Clinical research

What is toenail fungus?
Toenail fungus or onychomycosis, also known as tinea unguium, is a chronic fungal infection of the nail bed that impacts millions of people worldwide. Onychomycosis can be caused by a variety of fungal infections caused by dermatophytes, yeasts and non-dermatophytic moulds. The most common cause of onychomycosis worldwide is the dermatophyte T. rubrum. Current global estimates suggest that approximately 11.2% of post-industrial countries suffer from onychomycosis [1]. For the majority of sufferers, treatment can be very challenging with many common treatments having demonstrated low efficacy tied with long durations to cure [2].

To combat the traditionally low efficacy and long treatment durations, ToeFX has introduced a new therapy, ClearToe Therapy, to meet market needs. Studies have shown that the ClearToe protocol, which takes about 30 minutes, clears most infections within 6 months. The ClearToe technology has a proven safety record with no known side effects and has entered the Canadian market with partnerships with domestic foot clinics.

Clinical Trial (1 year study)
Investigational Testing Authorization for this study conducted in Hamilton, Canada was granted by Health Canada in October 2019. The inclusion criteria extended to patients between 18-75 suffering from from distal subungual onychomycosis (DSO), and who agreed to refrain from the use of antifungals or other treatments for the duration of the study. This type of onychomycosis is the most common clinical presentation, in which the distal nail plate is separated from the nail bed. All patients had both clinical presentation and mycological confirmation of fungus. Mycological testing via KOH/microscopy was carried out at the Dynacare laboratory in Brampton, Canada. Patients received the ToeFX treatment every 2 weeks for 8 treatments, with follow-up treatments every 5 weeks thereafter until 6 months. Results were assessed via digital image analysis and via KOH/microscopy.

BEFORE: Toenail infected with fungus, as indicated by discolouration and thickening of the nail.
AFTER: Same toenail after the ToeFX protocol. Photograph does not use lightening effects or filters.

Results: 95% of great toes analyzed responded to the treatment, improvement in clearance of the nail. 76% showed excellent-to-outstanding (50%-100% clearance of the nail) in 4 months. In an anonymous 4-month patient satisfaction survey, 81% of patients rated the appearance of their nails as”much better than before”.

Pilot Study Patients clinically diagnosed with distal subungual onychomycosis (DSO) on at least one toenail by a registered chiropodist or podiatrist were administered the ClearToe treatment. All 11 patients responded to the treatment. 4 severe cases required up to 10 treatments to achieve nail clearance while mild/moderate required only up to 4. Patients arrived at the clinic every 3 weeks and each infected toe was exposed to light.

In vitro and Ex vivo studies (2 years)
The aim of the in vitro study was to identify the optimal conditions for light exposure against T. rubrum, which is the most common fungal species found to contribute to toenail fungus. Ex vivo experimental results were also carried out to test the efficacy and safety of the treatment on human nail pieces. The results showed that the ClearToe Therapy protocol showed strong fungicidal effect against a T. rubrum infection.

Above: A human toenail infected with fungus, magnified 40x under a microscope. The fungal species is Trichophyton rubrum (T. rubrum). The dark “crawling ants” are small colonies of fungi. Image courtesy of the ToeFX Inc. research team.

[1] Toenail onychomycosis: an important global disease burden.  J. Thomas, G.A., Jacobson, C.K. Narkowicz et al.  Journal of Clinical Pharmacy and Therapeutics, 2010.
[2] Fungal Nail Infections (Onychomycosis): A Never-Ending Story?  Mahmoud Ghannoum, Nancy Isham et al., PLOS Pathogens, 2014.