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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37 JCAD journal of clinical and aesthetic dermatology June 2017 • Volume 10 • Number 6 P O S t P H O C A N A L Y S I S which could lead to PIH. 9 The safety and efficacy of clindamycin phosphate 1.2%/BP 3.75% gel in moderate-to-severe acne has been established in a multicenter, randomized, double-blind study involving almost 500 patients. 10 Here, the authors provide a post-hoc analysis of the Hispanic subpopulation in this study. METHODS A total of 498 patients with moderate- to-severe facial acne, aged 12 years and older, were randomized (1:1) to receive clindamycin phosphate 1.2%/BP 3.75% gel or vehicle in a multicenter, double- blind, controlled, 12-week study. The study was conducted in accordance with the Declaration of Helsinki and good clinical practices, and in compliance with local regulatory requirements. All subjects provided written informed consent before entering the study. Before randomization, patients were stratified by severity of acne vulgaris (Evaluator Global Severity Score [EGSS], ranging from 0 [clear] to 5 [very severe]). They were dichotomized into a moderate acne group (EGSS of 3) and severe acne group (EGSS of 4). The post-hoc analysis included 136 Hispanic acne subjects (27.3% of the total study population) who were randomized to clindamycin phosphate 1.2%/BP 3.75% gel or vehicle. Study population. Eligible subjects for the post-hoc analysis included male and female Hispanic patients aged 12 to 40 years, with moderate-to-severe acne (a score of 3 or 4 on the EGSS), who presented with 20 to 40 inflammatory lesions (papules, pustules, and nodules), 20 to 100 noninflammatory lesions (open and closed comedones), and two nodules or less. Efficacy evaluation. Efficacy evaluations of the face comprised inflammatory and noninflammatory lesion counts, and an EGSS at screening, baseline, and during treatment (Weeks 4, 8, and 12) performed by the investigator. Primary efficacy endpoints included absolute change from baseline to Week 12 in mean inflammatory and noninflammatory lesion counts, and the proportion of patients who achieved at least a 2-grade reduction from baseline to Week 12 in the EGSS. Secondary efficacy endpoints included mean percent change from baseline to Week 12 in lesion counts and subject self- assessment (SSA) at baseline and Weeks 4, 8, and 12. In these evaluations, subjects assessed their acne relative to baseline using a scale ranging from 1 (clear) to 7 (worse). Safety evaluation. The investigator assessed cutaneous safety and tolerability evaluations at each study visit. Cutaneous safety evaluations included erythema and scaling, and tolerability evaluations included itching, burning, and stinging; each evaluated on a scale from 0 (none) to 3 (severe). The investigator assessed erythema and scaling at the time of the study visit. Itching, burning, and stinging were solicited from the patient. Safety was also evaluated through reported adverse events (AEs), which were summarized by treatment group, severity, and relationship to treatment. Statistical analysis. The intent-to- treat (ITT) population comprised all patients randomized and provided study drug. The safety population comprised all randomized patients who were presumed to have used the study medication at least once and who provided at least one positive baseline evaluation. The investigator assessments (EGSS, [Abstract continued] clindamycin phosphate 1.2%/BP 3.75% gel versus vehicle (P=0.001 and 0.008, respectively) and numerically greater than the reductions seen in the non-Hispanic population. treatment success, a 2-grade reduction in severity from baseline (36.5%), was also 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). No subjects discontinued due to adverse events. Conclusion: Clindamycin phosphate 1.2%/BP 3.75% gel was well tolerated and efficacious in the Hispanic population. Compared with the general population, Hispanic acne subjects were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BP 3.75% gel. J Clin Aesthet Dermatol. 2017;10(6):36–43.

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