← Back to Search

Microwave Device

Microwave Treatment for Toenail Fungus

Phase 1 & 2

Waitlist Available

Led By Aditya Gupta, MD,PhD

Research Sponsored by Mediprobe Research Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Severe moccasin tinea pedis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6, month 9, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial compares microwave treatments for toenail fungus in Canadian patients. Safety, improvement & fungus inactivation/elimination will be measured over 12 months. Extra treatments may be given if improvement isn't seen.

Who is the study for?

This trial is for Canadian adults with mild to moderate toenail fungus, specifically dermatophytes affecting the great toenail. Participants should have a target toenail thickness of 3mm or less and not be pregnant or breastfeeding. They must agree not to use other fungal treatments during the study and cannot have diabetes, certain nail conditions, metal implants in the foot/ankle area, allergies to microwave therapy, or be immunocompromised.

What is being tested?

The study tests three different schedules of Swift Microwave treatment on toenail fungus: weekly for four weeks; every other week for four weeks; and every other week for twenty-four weeks. The effectiveness will be judged by adverse events related to treatment, clinical improvement of the treated nail, and elimination of the fungus at various intervals up to one year after starting treatment.

What are the potential side effects?

Potential side effects from Swift Microwave treatments may include discomfort at the site of application, skin irritation around the treated nail, temporary increase in local temperature sensation during treatment sessions. Specific side effects will be monitored as part of this pilot study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a fungal nail infection in my big toenail.

Select...

My big toenail is 20-75% affected by the condition.

Select...

My toenail fungus is confirmed to be caused by a specific fungus.

Select...

I have 4 or fewer toenails with signs of fungal infection.

Select...

I agree not to take oral antifungal or treat nail fungus topically during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't used metallic or ionic treatments on my toenail in the last 6 months and agree not to use any during the study.

Select...

I have severe athlete's foot in a moccasin pattern.

Select...

I have a fungal nail infection that affects the surface of my nail.

Select...

I have a fungal nail infection with thick masses under the nail.

Select...

My toenail fungus extends less than 3mm from the base of my nail.

Select...

My nail infection is caused by rare fungi or non-fungal organisms.

Select...

I have a fungal nail infection near the cuticle.

Select...

I have been diagnosed with diabetes.

Select...

I have had cellulitis more than once.

Select...

I have a condition where my lymphatic system is not working properly.

Select...

My nails are infected with a fungus called Candida.

Select...

I have had toenail surgery that left my toe looking different.

Select...

I have a condition affecting the blood vessels outside my heart and brain.

Select...

My nails show lines, spots, streaks, yellowing, green debris, or notches but no fungal infection.

Select...

I do not have a foot infection that needs treatment during the study.

Select...

My immune system is weak due to a condition or treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 9, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 9, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 9, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients able to complete treatment regimen per protocol

Proportion of Patients per group with 'Temporary Increase in Clear Nail'

Secondary study objectives

Number of patients able to complete Long-term treatment

Proportion of patients achieving End of Month 6 Efficacy

Proportion of patients per group with Effective Cure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group C-Biweekly x 24wksExperimental Treatment1 Intervention

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.

Group II: Group B-Biweekly x4wkExperimental Treatment1 Intervention

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 III: Group A-Weekly x 4wkExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Swift Microwave treatment - Every other week x 24wks

2023

Completed Phase 2

~40

Swift Microwave treatment - weekly x 4wks

2023

Completed Phase 2

~40