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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

This study evaluates a new microwave device (Swift System) as a potential treatment for fungal nail infections (onychomycosis). The device uses microwave energy to heat and eliminate fungal infections directly at the nail site, avoiding the side effects of oral medications. Researchers tested three different treatment schedules in 39 patients over 12 months to find the most effective dosing 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 treatment offers potential for directly targeting infection sites while minimizing systemic side effects.

Objective

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

Results

Enrollment was completed in May 2024 with 39 patients enrolled due to difficulty confirming positive dermatophyte infection. Study visits continue through 2024 with interim data available in December 2024 and anticipated trial completion by May 2025. Results pending.

Conclusion

This protocol represents the first trial evaluating safety and efficacy of microwave treatment for onychomycosis using both FDA-recommended endpoints and mycological testing. The dose-finding design will help identify optimal treatment parameters for future pivotal studies. Trial status is active with recruitment complete as of May 2024.
  • Published in:Skin Health and Disease,
  • Study Type:Clinical Trial - Protocol,
  • Source: PMC11608870, PMID: 39624747, DOI: 10.1002/ski2.455
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