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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the ToeFX Therapy Light treatment for toenail fungus?

A review of light-based technologies for treating foot infections suggests that phototherapy, including ultraviolet and infrared light therapies, is being explored for its potential to treat fungal infections like toenail fungus. These technologies are currently being tested in clinical trials, indicating a growing interest in their effectiveness. ^{1 2 3 4 5}

Is light therapy for toenail fungus safe for humans?

The research articles provided do not contain specific safety data for light therapy for toenail fungus or ToeFX Therapy Light. They focus on photosensitivity reactions related to certain antibiotics, which is not directly applicable to light therapy for toenail fungus. ^{6 7 8 9 10}

How does the ToeFX Therapy Light treatment for toenail fungus differ from other treatments?

ToeFX Therapy Light is unique because it uses light therapy, which is a non-invasive method that doesn't rely on traditional antifungal drugs. This approach is similar to photodynamic therapy (PDT), which combines light with a photosensitive compound to target the fungus, offering an alternative to oral medications that can have side effects. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the ToeFX Therapy Light, a special light treatment for toenail fungus, in 100 patients. The light is believed to kill the fungus causing the infection, offering a potential new solution for those who haven't had success with other treatments.

Research Team

Alexander Rabinovich, MD

Principal Investigator

McMaster University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in Onychomycosis: A Review of Psychometrically Evaluated Instruments in Assessing Treatment Effectiveness. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A review of current research in light-based technologies for treatment of podiatric infectious disease states. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

How often does oral treatment of toenail onychomycosis produce a disease-free nail? An analysis of published data. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Oral treatments for toenail onychomycosis: a systematic review. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Oral antifungal therapies for toenail onychomycosis: a systematic review with network meta-analysis toenail mycosis: network meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Photosensitivity reactions caused by lomefloxacin hydrochloride: a multicenter survey. [2020]

7. Slovenia pubmed.ncbi.nlm.nih.gov

Sparfloxacin-induced photo-onycholysis and photosensitivity characteristically sparing lepromatous skin lesions: an interesting observation. [2019]

8. Australia pubmed.ncbi.nlm.nih.gov

Photo-onycholysis due to sparfloxacin. [2013]

9. Japan pubmed.ncbi.nlm.nih.gov

[The dose-response study of sparfloxacin against skin and soft tissue structure infections in the field of surgery]. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Phototoxicity and photoallergenicity of quinolones in guinea pigs. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Efficiency of methylene blue-mediated photodynamic therapy vs intense pulsed light in the treatment of onychomycosis in the toenails. [2019]

12. England pubmed.ncbi.nlm.nih.gov

A new model of in vitro fungal biofilms formed on human nail fragments allows reliable testing of laser and light therapies against onychomycosis. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing photodynamic therapy based on methylene blue dye and fluconazole for toenail onychomycosis. [2014]

14. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Study of Non-thermal Laser Therapy for the Treatment of Toenail Onychomycosis. [2023]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Fast elimination of onychomycosis by hematoporphyrin derivative-photodynamic therapy. [2013]