy in adult female acne patients.

METHODS

A post hoc analysis in 72 adult female patients (aged ≥25 years) with moderate-to-severe acne receiving clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel or vehicle for 12 weeks.

RESULTS

The efficacy of clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel was significantly greater than vehicle. The mean percent change from baseline in inflammatory and noninflammatory lesion counts and the percentage of patients who achieved a 2-grade reduction in the Evaluator's Global Severity Score was 68.7%, 60.4, and 52.7 percent, respectively (P=0.019, 0.020 and 0.074 versus vehicle). In addition, 44 percent of patients reported their acne to be "clear" or "almost clear" at Week 12 (P=0.026 versus vehicle). No substantive differences were seen in cutaneous tolerability among treatment groups, and no patients discontinued treatment because of adverse events.

LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients, and this study was not set up specifically to investigate the treatment of adult female acne.

CONCLUSION

Clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel provides statistically significant greater efficacy than vehicle in treating acne in adult female patients and has a favorable safety and tolerability profile.