Journal of Clinical and Aesthetic Dermatology

JUN 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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36 JCAD journal of clinical and aesthetic dermatology June 2017 • Volume 10 • Number 6 H Background: Acne vulgaris (acne) is highly prevalent in the Hispanic population as it is in other racial/ethnic groups. While nuances in the presentation, quality-of-life impact, and approach to therapy of acne have been reported in various racial ethnic groups and skin types, data on the Hispanic population are limited, and yet they are the fastest growing population in the United States. Potential for irritation, dryness, and pigmentary alteration (due to acne and/or treatment) are key concerns in the management of acne in Hispanic populations. Evaluation of the efficacy and tolerability of topical therapies in this growing segment of the population is therefore important. Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 136 Hispanic subjects receiving clindamycin phosphate 1.2%/benzoyl peroxide (BP) 3.75% gel or vehicle from a 12-week, multicenter, double-blind study of 498 subjects with moderate-to-severe acne. Data was compared to that seen in the non-Hispanic population in the Phase 3 study. Results: Mean reductions in inflammatory and noninflammatory lesions (63.6% and 54.3%, respectively) were significantly greater with [Abstract continued on next page] A B S t r A C t P O S t P H O C A N A L Y S I S Treatment of Moderate-to-severe Acne Vulgaris in a Hispanic Population: A Post-hoc Analysis of the Efficacy and Tolerability of Clindamycin 1.2%/ Benzoyl Peroxide 3.75% Gel a ANDREW F. ALEXIS, MD, MPH; b FRAN COOK-BOLDEN, MD; c TINA LIN, PHARMD a Department of Dermatology, Mount Sinai St. Luke's and Mount Sinai West, New York, New York; b Skin Specialty Dermatology and Department of Dermatology, Mount Sinai Health Systems, New York, New York; c Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey HISPANICS ARE RACIALLY, geographically, politically, culturally, and socioeconomically diverse. They are the fastest growing population in the United States, and acne is reported as the most common dermatologic diagnosis seen in this population. 1,2 In one study of women aged 10 to 70 years with acne seen at a hospital- based dermatology practice in New York City, clinical acne was more common in Hispanics (32%) than Caucasians (24%). 3 A study of 3,000 Latino patients seen in a private practice setting and hospital-based clinic showed acne to be one of the three most common diagnoses in this patient population. 1 In Hispanics, the most disturbing feature of acne is not the active lesion, but the resulting postinflammatory hyperpigmentation (PIH) and keloidal scarring arising at sites of moderate-to- severe acne, which is very important to keep in mind when treating these patients. Many Hispanic patients are prone to dryness and irritation as a result of treatment, and this can lead to further inflammation and PIH. 4 It is best prevented by early intervention using combination therapy. 5,6 Despite their growing importance in the United States, there are few clinical studies that evaluate the safety and efficacy of topical acne preparations in Hispanics. It is important to balance the need for aggressive early intervention, especially in more severe disease, and it is important to consider the use of treatments that might increase tolerability and limit skin irritation. 7 Approximately 1 to 5 percent of the population is sensitive to benzoyl peroxide (BP), but many can tolerate BP concentrations below 5%. 8 Some physicians have concerns with the use of retinoids due to their potential to include an irritant contact dermatitis, Disclosure: Dr. Alexis is an Advisory Board member for Galderma, Allergan, Novan L'Oreal, and Foamix and an Investigator for Allergan, Galderma, Novan, and BiopharmX. Dr. Cook-Bolden was a principle investigator in the Phase 3 clinical study and an advisor to Valeant Pharmaceuticals North America, LLC. Dr. Lin is an employee of Valeant Pharmaceuticals. Author correspondence: Brian Bulley, MSc; E-mail:

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