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| Name | Class |
|---|---|
| Emblation Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-Weekly x 4wk | Experimental | 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. |
|
| Group B-Biweekly x4wk | Experimental | 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. |
|
| Group C-Biweekly x 24wks | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swift Microwave treatment - weekly x 4wks | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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:
| Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditya Gupta, MD,PhD | Mediprobe Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mediprobe Research Inc | London | Ontario | N5X 2P1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39624747 | Derived | Gupta AK, Cooper EA, Wang T. 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 Dis. 2024 Oct 10;4(6):e455. doi: 10.1002/ski2.455. eCollection 2024 Dec. |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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|
| Swift Microwave treatment - Every other week x 4wks | Device | 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 Microwave treatment - Every other week x 24wks | Device | 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). |
|
| Proportion of patients achieving End of Month 6 Efficacy |
At least one of the following in the Target Toenail:
|
| Month 6 |
| Proportion of patients per group with Mycological Cure | Microscopy negative and culture negative | Month 6, Month 9, Month 12 |
| Proportion of patients per group with Effective Cure | <=10% affected area in target toenail with mycological cure | Month 6, Month 9, Month 12 |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |