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
Abstract 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 clin...
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Wiley
2024-12-01
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| Series: | Skin Health and Disease |
| Online Access: | https://doi.org/10.1002/ski2.455 |
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| author | Aditya K. Gupta Elizabeth A. Cooper Tong Wang |
| author_facet | Aditya K. Gupta Elizabeth A. Cooper Tong Wang |
| author_sort | Aditya K. Gupta |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-c3bf0cb8115142df9cd3697fffd14a5e |
| institution | Kabale University |
| issn | 2690-442X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
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| series | Skin Health and Disease |
| spelling | doaj-art-c3bf0cb8115142df9cd3697fffd14a5e2024-12-02T04:03:51ZengWileySkin Health and Disease2690-442X2024-12-0146n/an/a10.1002/ski2.455Safety and efficacy of the swift microwave device in patients with mild‐to‐moderate onychomycosis: Protocol of an open‐label, randomized, dose‐finding pilot studyAditya K. Gupta0Elizabeth A. Cooper1Tong Wang2Division of Dermatology Department of Medicine, Temerty Faculty of Medicine University of Toronto Toronto Ontario CanadaMediprobe Research Inc. London Ontario CanadaMediprobe Research Inc. London Ontario CanadaAbstract 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.https://doi.org/10.1002/ski2.455 |
| spellingShingle | Aditya K. Gupta Elizabeth A. Cooper Tong Wang 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 Skin Health and Disease |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://doi.org/10.1002/ski2.455 |
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