Trial Outcomes & Findings for Light Therapy for Onychomycosis Study (NCT NCT05139888)
NCT ID: NCT05139888
Last Updated: 2026-05-05
Results Overview
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.
COMPLETED
NA
126 participants
12 months
2026-05-05
Participant Flow
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.
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.
Unit of analysis: Nails
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
101 165
|
25 50
|
|
Overall Study
COMPLETED
|
101 165
|
25 50
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Wavelength Light (Red) Only
n=165 Nails
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.
|
Dual Wavelength Light (Red/Blue)
n=50 Nails
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.
|
Total
n=215 Nails
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 Years
STANDARD_DEVIATION 11.0 • n=101 Participants
|
54.4 Years
STANDARD_DEVIATION 11.1 • n=25 Participants
|
59.7 Years
STANDARD_DEVIATION 11.1 • n=126 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=101 Participants
|
7 Participants
n=25 Participants
|
40 Participants
n=126 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=101 Participants
|
18 Participants
n=25 Participants
|
86 Participants
n=126 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
101 participants
n=101 Participants
|
25 participants
n=25 Participants
|
126 participants
n=126 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Single Wavelength Light (Red) Only
n=165 Nails
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.
|
Dual Wavelength Light (Red/Blue)
n=50 Nails
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.
|
|---|---|---|
|
An Increase in Healthy New Nail Growth Free of Fungal Infection ("Clear Nail") at 12 Months Post-treatment
|
5.9 millimeters (mm)
Standard Deviation 4.5
|
5.5 millimeters (mm)
Standard Deviation 4.5
|
Adverse Events
Single Wavelength Light (Red) Only
Dual Wavelength Light (Red/Blue)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place