Light Therapy for Toenail Fungus

Overseen By Irit Van-Ham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ToeFX Inc.

Must not be taking: Antifungals, Investigational drugs

Disqualifiers: Pregnancy, Immunodeficiency, Psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new light therapy for toenail fungus, focusing on the safety and effectiveness of the ToeFX Therapy Light. Participants will receive either red light or a combination of red and blue light to determine which improves nail health more effectively. The trial seeks individuals with mild to moderate toenail fungus who have a positive test confirming the infection and are willing to stop using nail polish and antifungal products during the study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in toenail fungus treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop using topical steroids, topical antifungals, and systemic antifungals for the duration of the study. If you are currently using these medications, you will need to stop them to participate.

What prior data suggests that the ToeFX Therapy Light is safe for treating toenail fungus?

Research shows that the ToeFX Therapy Light is safe for treating toenail fungus. This light therapy uses photodisinfection, a method that employs light to kill bacteria and fungi. It is a non-toxic, pain-free treatment with no reported side effects or recovery time. It provides temporary relief from toenail fungus.

The ToeFX system has two versions: one uses only red light, and the other combines red and blue light. Both versions are safe. The blue light may offer additional benefits, such as reducing swelling, which could help some patients achieve better results.

Although researchers continue to study this treatment, the FDA has already cleared ToeFX Light Therapy for use, indicating its likely safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the ToeFX Therapy Light for toenail fungus because it uses light therapy, which is a non-invasive treatment option, unlike conventional methods that often rely on oral antifungal medications or topical creams. The trial is exploring two light therapy techniques: one uses a single wavelength of red light, while the other combines red and blue light. The inclusion of blue light is particularly intriguing because it may offer anti-inflammatory benefits, potentially enhancing treatment effectiveness and patient outcomes. This approach could lead to a faster, safer, and more comfortable way to tackle onychomycosis, making it a promising alternative to traditional treatments.

What evidence suggests that the ToeFX Therapy Light is effective for toenail fungus?

Research shows that ToeFX Therapy Light is a promising treatment for toenail fungus. In this trial, participants will join different treatment arms to evaluate its effectiveness. Research has well-documented the single wavelength light (red) for treating toenail fungus, and it will be tested in one arm of this trial. The dual wavelength light (red/blue), tested in another arm, includes a blue light component, which some research suggests may help reduce inflammation, possibly improving treatment results. Clinically, ToeFX has significantly cleared fungus, making it a safe and effective option for those dealing with this condition. ^{1 2 3 4 5}

Who Is on the Research Team?

Alexander Rabinovich, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate toenail fungus on at least one big toe, confirmed by a positive mycology test. Participants must not use nail polish or other medications on the affected nails during the study and should not have used antifungal treatments recently. Pregnant women, nursing mothers, smokers, and those with certain health conditions or allergies are excluded.

Inclusion Criteria

I agree not to use nail polish or medication on my toenails unless my doctor says it's okay.

I agree not to use any nail or skin steroids, antifungals, or systemic antifungals during the study.

My toenail fungus test for common dermatophytes like T. rubrum was positive.

Exclusion Criteria

I haven't had cancer (except for nonmelanoma skin cancer) or an immune deficiency in the last 4 years.

I don't have conditions affecting drug absorption, uncontrolled diabetes, significant vascular issues, or major illnesses in the last 30 days.

You are allergic to skin creams, ointments, medications, or certain chemicals used in skincare products.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ToeFX Therapy Light treatment for distal subungual onychomycosis

6-12 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ToeFX Therapy Light

Trial Overview The ToeFX Therapy Light's safety and effectiveness in treating toenail fungus are being tested. The study compares two types of light therapy: one using only red light and another combining red and blue light wavelengths.

How Is the Trial Designed?

Group I: Single wavelength light (red) only Experimental Treatment 1 Intervention

Arm 1 will test the core technology of the ToeFX system; this study reproduces methods well-described in the literature. After application of the formulation, nails affected by onychomycosis are exposed to red light at a wavelength of 630-660 nm intensity of 200 mW/cm2.

Group II: Dual wavelength light (red/blue) Experimental Treatment 1 Intervention

Some research has shown that exposure to mild blue light can have anti-inflammatory effects that would improve patient onychomycosis outcomes. We will assess whether inclusion of blue light in the protocol affects the clinical outcome.

Who Is Running the Clinical Trial?

ToeFX Inc.

Lead Sponsor

Trials

1

Recruited

100+

Citations

1. toefx.com toefx.com/provider/science/

The Science Behind ToeFX – ToeFX Clinician Site The ToeFX Therapy Light is a safe, non-toxic and effective treatment option for temporary clearance of toenail fungus (onychomycosis). Talk to us about ...

2. withpower.com withpower.com/trial/phase-onychomycosis-1-2020-102c3

Light Therapy for Toenail Fungus · Info for Participants This trial aims to test the safety and effectiveness of the ToeFX Therapy Light, a special light treatment for toenail fungus, in 100 patients.

3. onlyfootcare.com onlyfootcare.com/toefx/

ToeFX ClearToe Light Therapy by ToeFX is a new, safe and effective in-clinic treatment for onychomycosis (fungal nails) using photodisinfection therapy.

4. ctv.veeva.com ctv.veeva.com/study/light-therapy-for-onychomycosis-study

Light Therapy for Onychomycosis Study - ClinicalTrials.Veeva This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light.

5. ocfla.net ocfla.net/services/toefx-therapy/

ToeFX Light Therapy for Toenail Fungus Clinically Proven Results: Treatment every two weeks has been clinically proven to result in significant clearance of toenail fungus; Fast and Effective: You ...