Onychomycosis of ToenailNCT05139888
Light Therapy for Onychomycosis Study
A study testing Single wavelength light (red) only and Dual wavelength light (red/blue) in people with Onychomycosis of Toenail, run by ToeFX Inc. at 1 site in Canada.
Trial summary
This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Single wavelength light (red) only and Dual wavelength light (red/blue)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2020to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light.
Read the 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:
- Determine the safety and efficacy of this therapy in the treatment of distal subungual onychomycosis of the toenail.
- Determine the number of treatments required to clear the nail and to cure the fungus.
- Finalize the treatment protocol, device design and user interface.
- Test re-infection or recurrence of fungus post-treatment.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Single wavelength light (red) only, Dual wavelength light (red/blue)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single wavelength light (red) onlyDevice
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.
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..
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dual wavelength light (red/blue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start19 Feb 2020
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to two different groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- ToeFX Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Rabinovich, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139888
- Sponsor's protocol ID
- TFX-LTS-001
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2021
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05139888
- Acronym / sponsor ID
- TFX-LTS-001
- Conditions
- Onychomycosis of Toenail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- ToeFX Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the safety and efficacy of this therapy in the treatment of distal subungual onychomycosis of the toenail.
- Determine the number of treatments required to clear the nail and to cure the fungus.
- Finalize the treatment protocol, device design and user interface.
- Test re-infection or recurrence of fungus post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to two different groups
| Arm | Type | Receives |
|---|---|---|
| Single wavelength light (red) only | Experimental | Device: Single wavelength light (red) onlyArm 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. |
| Dual wavelength light (red/blue) | Experimental | Device: Dual wavelength light (red/blue)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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single wavelength light (red) onlyClinicians 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 | Single wavelength light (red) only |
| 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.. | Device | Dual wavelength light (red/blue) |
Primary outcome
An Increase in Healthy New Nail Growth Free of Fungal Infection ("Clear Nail") at 12 Months Post-treatment
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Rabinovich, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single wavelength light (red) only and Dual wavelength light (red/blue) in people with Onychomycosis of Toenail, run by ToeFX Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An Increase in Healthy New Nail Growth Free of Fungal Infection ("Clear Nail") at 12 Months Post-treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.