What is toenail fungus?

Toenail fungus, medically referred to as onychomycosis or tinea unguium, presents as a persistent fungal infection affecting the nail bed, impacting millions of individuals across the globe. This condition can be attributed to various fungal sources, including dermatophytes, yeasts, and non-dermatophytic molds. Among these, the most prevalent cause of onychomycosis worldwide is the dermatophyte known as T. rubrum. Present global assessments indicate that approximately 11.2% of populations in post-industrial nations contend with onychomycosis. Regrettably, treatment for many individuals can prove to be exceptionally challenging, as common therapies have demonstrated limited effectiveness and require prolonged durations to achieve a cure.

In response to the historical challenges associated with low treatment effectiveness and extended therapy durations, ToeFX has introduced an innovative solution known as ClearToe Therapy, designed to address the specific needs of patients. Research studies have demonstrated that the ClearToe protocol, which requires approximately 30 minutes per session, can visibly improve the condition of infected toenails within a span of 6 months. Importantly, ClearToe technology has an established track record of safety, with no documented adverse reactions.

Clinical Trial (1-year study):
The eligibility criteria for participation in this study encompassed individuals aged 18 to 75 who were grappling with distal subungual onychomycosis (DSO) and agreed to abstain from using antifungal agents or alternative treatments throughout the study period. DSO represents the most common clinical manifestation, characterized by the separation of the distal nail plate from the nail bed. All patients underwent both clinical assessment and mycological confirmation of fungal presence. Mycological examinations, involving KOH/microscopy, were conducted at Dynacare and LifeLabs Laboratories in Ontario, Canada. Patients received the ToeFX treatment every 2 weeks for a total of 8 sessions, followed by subsequent treatments at 5-week intervals for a period of 6 months. Evaluation of results was performed through digital image analysis and KOH/microscopy.

Findings: Among the toes examined, a remarkable 76% exhibited outstanding to excellent improvement, characterized by a reduction in the affected nail’s fungal coverage area ranging from 50% to 100%, all achieved within a span of 6 months. Impressively, the treatment elicited a positive response in 97% of the toes subjected to the study.

In Vitro and Ex Vivo Investigations (Conducted in collaboration with the Xu laboratory at the Department of Biology, McMaster University):
The primary objective of the in vitro and ex vivo investigations was to pinpoint the optimal conditions for exposing T. rubrum, the predominant fungal species associated with toenail fungus, to light. Furthermore, ex vivo experiments were conducted to assess the effectiveness and safety of the treatment on human nail samples. The results unequivocally demonstrated that the ClearToe Therapy protocol exerted a potent fungicidal effect against T. rubrum infections.

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.


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