A Phase 1/2 interventional study of Swift Microwave treatment - weekly x 4wks and Swift Microwave treatment - Every other week x 4wks in Onychomycosis of Toenail, sponsored by Mediprobe Research Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Mediprobe Research Inc. · Phase 1/2, Interventional, and Treatment
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.
This is an open, single site, pilot study in Canadian subjects diagnosed with mild to moderate toenail onychomycosis caused by dermatophytes. A total of 45 subjects will be enrolled in the study. All eligible subjects who provide written informed consent will be randomized to one of three groups (15 subjects in each group): Group A, B or C.
The treatment regimen for each group is as follows:
Group A: Subjects will receive treatment on Day 0 and then weekly in the first month followed by monthly treatment for a further 4 months (9 treatments).
Group B: Subjects will receive treatment on Day 0 and then every two weeks in the first month followed by monthly treatment for a further 4months (7 treatments).
Group C: Subjects will receive treatment on Day 0 and then once every two weeks in the first six months (12 treatments).
For all groups, patients not achieving 'FDA efficacy' levels at Month 6 End Visit and/or Month 9 End Visit will be offered continuation of treatments once monthly for 3 months to determine if additional treatment will continue to be safe and increase efficacy. Patients may refuse additional treatment, while continuing in safety follow-up to Months 9/12.
Subjects will be followed up every 3 months for safety and efficacy to Month 12, and at any treatment intervals occurring between these main visits. Efficacy will be assessed by changes in affected nail area and length, both in clinic and through photos. Mycology sampling will be performed at pre-determined intervals to assess fungal presence and viability post-treatment.
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's enrollment of 39 is below the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →This is the only study on the registry with Mediprobe Research Inc. as lead sponsor.
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Exclusion Criteria:
Subjects will receive treatment on Day 0 and then weekly in the first month followed by monthly treatment to Month 6 (9 treatments). Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
Device: Swift Microwave treatment - weekly x 4wks
Subjects will receive treatment on Day 0 and then every two weeks in the first month followed by monthly treatment to Month 6 (7 treatments). Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
Device: Swift Microwave treatment - Every other week x 4wks
Subjects will receive treatment on Day 0 and then once every two weeks in the first six months (12 treatments). Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
Device: Swift Microwave treatment - Every other week x 24wks
Swift device set up to 7-9 Watts applied locally for up to a 3 second burst to the toenail. Start at 9 Watts and apply locally for up to a 3 second burst; adjust the dose and duration as is tolerable for the subject. Repeat on the infected parts of the nail as is tolerable for the subjects ( up to 5 repetitions).
Swift device set up to 7-9 Watts applied locally for up to a 3 second burst to the toenail. Start at 9 Watts and apply locally for up to a 3 second burst; adjust the dose and duration as is tolerable for the subject. Repeat on the infected parts of the nail as is tolerable for the subjects ( up to 5 repetitions).
Swift device set up to 7-9 Watts applied locally for up to a 3 second burst to the toenail. Start at 9 Watts and apply locally for up to a 3 second burst; adjust the dose and duration as is tolerable for the subject. Repeat on the infected parts of the nail as is tolerable for the subjects ( up to 5 repetitions).
Number of patients able to complete treatment regimen per protocol
Proportion of Patients able to complete therapy as planned, and summary list of treatment-related Adverse Events reported cross-referenced to severity (mild/moderate/severe) and resolution frequency (resolved before further treatment with no sequelae).
Time frame: Month 6
Proportion of Patients per group with 'Temporary Increase in Clear Nail'
'FDA Efficacy' - regimen meets the FDA definition of 'temporary increase in clear nail' in the Target Toenail: 1. Evidence of nail improvements noted at End of Month 3 using either clear nail increase measured from proximal nail fold, or by increase in clear nail area, AND efficacy at End of Month 6 defined by at least one of the following: 2. At least 6mm increase in clear nail measured from the proximal nail fold 3. An additional 60mm2 of clear nail with evidence of outward growth 4. Complete clearance if less than 6mm distal nail was involved prior to treatment
Time frame: Month 6
Number of patients able to complete Long-term treatment
Proportion of Patients able to complete therapy beyond Month 6, if required, and summary list of treatment-related Adverse Events reported cross-referenced to severity (mild/moderate/severe) and resolution frequency (resolved before further treatment with no sequelae).
Time frame: Month 12
Proportion of patients achieving End of Month 6 Efficacy
At least one of the following in the Target Toenail: 1. At least 3mm increase in clear nail measured from the proximal nail fold 2. A 30% increase in area of clear nail, with evidence of outward growth
Time frame: Month 6
Proportion of patients per group with Mycological Cure
Microscopy negative and culture negative
Time frame: Month 6, Month 9, Month 12
Proportion of patients per group with Effective Cure
\<=10% affected area in target toenail with mycological cure
Time frame: Month 6, Month 9, Month 12
Plan to share: No
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