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 patient needs. Studies have shown that the ClearToe protocol, which takes about 30 minutes, can clear the apperance of infected toenails within 6 months. The ClearToe technology has a proven safety record with no recorded adverse reactions.

Clinical Trial (1 year study)

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 and LifeLabs Laboratories in Ontario, 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.

Results:  76% of toes analyzed showed excellent-to-outstanding (50% to 100% reduction in the surface area of the nail covered by fungus) within 6 months.  97% of toes studied responded to the treatment.

In vitro and Ex vivo studies (in partnership with the Xu laboratory at Department of Biology, McMaster University)
The aim of the in vitro and ex vivo studies 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.

Results in 8-10 Treatments

76% of patients see substantial or total clearance.