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COMPLETED

NCT05139888

Light Therapy for Onychomycosis Study

Sponsor: ToeFX Inc.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2020-02-19

Completion Date

2023-12-19

Last Updated

2026-05-05

Healthy Volunteers

Yes

Conditions

Onychomycosis of Toenail

Interventions

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..

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

ArthoBiologix

Hamilton, Ontario, Canada