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西班牙裔人群中重度寻常痤疮的治疗:1.2%克林霉素/3.75%过氧化苯甲酰凝胶的疗效和耐受性分析

Treatment of Moderate-to-severe Acne Vulgaris in a Hispanic Population: A Analysis of the Efficacy and Tolerability of Clindamycin 1.2%/Benzoyl Peroxide 3.75% Gel.

作者信息

Alexis Andrew F, Cook-Bolden Fran, Lin Tina

机构信息

Department of Dermatology, Mount Sinai St. Luke's and Mount Sinai West, New York, New York.

Skin Specialty Dermatology and Department of Dermatology, Mount Sinai Health Systems, New York, New York.

出版信息

J Clin Aesthet Dermatol. 2017 Jun;10(6):36-43. Epub 2017 Jun 1.

PMID:28979655
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5605206/
Abstract

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. A 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. Mean reductions in inflammatory and noninflammatory lesions (63.6% and 54.3%, respectively) were significantly greater with clindamycin phosphate 1.2%/BP 3.75% gel versus vehicle (=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. 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.

摘要

寻常痤疮在西班牙裔人群中与其他种族/族裔群体一样极为常见。虽然在不同种族、族裔群体及皮肤类型中,痤疮的表现、对生活质量的影响以及治疗方法存在细微差别,但关于西班牙裔人群的数据有限,而他们却是美国增长最快的人口群体。在西班牙裔人群中治疗痤疮时,刺激、干燥以及色素改变(由痤疮和/或治疗引起)的可能性是关键问题。因此,评估局部治疗在这一不断增长的人群中的疗效和耐受性很重要。一项对136名接受1.2%磷酸克林霉素/3.75%过氧化苯甲酰(BP)凝胶或赋形剂治疗的西班牙裔受试者进行的疗效和皮肤耐受性分析,该研究来自一项针对498名中度至重度痤疮受试者的为期12周的多中心双盲研究。将数据与3期研究中在非西班牙裔人群中观察到的数据进行比较。与赋形剂相比,1.2%磷酸克林霉素/3.75%BP凝胶使炎性和非炎性皮损平均减少率(分别为63.6%和54.3%)显著更高(分别为P=0.001和0.008),且在数值上高于在非西班牙裔人群中观察到的减少率。治疗成功率,即从基线严重程度降低2级(36.5%),在第12周时也高于赋形剂组。皮肤耐受性良好,在第12周时所有平均评分均小于或等于0.2(其中1表示轻度)。没有受试者因不良事件而停药。1.2%磷酸克林霉素/3.75%BP凝胶在西班牙裔人群中耐受性良好且有效。与普通人群相比,未发现西班牙裔痤疮受试者在用1.2%磷酸克林霉素/3.75%BP凝胶治疗时更容易出现皮肤刺激。

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An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris.一种含有1.2%磷酸克林霉素和3.75%过氧化苯甲酰的水性凝胶固定组合,用于每日一次治疗中度至重度寻常痤疮。
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