Light Therapy for Onychomycosis Study

NCT05139888 | Completed Results

• 1 other identifier: TFX-LTS-001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light.

Conditions

Onychomycosis of Toenail

Outcome Measures

Primary Outcomes (1)

• An Increase in Healthy New Nail Growth Free of Fungal Infection ("Clear Nail") at 12 Months Post-treatment

  The investigators will assess whether participants achieve at least a 6 mm increase in clear nail, an additional 60 mm² of clear nail, or complete clearance at 12 months after the first treatment. Clear nail growth will be measured in millimeters (mm) from the base of the toenail using standardized digital photographs obtained at baseline and follow-up. The length of unaffected nail will be measured along the midpoint from the nail fold to the proximal border of the affected region (lowest point affected). Change in clear nail length between baseline and 12 months will be calculated. An increase indicates improvement and is considered positive for study success, while a decrease indicates worsening and is considered negative.

  12 months

Study Arms (2)

Single wavelength light (red) only

EXPERIMENTAL

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 42 mW/cm2.

Device: Single wavelength light (red) only

Dual wavelength light (red/blue)

EXPERIMENTAL

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.

Device: Dual wavelength light (red/blue)

Interventions

Single wavelength light (red) only DEVICE

Clinicians should confirm a diagnosis of distal subungual onychomycosis (DSO). Clinician should assign an OSI score to each nail using the Onychomycosis Severity Index (OSI). The ToeFX system is intended for use in any room in which standard foot care treatments are routinely administered. Debridement should not be carried out more proximally than the most proximal margin of the dystrophic nail, as this can interfere with assessment of clear nail area attributable to the device intervention. The clinician should debride the nail, apply formula, and position the affected foot directly under the ToeFX ClearToe Therapy red light (640-660 nm). For safety, the light has a built-in timer and automatically switches off after 15 minutes. The process should be repeated every 2 weeks for 6 months.

Single wavelength light (red) only

Dual wavelength light (red/blue) DEVICE

Clinicians should confirm a diagnosis of distal subungual onychomycosis (DSO). Clinician should assign an OSI score to each nail using the Onychomycosis Severity Index (OSI). The ToeFX system is intended for use in any room in which standard foot care treatments are routinely administered. Debridement should not be carried out more proximally than the most proximal margin of the dystrophic nail, as this can interfere with assessment of clear nail area attributable to the device intervention. The clinician should debride the nail, apply formula, and position the affected foot directly under the ToeFX ClearToe Therapy dual wavelength light (640-660 nm and 405-450 nm). For safety, the light has a built-in timer and automatically switches off after 15 minutes. The process should be repeated every 2 weeks for 6 months..

Dual wavelength light (red/blue)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement, without lunular or proximal involvement.
• exhibit positive mycology results (i.e., KOH test and culture of a dermatophyte) from the target great toenail, confirming common dermatophytes such as T. rubrum.
• are willing to refrain from using polish or other medication on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator.
• are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails or systemic antifungals for the duration of the study.
• are willing to provide signed and dated written voluntary informed consent in English before any protocol-specific procedures are performed.
• are able to complete the study and comply with study instructions.

You may not qualify if:

• females who are pregnant, plan to become pregnant during the study, or are nursing a child.
• persons who are hypersensitive to topical creams, ointments, medications, or surfactants.
• persons who have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study.
• persons who have received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
• persons who have participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product.
• persons who are not prepared to give up use of any nail cosmetic products for the duration of the study.
• persons currently suffering from any disease or condition, that could include abnormal laboratory tests, and/or who are currently using medication which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
• patients with glucose-6 phosphate dehydrogenase (G6PD) deficiency or hypersensitivity/allergies to methylene blue
• persons with a history of any condition that could possibly affect absorption of drug (e.g., gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular disease or peripheral circulatory impairment, or has had any major illness within 30 days prior to the screening examination.
• persons with a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
• smokers.

Sponsors & Collaborators

• ToeFX Inc.: lead

Study Sites (1)

ArthoBiologix

Hamilton, Ontario, L9H7T6, Canada

Location

Limitations and Caveats

Diagnostic criteria and treatment protocols varied slightly across study sites. Debridement technique was not standardized, with clinicians using different burrs, drill types, and speeds. In addition, the dual-wavelength cohort was a small exploratory sample from a single site, which may introduce some variability and limits direct comparison across groups.

Results Point of Contact

• Title: Dr. Alexander Rabinovich
• Organization: McMaster University

Office@DrAlex.ca

289-389-8181

Study Officials

• Alexander Rabinovich, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to two different groups

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: February 19, 2020
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)