NCT05139888

Light Therapy for Onychomycosis Study

A Pilot Study Evaluating the Feasibility and Usability of ToeFX Light Therapy Device for Mild to Moderate Distal Subungual Onychomycosis (DSO) of the Toenail

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: ToeFX Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

According to a report published by the NCBI on January 14, 2015, some 3 to 12% of the population is affected by toenfail fungus, with older populations more likely to be affected. Indeed, fungal infection of nails (onychomycosis) is among the most prevalent infectious diseases in humans. According to a communication released by the Ontario College of Physicians and Surgeons in September 2019, the cure rate for topical treatments is only 6-23% after 1 year. Even after 1 year of treatment, topical treatments have limited efficacy. Moreover, onychomycosis is cosmetically distressing. This study will be an open-label, prospective pilot study. The subjects will be 100 patients who suffer from distal subungual onychomycosis. The purpose of the study is to establish the efficacy of the ToeFX Therapy Light, which has shown compelling results in in vitro and ex vivo (cadaver) studies but has not been tested in patients. Specifically, the investigators wish to: 1. Determine the safety and efficacy of this therapy in the treatment of distal subungual onychomycosis of the toenail. 2. Determine the number of treatments required to clear the nail and to cure the fungus. 3. Finalize the treatment protocol, device design and user interface. 4. Test re-infection or recurrence of fungus post-treatment.

Conditions

• Onychomycosis of Toenail

Interventions

Type	Name	Description
DEVICE	Single wavelength light (red) only	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.
DEVICE	Dual wavelength light (red/blue)	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..

Timeline

• Start date: 2020-02-19
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2021-12-01
• Last updated: 2023-11-28

Locations

1 site across 1 country: Canada