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西班牙裔人群中中度至重度寻常痤疮的治疗:1.2%克林霉素/2.5%过氧化苯甲酰凝胶疗效和耐受性的事后分析

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.

作者信息

Cook-Bolden Fran E

机构信息

Skin Specialty Dermatology, New York, NY 10155, USA.

出版信息

J Drugs Dermatol. 2012 Apr;11(4):455-9.

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.

摘要

背景

西班牙裔人群中的痤疮问题日益严重,带来了独特的挑战。尽管联合疗法目前是痤疮治疗的标准方法,但人们担心该人群中潜在的刺激性增加、皮肤干燥以及色素沉着的可能性。评估痤疮药物在西班牙裔人群中的疗效和耐受性的临床研究较少。

方法

对458名接受1.2%磷酸克林霉素/2.5%过氧化苯甲酰凝胶、单一活性成分及赋形剂治疗的西班牙裔受试者进行疗效和皮肤耐受性的事后分析,这两项为期12周的多中心双盲研究共纳入2813名中度至重度痤疮患者。

结果

与单一活性成分及赋形剂相比,1.2%磷酸克林霉素/2.5%过氧化苯甲酰凝胶使炎症性皮损、非炎症性皮损及总皮损的中位数减少幅度(分别为71.6%、50.9%和55.1%)显著更大。在第12周时,治疗成功率(35.6%“清除/几乎清除”)和患者满意度(83.2%)也显著高于赋形剂组。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(1表示轻度)。

结论

与整个研究人群相比,1.2%磷酸克林霉素/2.5%过氧化苯甲酰凝胶在西班牙裔人群中的总体疗效和耐受性更好。未发现西班牙裔痤疮患者使用1.2%磷酸克林霉素/2.5%过氧化苯甲酰凝胶治疗时更容易出现皮肤刺激,且疗效和耐受性均良好。

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