Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies
Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies
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DOI：
10.1016/j.jaad.2012.10.013
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发表时间：
2013-04-01
影响因子：
13.8
通讯作者：
Olin, Jason T.
中科院分区：
文献类型：
--
作者：
Elewski, Boni E.;Rich, Phoebe;Olin, Jason T.
背景：甲真菌病是一种常见的指甲感染，常导致甲板损伤和畸形。局部涂漆治疗效果微乎其微。目的：研究甲真菌病患者应用10%依非康唑溶液的安全性和有效性。方法：对甲真菌病患者(20%~50%临床受累程度，研究1：870，研究2：785)进行两项相同的多中心随机双盲对照研究。患者被随机(3：1)服用依非那康唑或赋形剂，每天一次，持续48周，治疗后4周进行随访。没有进行清创手术。主要终点为52周的完全治愈率(0%临床受累，氢氧化钾检查和真菌培养均为阴性)。结果：依非康唑的真菌学治愈率(研究1：55.2%，研究2：53.4%)明显高于安慰剂(P<；001)。研究1：17.8%vs3.3%，研究2：15.2%vs5.5%，依非那康唑的主要终点，完全治愈也显著更高(P<；001)。治疗成功率(受影响的目标脚趾甲百分比[0%-
Background: Onychomycosis is a common nail infection, often resulting in nail plate damage and deformity. Topical lacquer treatments have negligible efficacy. Oral treatments, although more efficacious, are limited by drug interactions and potential hepatotoxicity.Objective: We investigated the safety and efficacy of efinaconazole 10% solution (efinaconazole), the first triazole antifungal developed for distal lateral subungual onychomycosis.Methods: Two identical, multicenter, randomized, double-blind, vehicle-controlled studies were conducted in patients with toenail distal lateral subungual onychomycosis (20%-50% clinical involvement [study 1: N = 870, study 2: N = 785]). Patients were randomized (3: 1) to efinaconazole or vehicle, once daily for 48 weeks, with 4-week posttreatment follow-up. Debridement was not performed. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52.Results: Mycologic cure rates were significantly greater with efinaconazole (study 1: 55.2%, study 2: 53.4%) compared with vehicle (P< . 001). The primary end point, complete cure, was also significantly greater for efinaconazole (study 1: 17.8% vs 3.3%, study 2: 15.2% vs 5.5%, P < . 001). Treatment success (percent affected target toenail [0%-