Clinical Drug Investigation ( IF 2.9 ) Pub Date : 2023-07-18 , DOI: 10.1007/s40261-023-01288-1 Shubhadeep D Sinha 1 , Avula Rajamma 2 , Mohan Reddy Bandi 1 , Sreenivasa Chary Sriramadasu 1 , Suvash Sahu 3 , Raj Kumar Kothiwala 4 , Saswati Halder 5 , Abhilash Sankerneni 1 , Muralidhar Panapakam 1 , Venkata Narayana Reddy Vemireddy 1 , Ramya Vattipalli 1 , Srinivas Reddy Devireddy 1
|
Background and Objective
Naftifine, an allylamine, is highly effective against tinea pedis and exhibits relatively greater affinity to skin and nail beds, possibly due to its high lipophilicity. To study the efficacy and safety of naftifine 2% gel in an Indian population, a phase III multicentre double-blind, comparative, parallel-group study was conducted in comparison with miconazole 2% gel in patients with interdigital tinea pedis, with mild to moderate symptoms.
Patients and Methods
Patients presenting with mild to moderate signs and symptoms of interdigital tinea pedis and mycologically confirmed tinea infection were randomised to either naftifine hydrochloride 2% gel (n = 112) or miconazole 2% gel (n = 112) in 1:1 ratio. All patients were treated for 2 weeks with a follow-up of up to 12 weeks. Study evaluations were done at the end of 2, 6, and 12 weeks. The primary efficacy endpoint was the proportion of patients achieving clinical cure at week 6 (± 4 days) and secondary endpoints were the mycological cure at week 6 and week 12 and complete cure at week 12.
Results
At the end of week 6, clinical cure was 54.55% and 50.00% in the naftifine and miconazole groups (p = 0.4960), respectively, and it was increased to 78.18% and 76.36% in the naftifine and miconazole group (p = 0.7455) at the end of week 12. Mycological and clinical cure were similar in the naftifine and miconazole groups at week 6 and week 12. The safety and tolerability profiles of both treatments were similar.
Conclusions
Naftifine 2% gel was efficacious and safe for the treatment of mild to moderate interdigital tinea pedis. Its clinical effectiveness was comparable to that of miconazole 2% gel.
Trial Registration
Clinical Trials Registry of India: CTRI/2021/01/030753.
中文翻译：
盐酸萘替芬 2% 凝胶治疗指间足癣的疗效和安全性：一项针对印度成年患者的随机、双盲、平行组、主动对照 III 期研究
背景和目的
萘替芬是一种烯丙胺，对足癣非常有效，并且对皮肤和甲床具有相对较大的亲和力，这可能是由于其高亲脂性。为了研究萘替芬 2% 凝胶在印度人群中的疗效和安全性，开展了一项 III 期多中心双盲、比较、平行组研究，与轻度至中度指间足癣患者中的咪康唑 2% 凝胶进行比较症状。
患者和方法
出现轻度至中度指间足癣体征和症状以及经真菌学证实的足癣感染的患者被随机分配至 2% 盐酸萘替芬凝胶 ( n = 112) 或 2% 咪康唑凝胶 ( n = 112)，比例为 1:1。所有患者均接受了 2 周的治疗，并进行了长达 12 周的随访。研究评估在第 2、6 和 12 周结束时进行。主要疗效终点是第 6 周（± 4 天）时实现临床治愈的患者比例，次要终点是第 6 周和第 12 周的真菌学治愈以及第 12 周的完全治愈。
结果
第6周结束时，萘替芬组和咪康唑组临床治愈率分别为54.55%和50.00%（p = 0.4960），萘替芬组和咪康唑组临床治愈率分别提高至78.18%和76.36%（p = 0.7455）第 12 周结束时。在第 6 周和第 12 周，萘替芬组和咪康唑组的真菌学和临床治愈率相似。两种治疗的安全性和耐受性特征相似。
结论
2%萘替芬凝胶治疗轻中度指间足癣有效且安全。其临床疗效与2%咪康唑凝胶相当。
试用注册
印度临床试验注册中心：CTRI/2021/01/030753。
京公网安备 11010802027423号