Pilot Study of Swift Microwave Device for Onychomycosis

NCT05674747 | Completed Phase 1

• 1 other identifier: FN1p
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Onychomycosis of Toenail

Keywords

tinea unguium; dermatophyte

Outcome Measures

Primary Outcomes (2)

• 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: 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

  Month 6

Secondary Outcomes (4)

• Number of patients able to complete Long-term treatment

  Month 12

• Proportion of patients achieving End of Month 6 Efficacy

  Month 6

• Proportion of patients per group with Mycological Cure

  Month 6, Month 9, Month 12

• Proportion of patients per group with Effective Cure

  Month 6, Month 9, Month 12

Study Arms (3)

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.

Device: Swift Microwave treatment - weekly x 4wks

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.

Device: Swift Microwave treatment - Every other week x 4wks

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.

Device: Swift Microwave treatment - Every other week x 24wks

Interventions

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).

Group A-Weekly x 4wk

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).

Group B-Biweekly x4wk

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).

Group C-Biweekly x 24wks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mediprobe Research Inc.: lead
• Emblation Limited: collaborator

Study Sites (1)

Mediprobe Research Inc

London, Ontario, N5X 2P1, Canada

Location

Related Publications (1)

• 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.

  PMID: 39624747 DERIVED

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aditya Gupta, MD,PhD

  Mediprobe Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 6, 2023
• Study Start: March 27, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)