Efficacy and safety of luliconazole 5% nail solution for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study
Efficacy and safety of luliconazole 5% nail solution for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study
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DOI：
10.1111/1346-8138.13816
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发表时间：
2017-07-01
影响因子：
3.1
通讯作者：
Okubo, Akihiro
中科院分区：
文献类型：
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作者：
Watanabe, Shinichi;Kishida, Hiroshi;Okubo, Akihiro
甲真菌病是一种非常普遍和难治性的疾病。一线治疗药物是口服制剂，但有效的局部药物治疗一直是人们所期望的。目的是探讨5%咪唑类抗真菌药物luliconazole甲液治疗甲真菌病的疗效和安全性。一项多中心、双盲、随机III期研究在影响大趾甲的日本远侧甲下甲真菌病患者中进行，临床累及率为20-50%。患者被随机分配（2:1）至吕立康唑组或安慰剂组，每天1次，持续48周。主要终点是完全治愈率（临床治愈率[0%临床累及指甲]加上真菌学治愈率[直接镜检阴性结果]）。监测不良事件发生率以评价安全性。完全治愈率显著优于对照组（5.1%,5/99）（P = 0.012）。露立康唑直接镜检阴性率（45.4%,79/174）显著高于对照组（31.2%,29/93）（P = 0.026）。未见严重药物不良反应。我们的结论是，每日一次局部使用5%的露立康唑甲液显示出临床疗效，并证实耐受性良好。
Onychomycosis is a highly prevalent and intractable disease. The first-line treatment agents are oral preparations, but an effective topical medication has long been desired. The objective was to investigate the efficacy and safety of luliconazole 5% nail solution, an imidazole antifungal agent, for the treatment of patients with onychomycosis. A multicenter, double-blind, randomized phase III study was conducted in Japanese patients with distal lateral subungual onychomycosis affecting the great toenails, with 20-50% clinical involvement. Patients were randomized (2:1) to luliconazole or vehicle once daily for 48 weeks. The primary end-point was the complete cure rate (clinical cure [0% clinical involvement of the nail] plus mycological cure [negative results on direct microscopy]). The adverse event incidence was monitored to evaluate safety. The complete cure rate significantly favored luliconazole (14.9%, 29/194 subjects) versus vehicle (5.1%, 5/99) (P = 0.012). Similarly, the negative direct microscopy rate was significantly higher with luliconazole (45.4%, 79/174) than with vehicle (31.2%, 29/93) (P = 0.026). There were no serious adverse drug reactions. We conclude that once daily topical luliconazole 5% nail solution demonstrated clinical efficacy and was confirmed to be well tolerated.