Rao M Kanaka Prasad, Siddananjappa Lokesh, Sidana Neetu, Deshmukh Ashish, Diwari Binayak, Podder Indrasish, Kumar Surendra, Mittal Ravindra, Daultani Pavankumar, Jaiswal Ashok, Chinda Monika
General Medicine, Rajiv Gandhi Institute of Medical Sciences, Srikakulam, IND.
Dermatology, Glow Skin Centre, Nagpur, IND.
Cureus. 2024 May 12;16(5):e60162. doi: 10.7759/cureus.60162. eCollection 2024 May.
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.
To evaluate the efficacy and safety of amorolfine lotion 0.25% compared to amorolfine cream 0.25% in patients with dermatophytosis.
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.
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.
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.
皮肤癣菌病是浅表真菌感染的主要原因，需要局部和全身使用抗真菌药物。阿莫罗芬是一种吗啉衍生物，是一种新的局部抗真菌药物，有乳膏和洗剂两种剂型。
评估0.25%阿莫罗芬洗剂与0.25%阿莫罗芬乳膏治疗皮肤癣菌病患者的疗效和安全性。
进行了一项多中心随机、双臂、活性对照、平行、非劣效性III期临床试验，纳入284例皮肤癣菌病患者，试验组使用阿莫罗芬洗剂，参照组使用阿莫罗芬乳膏。研究药物于每晚使用一次，持续四周，患者随后再随访两周。主要终点为临床治愈，次要终点包括真菌学治愈、综合治愈、整体疗效评估和治疗后复发情况。评估安全性和耐受性。
在纳入的患者中，股癣患者分别占69.9%和68.1%，而股癣患者分别占30.1%和31.9%。两组中的大多数患者（试验组99.3%，参照组97%）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%。试验组综合治愈率为98.6%，参照组为96.3%。试验组有2例（1.4%）患者报告了2起不良事件，参照组有3例（2.1%）患者报告了3起不良事件，所有不良事件均为轻度，无需支持性药物治疗，在三天内即可缓解。所有研究对象均未报告严重不良反应。
0.25%（w/v）阿莫罗芬洗剂在皮肤癣菌病患者中显示出非劣效的临床、真菌学和综合治愈率，耐受性良好，安全性与0.25%（w/w）阿莫罗芬乳膏相似。
