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

June 2017 | Volume 16 | Issue 6 | Original Article | 543 | Copyright © 2017

Leon H. Kircik MD

Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; Icahn School of Medicine at Mount Sinai, New York, NY

Abstract

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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INTRODUCTION

Acne vulgaris is a very common and chronic disease that typically requires maintenance treatment. The early use of aggressive combination therapy has the potential to improve treatment by producing greater and faster results, and simplifying disease management, leading to greater patient satisfaction and adherence with therapy. Maintenance therapy is often necessary because of the chronicity of acne lesions af- ter discontinuing a successful treatment regimen.1,2 By design, most clinical trials in acne focus on a 12-week treatment period. A fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel was shown to provide statistically significant greater efficacy than vehicle with a favourable safety and tolerability profile, following daily application over 12 weeks in patients with moderate-to-severe acne.3 Mean percent changes from baseline in inflammatory and noninflammatory lesions of 60.6% and 51.6% were achieved at week 12 (P3Our objective was to assess the maintenance effect of clindamycin-BP 3.75% gel in adult female patients with moderate acne who showed at least 50% improvement in total lesion count from baseline following 12 weeks of clindamycin-BP 3.75% gel treatment.

METHODS

Adult female patients aged 25 years or above with moderate acne (IGA=3) were enrolled. Patients were treated with clindamycin-BP 3.75% gel daily for 12 weeks. Patients who experienced at least a 50% reduction in total lesion count by week 12 continued to receive clindamycin-3.75BP% gel maintenance (once-daily) for another 12 weeks. Key efficacy and safety criteria included maintenance rate (patients maintaining their improvement in total lesion counts from week 12), lesion counts (total, inflammatory and non-inflammatory), global severity assessment (IGA), cutaneous tolerability and adverse events (AEs). Lesion counts were measured at week 4, 8, 12, 18, and 24. In addition, overall acne severity (IGA score) was assessed at

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