Safety and Efficacy of Clindamycin Phosphate 1.2%-Benzoyl Peroxide 3% Fixed-Dose Combination Gel for the Treatment of Acne Vulgaris: A Phase 3, Multicenter, Randomized, Double-Blind, Active- and Vehicle-Controlled Study
December 2011 | Volume 10 | Issue 12 | Original Article | 1382 | Copyright © December 2011
Lawrence F. Eichenfielda MD and Alessandra B. Alió Sáenzb MD
aRady Children's Hospital and University of California, San Diego School of Medicine, San Diego, CA bStiefel, a GSK company, Research Triangle Park, NC
Abstract
Background: Topical fixed-combination therapy containing 1% clindamycin as 1.2% clindamycin phosphate (CLNP) and 3% benzoyl peroxide (BPO) is an effective treatment for acne vulgaris (acne).
Objectives: To demonstrate that the combination of 1.2% CLNP with lower strength BPO (CLNP 1.2%-BPO 3%) in a gel formulation is superior to each individual ingredient, CLNP 1.2% and BPO 3%, and vehicle gel.
Methods: A total of 1,319 patients with acne, aged 12 years or older, were enrolled and randomized (1:1:1:1) to receive CLNP 1.2%-BPO 3%, CLNP 1.2% gel, BPO 3% gel, or vehicle gel once-daily in a 12-week, multicenter, double-blind, parallel-group, vehicle-controlled study. Subjects were evaluated at baseline, weeks 2, 4, 8, and 12 or early termination. Assessment of efficacy was evaluated using a six-point Investigator's Static Global Assessment (ISGA) and Subject's Global Assessment (SGA) of acne severity and lesion counts (inflammatory, non-inflammatory, and total). Safety assessments included skin tolerability and adverse events (AEs).
Results: A greater proportion of subjects who used CLNP 1.2%-BPO 3% gel (39%) had a two grade improvement in ISGA from baseline to week 12 compared with CLNP 1.2% (25%; P<0.001), BPO 3% (30%; P=0.016), and vehicle (18%; P<0.001). CLNP 1.2%- BPO 3% was superior to CLNP 1.2% and vehicle alone in the absolute reduction from baseline to week 12 in all three lesion types (P<0.001 all pair-wise comparisons). CLNP 1.2%-BPO 3% was superior to BPO 3% alone in the absolute reduction from baseline to week 12 in inflammatory (P=0.015) and total (P=0.032) lesion counts. The incidence of product-related AEs was low and similar in all study groups (1% with CLNP 1.2%-BPO 3%, 2% with CLNP 1.2%, 2% with BPO 3%, and 2% with vehicle). Local tolerability assessments showed similar minimal changes from baseline to week 12 in all study groups.
Conclusion: CLNP 1.2%-BPO 3% gel provides superior efficacy to improve ISGA score and reduce inflammatory and total lesion counts compared with the individual active ingredients (CLNP 1.2% and BPO 3%) and vehicle, while maintaining a highly favorable safety and tolerability profile similar to BPO 3% alone.
J Drugs Dermatol. 2011;10(12):1382-1396.
INTRODUCTION
Acne vulgaris (acne) is a common dermatological disease seen typically in adolescence and young adulthood. It affects approximately 85 percent of individuals at some point in their lives, generally between 12 and 25 years of age.1 Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant.
Acne is a chronic inflammatory disease of the pilosebaceous unit that is characterized by the formation of comedones, papules and pustules. In severe acne, nodules, cysts and scarring are also present. The disease generally manifests on the face, chest, and back. The pathogenesis of acne is multifactorial, involving an increase in the production of sebum in the pilosebaceous unit, development of microcomedones and
