MedPharm Ltd., Unit 3/Chancellor Court, 50 Occam Road, Surrey Research Park, Guildford, GU2 7AB, UK.
Am J Clin Dermatol. 2013 Oct;14(5):413-9. doi: 10.1007/s40257-013-0031-y.
Tinea pedis is one of the world's most prevalent dermatophyte infections. MedSpray™ tinea pedis 1 % w/w (topical spray) is a novel, easy-to-use propellant-based spray formulation containing 1 % w/w terbinafine, requiring no manipulation at the site of infection. This is in contrast to the only formulation currently approved in Europe for single application (none are approved in the USA for single use), which is Lamisil(®) Once 1 % w/w (topical solution), containing 1 % w/w terbinafine hydrochloride, which requires manipulation on the affected area.
The aim of this study was to evaluate the efficacy, tolerability and consumer acceptability of a topical spray versus a topical solution in the treatment of tinea pedis.
This study is a phase IIa, randomised, observer-blind, non-inferiority comparative study of the topical spray compared with the topical solution over a 12-week study period. The study was conducted at Bioskin GmbH, Hamburg and Berlin. Patients (n = 120) who presented with the presence of interdigital tinea pedis caused by dermatophytes on one or both feet were enrolled in the study. Patients were randomly assigned between the two treatment groups. Either the topical spray or the topical solution was administered by the study nurse and consisted of a single application (equivalent to 20 mg of terbinafine per foot) on day 1 of the study. No further applications were made for the duration of the study. The hypothesis formulated before commencement of the study was that the topical spray would prove to be non-inferior to the topical solution. Efficacy assessments, including clinical signs and symptoms, mycology and microscopy were performed at baseline and 1, 6 and 12 weeks after treatment.
The rate of mycological cure at week 1 was statistically equivalent for both treatments. There was a significant reduction in the overall clinical score as assessed by the Physician's Global Assessment of signs and symptoms for both treatment groups.
The topical spray and the topical solution showed comparable anti-fungal activity. Furthermore, the non-inferiority of topical spray to the topical solution was confirmed as determined by the proportion of patients categorised as successfully treated at week 1. This confirms that a topical spray product, which can be applied once without touching the affected skin, is equally as effective in the treatment of tinea pedis and removes the risk of organism transfer associated with touching infected areas.
EudraCT-No. 2008-002399-92.
足癣是世界上最普遍的皮肤癣菌感染之一。MedSpray™ 足癣 1%w/w（喷雾）是一种新型、易于使用的推进剂喷雾配方，含有 1%w/w 的特比萘芬，在感染部位无需任何操作。这与目前在欧洲唯一批准用于单次应用的配方（在美国均未批准单次使用）形成对比，后者是 Lamisil(®)Once 1%w/w（溶液），含有 1%w/w 的盐酸特比萘芬，需要在受影响的区域进行操作。
本研究旨在评估一种喷雾与一种溶液在治疗足癣方面的疗效、耐受性和消费者接受度。
这是一项 IIa 期、随机、观察者盲、非劣效性比较研究，比较了喷雾与溶液在 12 周研究期间的疗效。该研究在 Bioskin GmbH（汉堡和柏林）进行。患有由一种或两种足部皮肤癣菌引起的指间型足癣的患者（n=120）参与了这项研究。患者被随机分配到两组治疗组。研究护士为患者使用喷雾或溶液治疗，第一天给予单次应用（每只脚相当于 20mg 特比萘芬）。在研究期间不再进行其他应用。在研究开始前制定的假设是，喷雾将被证明不劣于溶液。在治疗前、治疗后 1、6 和 12 周进行疗效评估，包括临床体征和症状、真菌学和显微镜检查。
第 1 周时，两种治疗方法的真菌学治愈率在统计学上是等效的。两组患者的整体临床评分（医生对体征和症状的全球评估）均显著降低。
喷雾和溶液都显示出相似的抗真菌活性。此外，第 1 周成功治疗的患者比例证实了喷雾与溶液相比具有非劣效性。这证实了一种无需接触受影响皮肤即可单次应用的喷雾产品，在治疗足癣方面同样有效，并消除了接触感染区域相关的微生物转移风险。
EudraCT-No. 2008-002399-92。
