Safety and efficacy of the swift microwave device in patients with mild-to-moderate onychomycosis: Protocol of an open-label, randomized, dose-finding pilot study.

BACKGROUND

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.

METHODS

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.

DISCUSSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT05674747.