Treatment of Moderate to Severe Acne Vulgaris in a Hispanic Population: A Post-Hoc Analysis of Efficacy and Tolerability of Clindamycin Phosphate 1.2%/Benzoyl Peroxide 2.5% Gel

April 2012 | Volume 11 | Issue 4 | Original Article | 455 | Copyright © 2012

Abstract

Background: Acne in Hispanics is an increasing problem, presenting unique challenges. Although combination therapy is now a standard of care in acne, concerns exist with the increased potential irritation and dryness in this population and the potential for hyperpigmentation. There is a paucity of clinical studies that evaluate the efficacy and tolerability of acne medications in Hispanics.
Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 458 Hispanic subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel, individual active ingredients and vehicle from two 12-week multicenter double-blind studies that enrolled 2813 subjects with moderate to severe acne.
Results: Median reductions in inflammatory lesions, noninflammatory, and total lesions (71.6%, 50.9% and 55.1%, respectively) were significantly greater with clindamycin phosphate 1.2%/BPO 2.5% gel versus the individual active ingredients and vehicle. Treatment success (35.6% "clear/almost clear") and patient satisfaction (83.2%) were also significantly greater than vehicle at week 12. Cutaneous tolerability was excellent with all mean scores less than or equal to 0.2 at week 12 (where 1=mild).
Conclusions: Overall efficacy and tolerability with clindamycin phosphate 1.2%/BPO 2.5% gel were better in the Hispanic population compared to the total study population. Hispanic acne subjects were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was excellent. J Drugs Dermatol.

J Drugs Dermatol. 2012;11(4):455-459.

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INTRODUCTION

Hispanics are the fastest growing minority group in the U.S.; growing by 43% in the last decade, surpass-ing 50 million and accounting for 1 in 4 people under age 18. In contrast with the anticipated relatively flat Caucasian growth rate of 1.5%, the projected growth rate in the Hispanic population is 22%. 1 Hispanics are racially, geographically, po- litically, culturally, and socioeconomically diverse and acne is reported as the most common dermatologic diagnosis seen in over 20% of this population. 2,3 Severity of acne, its sequelae such as propensity for hyperpigmentation after the acne re- solves, and approach to treatment can all vary. In a U.S. study, most of the Hispanic patients had papular lesions (74.5%), with a relatively high incidence of acne hyperpigmented macules (52.7%) and scarring (21.8%). 4

Postinflammatory hyperpigmentation (PIH) can be equally or more concerning than the acne that proceeds it and can be trig- gered by skin irritation independent of cause in addition to the acne itself. 5-7 It is best prevented with early intervention using combination therapy. 8 Careful use of more aggressive interven- tion may be necessary, even when the quality of acne is mild to moderate. Combining agents that target the different etiological factors of acne can help increase efficacy and response time. 9 There have been multiple clinical studies showing the efficacy of using two or three different anti-acne agents, such as benzoyl peroxide (BPO), a topical antibiotic, and a topical retinoid. 10 Despite the benefits of combination therapy, the potential for in - creased cutaneous irritation and PIH is a concern as Hispanics may

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