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Onychomycosis of ToenailPhase 1/2NCT05674747

Pilot Study of Swift Microwave Device for Onychomycosis

A Phase 1/2 study testing Swift Microwave treatment - weekly x 4wks, Swift Microwave treatment - Every other week x 4wks and Swift Microwave treatment - Every other week x 24wks in people with Onychomycosis of Toenail, run by Mediprobe Research Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Onychomycosis of Toenail
What is being tested?
Swift Microwave treatment - weekly x 4wks, Swift Microwave treatment - Every other week x 4wks and Swift Microwave treatment - Every other week x 24wks
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteCanada
Study dates
27 Mar 2023to 8 Nov 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • No more than 4 toenails showing visual signs of onychomycosis, including the target toenail.
  • Subject agrees not to have any oral antifungal treatment or topical onychomycosis treatment during the study.
  • Able to perform study assessments.

Who cannot join

  • Proximal subungual onychomycosis (PSO).
  • Superficial white onychomycosis (SWO).
  • 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.
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  • Patients diagnosed with Diabetes Mellitus (types I and II).
  • Peripheral vascular disease.
  • Recurrent cellulitis.
  • Lymphatic insufficiency.
  • Immunocompromised (due to underlying medical disorders or to immunosuppressive treatments).
  • Exhibit an increased risk of bacterial infections due to skin breakdown induced by a fungus
  • Have a current infection or condition of the feet (fungal or otherwise) which may require antifungal or antibacterial treatment during therapy that may confound the study data.
  • Nails for treatment involving the lunula.
  • Co-morbidities including psoriasis, lichen planus or other medical conditions known to induce nail changes.
  • Patients with trauma from ill-fitting shoes, running or overly-aggressive nail care.
  • Subjects that have podiatric/ nursing nail care on a regular basis.
  • Previous target toenail surgery with any residual disfigurement.
  • Nails infected with Candida.
  • Any uncontrolled condition which, in the opinion of the Investigator, may put the subjects at undue risk of adverse effects during the study.
  • Subjects who have had any topical onychomycosis medication for at least 3-months prior to start of treatment or oral antifungal medication at least 6-months prior to study treatment.
  • Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable device.
  • Metal implants at the site of treatment (within foot or ankle).
  • Severe moccasin tinea pedis.
  • Known allergy or intolerance to microwave therapy.
  • Subject who has had any topical metallic or ionic treatment (e.g, aluminum chloride, silver nitrate) in the target or treated toenail areas within the last 6 months and agrees not to use any during the study.
  • Current participation in a non-observational trial, or have done so within the last 30-days.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Mediprobe Research Inc

    London, Ontario, N5X 2P1

Other trials in Canada

About this study

Official title: Pilot Study to Determine the Safety and Efficacy of Regimen Frequencies Using the Swift Microwave Device for Mild to Moderate Toenail Onychomycosis Caused by Dermatophytes

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.

Read the detailed description

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.

Being tested
Swift Microwave treatment - weekly x 4wks, Swift Microwave treatment - Every other week x 4wks, Swift Microwave treatment - Every other week x 24wks
Keywords
tinea unguium, dermatophyte
Medical subject headings
Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Swift Microwave treatment - weekly x 4wksDevice

    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 4wksDevice

    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 24wksDevice

    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).

Study groups in NCT05674747
Study groupRoleWhat they receive
Group A-Weekly x 4wkExperimentalSubjects 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.
Receives: Device: Swift Microwave treatment - weekly x 4wks
Group B-Biweekly x4wkExperimentalSubjects 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.
Receives: Device: Swift Microwave treatment - Every other week x 4wks
Group C-Biweekly x 24wksExperimentalSubjects 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.
Receives: Device: Swift Microwave treatment - Every other week x 24wks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Month 6

  2. 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

    Measured: Month 6

Secondary outcomes (4)

  1. 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).

    Measured: Month 12

  2. 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

    Measured: Month 6

  3. Proportion of patients per group with Mycological Cure

    Microscopy negative and culture negative

    Measured: Month 6, Month 9, Month 12

  4. Proportion of patients per group with Effective Cure

    <=10% affected area in target toenail with mycological cure

    Measured: Month 6, Month 9, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start27 Mar 2023
  3. Primary completion8 Nov 2024
  4. Study completion8 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05674747
Sponsor's protocol ID
FN1p
Status last verified
Nov 2024
First submitted
15 Dec 2022
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39624747

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Swift Microwave treatment - weekly x 4wks, Swift Microwave treatment - Every other week x 4wks and Swift Microwave treatment - Every other week x 24wks in people with Onychomycosis of Toenail, run by Mediprobe Research Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients able to complete treatment regimen per protocol (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05674747, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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