背景:皮肤病,浅表真菌感染的主要原因,需要局部和全身抗真菌药物。Amorolfine,吗啉衍生物,是一种新的局部抗真菌剂,可用于乳膏和乳液配方。
目的:评估与0.25%的amorolfine乳膏相比0.25%的amorolfine洗剂在皮肤癣菌病患者中的疗效和安全性。
方法:多中心随机,双臂,主动控制,平行,进行了284例皮肤癣菌病患者的非劣效性III期临床试验,测试臂使用amorolfine乳液,参考臂使用amorolfine乳膏。研究药物每天在晚上施用一次,持续四周,并对患者进行另外两周的随访。主要终点是临床治愈,而次要终点包括真菌学治愈,复合固化,全球疗效评估,治疗后复发。评估安全性和耐受性。
结果:在入选患者中,69.9%和68.1%的患者患有体癣,而股癣占30.1%和31.9%。两组中的大多数患者(99.3%的测试和97%的参考)在治疗结束时实现了临床治愈。真菌学治愈率分别为98.6%和96.3%。在测试臂中实现了98.6%的复合固化,而在参考臂中实现了96.3%的复合固化。试验组2例(1.4%)患者共报告2例不良事件,参照组3例(2.1%)患者报告3例不良事件。所有AE均为轻度,且在不使用支持性药物的情况下在3天内消退.在任何研究受试者中均未报告严重的不良反应。
结论:阿莫罗芬洗剂0.25%w/v显示非劣质临床,真菌学,和皮肤癣菌病患者的复合治疗,耐受性良好,并且具有与Amorolfine乳膏0.25%w/w相似的安全性。
BACKGROUND: Dermatophytosis, a major cause of superficial fungal infections, requires topical and systemic antifungals. Amorolfine, a morpholine derivative, is a new topical antifungal available in cream and lotion formulations.
OBJECTIVE: To evaluate the efficacy and safety of amorolfine lotion 0.25% compared to amorolfine cream 0.25% in patients with dermatophytosis.
METHODS: A multi-center randomized, two-arm, active-controlled, parallel, non-inferiority phase III clinical trial involving 284 dermatophytosis patients was conducted, with the test arm using amorolfine lotion and the reference arm using amorolfine cream. The study drugs were applied once daily in the evening for four weeks and patients were followed up for another two weeks. The primary endpoint was clinical cure, while secondary endpoints included mycological cure, composite cure, global efficacy assessment, and post-treatment relapse. Safety and tolerability were assessed.
RESULTS: Amongst the enrolled patients, 69.9% and 68.1% of patients had tinea corporis, while 30.1% and 31.9% had tinea cruris. The majority of patients in both groups (99.3% test and 97% reference) achieved a clinical cure at the end of treatment. Mycological cure was achieved by 98.6% and 96.3% respectively. A composite cure was achieved by 98.6% in the test arm versus 96.3% in the reference arm. A total of two AEs were reported in two (1.4%) patients in the test group and three AEs were reported in three (2.1%) patients in the reference group, all of the AEs were mild and resolved within three days without supportive medication. No severe adverse effects were reported in any of the study subjects.
CONCLUSIONS: Amorolfine lotion 0.25% w/v showed a non-inferior clinical, mycological, and composite cure in dermatophytosis patients, was well-tolerated, and had a similar safety profile to amorolfine cream 0.25% w/w.