Fixed Combination of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 3.75% Aqueous Gel: Long-Term Use in Adult Females With Moderate Acne Vulgaris.

OBJECTIVE: To evaluate long-term efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (Clindamycin-BP 3.75%) aqueous gel in adult female patients with moderate acne vulgaris.

METHODS: Total of 20 patients, 25-63 years of age (mean [SD], 38 ± 10) with moderate acne (IGA=3) were treated with Clindamycin-BP 3.75% once-daily for 12 weeks. Patients who experienced ≥50% reduction in total lesion count continued treatment for a further 12 weeks. Mean (SD) percent reduction in lesion counts from baseline were assessed at week 4, 8, 12, 18, and 24. In addition, patients who were 'clear' or 'almost clear' were reported at week 12 and 24. Cutaneous tolerability (erythema, dryness, peeling, pruritus, and burning) and oiliness was assessed at baseline and each study visit. Adverse events were assessed throughout the study.

RESULTS: Clindamycin-BP 3.75% demonstrated statistical significant improvement from baseline and between each visit. At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts was 70.6% and 58.6%, respectively. Two patients failed to experience ≥50% lesion reduction by week 12. At week 24, mean percent reductions in inflammatory and noninflammatory lesion counts were 93.8% and 90; 72% of patients were 'clear' or 'almost clear'. Overall the treatment was tolerable. There was one adverse event (sinus infection) that was not treatment-related.

CONCLUSIONS: Clindamycin-BP 3.75% gel demonstrates continued improvement in symptoms of moderate acne over 24 weeks, with good tolerability, demonstrating a clinical benefit of continued clindamycin-BP 3.75% gel as a maintenance therapy for acne in adult female patients.

J Drugs Dermatol. 2017;16(6):543-546.

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