Moderate to Severe Acne in Adolescents With Skin of Color: Benefits of a Fixed Combination Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5% Aqueous Gel

July 2012 | Volume 11 | Issue 7 | Original Article | 818 | Copyright © 2012

Abstract

Objective: Acne is common in adolescents and especially difficult to manage in people with color. A fixed combination of clindamycin phosphate and benzoyl peroxide (BPO) (clindamycin phosphate 1.2%/BPO 2.5% gel) was evaluated to determine its utility in treating moderate to severe acne in adolescents with skin of color.
Methods: Three hundred thirty-seven adolescent acne subjects (aged 12 to <18 years) with skin of color were evaluated from 2 multicenter, double-blind studies. Subjects were randomized to receive clindamycin phosphate 1.2%/BPO 2.5% gel or vehicle, once daily for 12 weeks. Efficacy and tolerability were evaluated. Data were compared with an adolescent (A) and skin of color (B) cohort from the same pivotal study enrolling 2,813 subjects.
Results: Superior mean percent reductions in inflammatory, noninflammatory, and total lesion counts were observed in subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel compared to vehicle. At week 12, clindamycin phosphate 1.2%/BPO 2.5% gel showed similar lesion reduction compared to groups A and B (P<0.001). Treatment success with clindamycin phosphate 1.2%/BPO 2.5% gel, assessed by investigator and subject, was superior to vehicle and comparable to that seen in groups A and B (P<0.001). Clindamycin phosphate 1.2%/ BPO 2.5% gel was associated with a low incidence of treatment-related AEs and a favorable cutaneous tolerability profile.
Conclusions: Clindamycin phosphate 1.2%/BPO 2.5% gel has been shown to be effective, safe, and well tolerated in moderate to severe acne in adolescents with skin of color.

J Drugs Dermatol. 2012;11(7):818-824.

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INTRODUCTION

Acne vulgaris is a very common skin disease that affects almost all individuals by the time they reach adulthood. It may appear in children as young as 8 to 10 years of age, but becomes more common and severe in adolescents from 12 to 17 years of age. In boys, the prevalence has been estimated at 81% to 95%, compared to 79% to 82% in girls.1,2

Acne may cause significant scarring, as well as significant psychological and social impacts in adolescents.1,3 Studies have linked acne to anxiety, depression, social isolation, interpersonal difficulties, lower self-esteem, dissatisfaction with facial appearance, and fewer employment opportunities.3,4

Successful acne management includes targeting multiple pathogenic factors, treatment regimens providing sustained efficacy with minimal side-effects, maximizing adherence, avoiding bacterial resistance, and comprehensive patient education.5,6 However, complicating the clinical picture is the need to be aware of variations in skin color, culture, and the attitudes of both patients and their parents.7 For example, several structural and functional differences exist in people of color (Fitzpatrick Score IV to VI), many of whom have important clinical implications for disease and aesthetics and response to treatment.8 In addition, for many cultures, smooth, flawless skin (free from scars or pigment abnormalities) is considered particularly attractive and desirable.8

People of color are the fastest-growing population segment in the United States. By 2050, census estimates suggest that this diverse cross-section of ethnicities, which includes Hispanics, African Americans, Asians, and other non-Caucasians, will account for half of the population.9 Acne has been identified as the most common skin problem in African-Americans and Hispanics and the second most common skin problem in Asians. Studies have reported an overall prevalence as high as 29% in private dermatology practices comprising predominantly African- American patients.10

There is a paucity of clinical studies that evaluate not only the safety and efficacy of acne medications in skin of color but also how the disease process manifests itself differently in this patient group. Given the high incidence of adolescent acne, it is interesting that we could find no clinical data on the treatment of acne in adolescents with skin of color.

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