Light Therapy for Onychomycosis Study | NCT05139888

NCT05139888

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Alexander Rabinovich, MD	McMaster University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
ArthoBiologix		Hamilton	Ontario	L9H7T6	Canada

Arm/Group Information

ID	Title	Description
FG000	Single Wavelength Light (Red) Only	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.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Single Wavelength Light (Red) Only	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.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	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.	The analysis population includes all nails with measurable baseline and follow-up photographs. Differences between participant counts and unit counts reflect that outcomes were analyzed per nail (units), not per participant. The red-light cohort included 165 analyzable nails from 101 participants, and the dual-wavelength cohort included 50 analyzable nails from 25 participants.	Posted		Mean	Standard Deviation	millimeters (mm)		12 months	Nails	Nails

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Single Wavelength Light (Red) Only	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. 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.

Title	Organization	Phone	Extension	Email
Dr. Alexander Rabinovich	McMaster University	289-389-8181		Office@DrAlex.ca

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 22, 2022	Nov 13, 2025	Prot_SAP_000.pdf

ID	Title	Description
OG000	Single Wavelength Light (Red) Only	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.
OG001	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.