Erratum: Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator

This was a randomized, controlled, parallel-group clinical trial with a blinded evaluator, designed to compare the efficacy and safety of the nail lacquer P-3051 with amorolfine 5% in the treatment of mild-to-moderate toenail onychomycosis. Patients were treated for 48 weeks with P-3051 daily, or twice weekly with amorolfine 5%. Out of 120 evaluable patients, 60 (50.0%) received P-3051 and 60 (50.0%) amorolfine 5%. At baseline, the two groups were homogeneous in terms of race, pathogens, number of affected toenails and severity of the infected target nail area. The statistical superiority of P-3051 versus amorolfine was achieved after 48 weeks (treatment success: 58.3% for P-3051 vs. 26.7% for amorolfine, p < 0.001; complete cure: 35.0% for P-3051 vs. 11.7% for amorolfine, p < 0.001). Mycological cure at week 48 was achieved in all patients treated with P-3051 compared to 81.7% of patients treated with amorolfine (p < 0.001). Moreover, fungal eradication by P-3051 was statistically superior at week 24. The results of this study, and of a previous pivotal study versus the insoluble formulation of ciclopirox 8%, led to consider P-3051 as the gold standard for the topical treatment of mild-to-moderate onychomycosis.

本研究为一项设盲评估者的随机对照平行组临床试验，旨在比较甲涂剂P-3051与5%阿莫罗芬（amorolfine）治疗轻中度趾甲甲真菌病（onychomycosis）的疗效与安全性。受试者每日使用P-3051，或每周两次使用5%阿莫罗芬，总治疗周期为48周。在120例可评估受试者中，60例（50.0%）接受P-3051治疗，60例（50.0%）接受5%阿莫罗芬治疗。基线时，两组在种族、致病菌、受累趾甲数量以及感染靶甲区域的严重程度方面均具有同质性。治疗48周后，P-3051的疗效显著优于阿莫罗芬（治疗成功率：P-3051组58.3% vs 阿莫罗芬组26.7%，p<0.001；完全治愈率：P-3051组35.0% vs 阿莫罗芬组11.7%，p<0.001）。治疗48周时，P-3051组受试者的真菌学治愈（mycological cure）率为100%，而阿莫罗芬组为81.7%（p<0.001）。此外，在治疗第24周时，P-3051的真菌清除率同样显著优于阿莫罗芬。本研究与此前一项对比8%环吡酮（ciclopirox）不溶性制剂的关键性研究结果一致，均支持将P-3051作为轻中度甲真菌病外用治疗的金标准。