Pilot Study of Swift Microwave Device for Onychomycosis (NCT05674747) | Clinical Trial Compass
CompletedPhase 1/2
Pilot Study of Swift Microwave Device for Onychomycosis
Canada39 participantsStarted 2023-03-27
Plain-language summary
This is an open, single site, pilot study in Canadian subjects diagnosed with mild to moderate toenail onychomycosis caused by dermatophytes. Three microwave treatment frequencies will be compared for efficacy and safety, evaluated by frequency of treatment-related adverse events, clinical improvement of a treated target toenail and inactivation/elimination of fungus in the target toenail. Outcomes will be evaluated at Month 6, Month 9 and Month 12 after initiation of treatments. Subjects not achieving 'temporary increase in clear nail' at Month 6 may receive extra microwave treatments to Month 9 or Month 12 to improve outcomes.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent.
✓. Aged 18 years and above.
✓. Not Pregnant or breast feeding.
✓. Distal subungual onychomycosis (DSO) in a great toenail.
✓. One great toenail as a target for treatment having at least 20% involvement of the nail area and no more than 75% involvement of the nail area.
✓. Target toenail thickness 3mm or less.
✓. No area of infection \< 3mm from the proximal nail fold.
✓. Toenail for treatment with fungal infection confirmed by detection of a dermatophyte organism (i.e. Trichophyton rubrum).
Exclusion criteria
✕. Proximal subungual onychomycosis (PSO).
✕. Superficial white onychomycosis (SWO).
✕
What they're measuring
1
Number of patients able to complete treatment regimen per protocol
Timeframe: Month 6
2
Proportion of Patients per group with 'Temporary Increase in Clear Nail'
. Nail changes that appear as parallel lines, small pinpoint depressions, brown spots, black or brown linear streaks, complete yellowing of all nails without textural change, green debris below the nail or notches in the nail margin ('non-onychomycotic dystrophy').
✕. Nails infected by rare fungal species or non-fungal organisms such as mould or bacteria
✕. "Spike" of onychomycosis extending to \<3mm from the eponychium (proximal nail fold) of the target toenail.
✕. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
✕. Patients diagnosed with Diabetes Mellitus (types I and II).