Gupta Aditya K, Cooper Elizabeth A, Wang Tong
Division of Dermatology Department of Medicine, Temerty Faculty of Medicine University of Toronto Toronto Ontario Canada.
Mediprobe Research Inc. London Ontario Canada.
Skin Health Dis. 2024 Oct 10;4(6):e455. doi: 10.1002/ski2.455. eCollection 2024 Dec.
Onychomycosis is a common fungal nail disease with a prevalence rate up to 14% in North America and 24% in Europe. The current treatment paradigm is limited by a high risk of disease recurrence, safety concerns for oral agents, and a low likelihood of patients achieving both clinical improvement and mycological cure. Recent advances in device-based treatments have allowed for the direct targeting of the infection site that bypasses drug resistance mechanisms while minimizing systemic side-effects. The Swift System is a microwave device that has demonstrated therapeutic potential in treating skin (e.g. verrucae vulgaris, actinic keratosis) and nail infections.
We report the protocol of an open-label, randomized, pilot study that will be conducted at a single Canadian center. Our primary objective is to evaluate the safety and efficacy of microwave treatment (Swift System, Emblation Ltd, Scotland, U.K.), administered at three different dosing regimens, in 45 patients with mild-to-moderate distal subungual onychomycosis. Our secondary objective is to identify an optimal dosing regimen, if any, to better inform the conduct of a future pivotal trial. Patients will be randomized (1:1:1) to undergo either 9 treatment sessions (5 weekly sessions plus 4 monthly sessions), 7 treatment sessions (3 sessions every 2 weeks plus 4 monthly sessions), or 12 treatment sessions every 2 weeks. At each session microwave energy will be applied in 3-s intervals at 7-9 Watts, repeated up to 5 times at each treatment position on the nail. Overlapping treatment positions are used to ensure sufficient coverage of the infected area. Patients will be enrolled in the trial over a 12-month period. Efficacy will be evaluated based on visual improvement and mycology testing results. Adverse events will be recorded throughout the entire study period.
This study will be the first to report on the safety and efficacy of microwave treatment in onychomycosis patients in a trial setting; recruitment is ongoing.
ClinicalTrials.gov, NCT05674747.
甲癣是一种常见的指甲真菌病，在北美患病率高达14%，在欧洲为24%。当前的治疗模式受到疾病复发风险高、口服药物安全性问题以及患者实现临床改善和真菌学治愈可能性低的限制。基于设备的治疗方法的最新进展使得能够直接针对感染部位，绕过耐药机制，同时将全身副作用降至最低。Swift系统是一种微波设备，已在治疗皮肤（如寻常疣、光化性角化病）和指甲感染方面显示出治疗潜力。
我们报告一项开放标签、随机、试点研究的方案，该研究将在加拿大的一个中心进行。我们的主要目标是评估微波治疗（Swift系统，Emblation Ltd，英国苏格兰）在45例轻至中度远端甲下甲癣患者中采用三种不同给药方案的安全性和有效性。我们的次要目标是确定一种最佳给药方案（如果有的话），以便为未来的关键试验提供更好的指导。患者将被随机分组（1:1:1），接受9次治疗（每周5次，共5周，外加每月4次）、7次治疗（每2周3次，共3周，外加每月4次）或每2周12次治疗。每次治疗时，微波能量将以每秒7 - 9瓦的间隔施加3秒，在指甲的每个治疗部位重复最多5次。使用重叠的治疗部位以确保感染区域得到充分覆盖。患者将在12个月内入组该试验。疗效将根据视觉改善和真菌学检测结果进行评估。在整个研究期间记录不良事件。
本研究将是首个在试验环境中报告微波治疗甲癣患者安全性和有效性的研究；招募工作正在进行中。
ClinicalTrials.gov，NCT05674747。
