一项双盲、随机、赋形剂对照研究，评估2%萘替芬乳膏治疗股癣的疗效和安全性。

A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris.

作者信息

Parish Lawrence Charles, Parish Jennifer L, Routh Hirak B, Avakian Edward, Olayinka Babajide, Pappert Eric J, Plaum Stefan, Fleischer Alan B, Hardas Bhushan

机构信息

Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA.

出版信息

J Drugs Dermatol. 2011 Oct;10(10):1142-7.

PMID:21968664

Abstract

OBJECTIVE

Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch").

METHODS

A total of 334 subjects with T. cruris were enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes from baseline in clinical status and laboratory studies.

RESULTS

At week 4, 25 percent of naftifine-treated subjects achieved complete cure vs. three percent of vehicle subjects and 72 percent achieved mycological cure vs. 16 percent of vehicle treated subjects (one-sided, P<0.001). Treatment effectiveness was achieved in 60 percent of NAFT-2% subjects vs. 10 percent of vehicle subjects (one-sided, P<0.001). Clinical cure rate and clinical success rate were 33 percent and 84 percent in NAFT-2% subjects, respectively vs. 10 percent and 46 percent in vehicle subjects (both P is less than 0.001, 2-sided). Week 2 efficacy response rates in NAFT-2% subjects were all lower than at week 4 but were significantly higher than week 2 vehicle-treated counterparts (P<0.025). Treatment-related AE occurred in 11 subjects (7 NAFT-2%, 4 vehicle) during the study. The most common AE in both groups were contact dermatitis (2 NAFT-2%), pruritus (2 vehicle), and application site reaction (1 per group).

CONCLUSION

NAFT-2% applied once daily for two weeks (one-half the treatment duration for naftifine 1% cream) is efficacious and safe for the treatment of T. cruris.

摘要

目的

2%盐酸萘替芬乳膏（NAFT - 2%）是一种正在美国研发的外用烯丙胺类抗真菌制剂。本随机、双盲、赋形剂对照研究的目的是评估为期两周、每日一次的NAFT - 2%与赋形剂治疗股癣（“股癣”）的疗效和安全性。

方法

共纳入334例股癣患者，随机分为NAFT - 2%组（n = 166）或赋形剂组（n = 168），每日涂抹一次，共14天。在第2周（治疗结束时）和第4周评估疗效和安全性。疗效指标包括完全治愈、治疗有效、真菌学治愈、临床治愈和临床成功，仅在基线时氢氧化钾（KOH）和皮肤癣菌培养阳性的受试者中进行分析（NAFT - 2%组n = 75；赋形剂组n = 71）。通过不良事件以及临床状态和实验室检查相对于基线的变化评估安全性。

结果

在第4周时，萘替芬治疗组25%的受试者实现完全治愈，而赋形剂组为3%；72%的受试者实现真菌学治愈，而赋形剂治疗组为16%（单侧，P < 0.001）。NAFT - 2%组60%的受试者治疗有效，而赋形剂组为10%（单侧，P < 0.001）。NAFT - 2%组的临床治愈率和临床成功率分别为33%和84%，而赋形剂组分别为10%和46%（均P < 0.001，双侧）。NAFT - 2%组第2周的疗效反应率均低于第4周，但显著高于第2周赋形剂治疗组（P < 0.025）。在研究期间，11名受试者（7名NAFT - 2%组，4名赋形剂组）出现与治疗相关的不良事件。两组中最常见的不良事件为接触性皮炎（2名NAFT - 2%组）、瘙痒（2名赋形剂组）和用药部位反应（每组各1名）。