An Aqueous Gel Fixed Combination of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 3.75% for the Once-Daily Treatment of Moderate to Severe Acne Vulgaris

September 2014 | Volume 13 | Issue 9 | Original Article | 1083 | Copyright © September 2014

David M. Pariser MD,a Phoebe Rich MD,b Fran E. Cook-Bolden MD,c and Andrew Korotzer PhDd

aVirginia Clinical Research, Inc., Norfolk, VA
bOregon Dermatology and Research Center, Portland, OR
cSkin Specialty Dermatology, New York, NY
dValeant Pharmaceuticals, Bridgewater, NJ

Abstract
OBJECTIVE: To evaluate efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in moderate to severe acne vulgaris.
METHODS: A total of 498 patients, 12-40 years of age, were randomized to receive clindamycin-BP 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts, Evaluator Global Severity Scores (EGSS) and subject self-assessment (SSA). In addition, patients completed a patient satisfaction survey (PSS), acne-specific QoL questionnaire, and assessed their facial skin for shininess/oiliness.
RESULTS: Clindamycin-BP 3.75% demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Clindamycin-BP 3.75% showed greater efficacy relative to vehicle in assessments of skin oiliness, SSA and PSS. No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycin-BP 3.75% because of adverse events.
LIMITATIONS: Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients.
CONCLUSIONS: Clindamycin-BP 3.75% provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile.

J Drugs Dermatol. 2014;13(9):1083-1089.

INTRODUCTION

Combination therapy for acne, simultaneously targeting multiple pathogenic factors is now commonplace,1 and many studies have shown that the combination of clindamycin 1% with benzoyl peroxide (BP) 5% is superior to each individual active ingredient. As a result, fixed combination products of clindamycin 1% and BP 5% have seen extensive use for the treatment of acne vulgaris.2-4 Although these products are very effective, dryness and irritation from the BP component are still limiting side effects in some patients.5
Consequently, a fixed-dose, once-daily combination product containing clindamycin phosphate 1.2% (equivalent to 1% clindamycin) and a low concentration (2.5%) of BP (clindamycin- BP 2.5%) was developed to effectively treat both the inflammatory and non-inflammatory lesions of acne vulgaris, while minimizing the potential for skin irritation.6
Clindamycin-BP 2.5% is an alcohol-free aqueous gel with a humectant and solubilizing properties that may enhance both delivery and bioavailability of the micronized BP and clindamycin phosphate into the pilosebaceous unit. A combination of lower BP concentration and this formulation provided a fixed combination product shown to be effective and well tolerated in moderate to severe acne.6
A post-hoc analysis showed greater efficacy in moderate acne patients compared to severe patients.7 It was postulated that BP concentrations might be increased using the same formulation to provide greater effectiveness in those moderately severe acne patients, without significantly impacting safety and tolerability. This article reports the findings of a well-controlled trial of this higher BP strength formulation.

METHODS

Study Design

The study received approval before patient enrollment from the appropriate institutional review board for each center. It was conducted in accordance with the Declaration of Helsinki and Good Clinical Practices (GCP) and in compliance with local regulatory requirements. All patients provided written informed consent before entering the study.
This was a multicenter, randomized, double-blind, vehicle-controlled, parallel group study in 498 patients with moderate to