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首页> 外文期刊>Journal of the European Academy of Dermatology and Venereology: JEADV >Efficacy and safety of a new single-dose terbinafine 1% formulation in patients with tinea pedis (athlete's foot): a randomized, double-blind, placebo-controlled study.
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Efficacy and safety of a new single-dose terbinafine 1% formulation in patients with tinea pedis (athlete's foot): a randomized, double-blind, placebo-controlled study.

机译：一种新型单剂量特比萘芬1％制剂对足癣（脚癣）的疗效和安全性：一项随机，双盲，安慰剂对照研究。

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Background Tinea pedis is a common dermatophyte infection with frequent recurrences. Terbinafine (presently used as a 1-week topical treatment of tinea pedis) is now available in a novel topical solution (film-forming solution - FFS), developed to allow single application. Objectives To demonstrate the efficacy and safety of terbinafine 1% FFS in a randomized, double-blind, placebo-controlled, phase III trial, and to determine relapse or re-infection rate of tinea pedis at 12 weeks. Patients/methods Fifty-four centres (27 in France; 27 in Germany) enrolled 273 evaluable patients (2 : 1 randomization). Patients applied terbinafine 1% FFS or placebo only once between, under and over the toes, soles and sides of both feet. Efficacy assessments included direct microscopy, mycological culture, and clinical signs and symptoms at baseline, and at weeks 1, 6 and 12 after the single drug application. Results Effective treatment (negative mycology plus absent/minimal symptoms) at week 6 in the terbinafine 1% FFSgroup was 63%; vehicle was 17% (P 0.0001). Mycological cure was 72% in the terbinafine group and 21% in the placebo (P 0.0001) at week 6. Clinical signs/symptoms decreased significantly in the active group compared to the placebo. The self-assessment of itching and burning sensation by the patient showed a clear reduction in symptoms starting 15 min after treatment application (this could be attributed to the cooling effect of the FFS). Recurrence (positive culture at 3 months) occurred in 12.5% of the effectively treated patients at week 6 in the terbinafine group. FFS was well tolerated. Conclusion Terbinafine 1% FFS, single dose application is an effective, safe and convenient treatment for tinea pedis. The relapse/re-infection rate 3 months after the end of single-dose therapy is similar to that previously demonstrated in a study using terbinafine 1% cream for 7 days.
机译：背景足癣是常见的皮肤真菌感染，复发频繁。特比萘芬（目前用作足癣的1周局部治疗剂）现已以新型局部溶液（成膜溶液-FFS）的形式开发，可单次使用。目的在一项随机，双盲，安慰剂对照的III期临床试验中证明特比萘芬1％FFS的疗效和安全性，并确定足癣在12周时的复发或再感染率。患者/方法54个中心（法国27个;德国27个）招募了273位可评估患者（2：1随机分组）。患者仅在脚趾，脚底和两侧之间，下方和上方使用一次特比萘芬1％FFS或安慰剂。疗效评估包括直接显微镜检查，真菌培养以及基线时以及单药应用后第1、6和12周的临床体征和症状。结果特比萘芬1％FFS组在第6周的有效治疗（阴性真菌学和无症状/轻微症状）为63％。车辆为17％（P 0.0001）。在第6周时，特比萘芬组的真菌学治愈率为72％，安慰剂组为21％（P 0.0001），与安慰剂相比，活性组的临床体征/症状明显减少。患者对瘙痒和烧灼感的自我评估显示，治疗后15分钟开始症状明显减轻（这可能归因于FFS的清凉作用）。在特比萘芬组中，在第6周有效治疗的患者中有12.5％发生了复发（3个月为阳性培养）。 FFS的耐受性良好。结论特比萘芬1％FFS，单剂应用是一种有效，安全，方便的足癣治疗方法。单剂量治疗结束后3个月的复发/再感染率与先前在使用1％特比萘芬的乳膏治疗7天的研究中所证实的相似。

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