Onychomycosis of Toenail
Conditions
Brief 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.
Interventions
DEVICESingle 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.
DEVICEDual 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..
Sponsors
ToeFX Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to two different groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| An Increase in Healthy New Nail Growth Free of Fungal Infection ("Clear Nail") at 12 Months Post-treatment | 12 months | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAlexander Rabinovich, MD
McMaster University
Participant flow
Recruitment details
A total of 126 participants were enrolled across four clinical centers in Canada between 2020 and 2023 (Hamilton, ON; Langley, BC; and Windsor, ON). Participants were adults (ages 33-98, mean 61 ± 11 years) with clinically confirmed distal-lateral subungual or totally dystrophic onychomycosis. Exclusion criteria included diabetes; patients with other comorbidities were included. 101 received red light therapy, and 25 received dual-wavelength therapy, with no overlap between groups.
Pre-assignment details
All patients provided written informed consent. Participants discontinued systemic, topical, and home antifungal treatments for at least 30 days before enrollment. Nails were debrided before treatment to reduce hyperkeratosis and optimize light penetration.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.0 Years STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Canada | 25 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 25 |
| other Total, other adverse events | 0 / 101 | 0 / 25 |
| serious Total, serious adverse events | 0 / 101 | 0 / 25 |
Outcome results
None listed