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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

Summary

Onychomycosis, commonly known as toenail fungus, is a widespread infection affecting millions of people. Current treatments often fail or cause side effects. This study tests a new microwave device that heats the infected nail to kill the fungus without harming surrounding tissue or causing systemic side effects. Researchers are testing three different treatment schedules to find the most effective approach.

Background

Onychomycosis is a common fungal nail disease with prevalence up to 14% in North America and 24% in Europe. Current treatment options have limitations including high recurrence risk, safety concerns with oral agents, and low rates of achieving both clinical and mycological cure. Device-based microwave treatments offer potential advantages by directly targeting infection sites while minimizing systemic side effects.

Objective

To evaluate the safety and efficacy of the Swift microwave device administered at three different dosing regimens in 45 patients with mild-to-moderate distal subungual onychomycosis. Secondary objective is to identify an optimal dosing regimen to inform future pivotal trials.

Results

Enrollment began March 2023 with 39 patients enrolled as of May 2024 due to difficulty confirming positive dermatophyte infection. Study visits continue through 2024, with interim data expected December 2024 and anticipated trial completion by May 2025. Results not yet available as this is a protocol publication.

Conclusion

This pilot study will be the first to evaluate microwave treatment safety and efficacy for onychomycosis in a trial setting using US FDA recommended endpoints and mycological testing. Results will help determine optimal dosing regimens and inform design of future pivotal trials for this device-based treatment approach.
  • Published in:Skin Health and Disease,
  • Study Type:Clinical Trial - Protocol,
  • Source: PMID: 39624747, DOI: 10.1002/ski2.455
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