The Efficacy and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Patients With Facial Acne Vulgaris: Gender as a Clinically Relevant Outcome Variable

April 2015 | Volume 14 | Issue 4 | Original Article | 381 | Copyright © April 2015


Julie C. Harper MD

The Dermatology and Skin Care Center of Birmingham, Birmingham, AL

Abstract
OBJECTIVE: To investigate whether treatment differences exist in male and female patients with moderate to severe acne treated with clindamycin phosphate 1.2%/BP 3.75% gel or vehicle as monotherapy.
METHODS: A post hoc analysis comparing the efficacy and cutaneous tolerability in 498 male and female patients with moderate to severe acne receiving clindamycin phosphate 1.2%/BP 3.75% gel, or vehicle for 12 weeks.
RESULTS: The efficacy of clindamycin phosphate 1.2%/BP 3.75% gel was greater than vehicle (P>.001) in both genders. Within the clindamycin phosphate 1.2%/BP 3.75% gel group, the mean percent change from baseline in inflammatory and noninflammatory lesion counts was greater among females than males, as was the percentage of subjects who achieved a 2-grade reduction in the EGSS (P=.049).
LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients.
CONCLUSIONS: Clindamycin phosphate 1.2%/BP 3.75% gel provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile. It appears to be more effective in female patients.

J Drugs Dermatol. 2015;14(4):381-384.

INTRODUCTION

There has been increased interest in possible gender differences in females and males when it comes to acne vulgaris and its treatment.1 Female acne patients have been shown to report worse quality of life than male patients.2 Nodulocystic acne is more prevalent in adolescent male patients; 3 while acne on the lower face and jawline, and the clinical cyclical flaring of lesions may be associated with hormonally medicated acne in females.4
Evidence now suggests that there may be gender-based differences in response to acne treatment. A study with dapsone 5% gel suggested that females experienced a significantly greater reduction in acne lesions compared to male acne patients after 12 weeks treatment. There were no gender difference in the low incidence of adverse events (AEs) reported.5 A post hoc analysis reported at the same time with clindamycin phosphate 1.2%/BP 2.5% gel also looked at gender differences, as well as stratifying by age.6 Here the net reduction in lesion counts (active minus vehicle) was much greater in the adolescent population; and treatment success favored older males and adolescent females.6
Recently, efficacy and tolerability data on a new fixed combination product, clindamycin phosphate 1.2%/BP 3.75% gel, was reported.7 A post hoc analysis of efficacy and cutaneous tolerability was conducted to examine any differences between gender in those moderate to severe acne subjects treated with clindamycin phosphate 1.2%/BP 3.75% gel or vehicle.

METHODS

Study Design

A total of 498 patients with moderate to severe acne vulgaris were randomized (1:1) to receive clindamycin phosphate 1.2%/ BP 3.75% gel or vehicle in a multicenter, double-blind, vehiclecontrolled, 12-week, 2-arm study. Studies were conducted in accordance with the Declaration of Helsinki and Good Clinical Practices and in compliance with local regulatory requirements. All patients provided written informed consent before entering the study. Subjects were stratified by severity of acne (Evaluator’s Global Severity Score [EGSS], ranging from 0 [clear] to 5 [very severe]). They were dichotomized into a moderate (EGSS of 3) and a severe acne group (EGSS of 4).
The post hoc analysis compared data between clindamycin phosphate 1.2%/BP 3.75% gel and vehicle in male and female subjects.

Study Population

Patients included males and females of any race or ethnicity with moderate to severe acne, presenting with 20 to 40 inflammatory lesions (papules, pustules, and nodules), 20 to
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