According to a report published by the NCBI on January 14, 2015, some 3 to 12% of the population is affected by toenfail fungus, with older populations more likely to be affected. Indeed, fungal infection of nails (onychomycosis) is among the most prevalent infectious diseases in humans. According to a communication released by the Ontario College of Physicians and Surgeons in September 2019, the cure rate for topical treatments is only 6-23% after 1 year. Even after 1 year of treatment, topical treatments have limited efficacy. Moreover, onychomycosis is cosmetically distressing.~This study will be an open-label, prospective pilot study. The subjects will be 100 patients who suffer from distal subungual onychomycosis. The purpose of the study is to establish the efficacy of the ToeFX Therapy Light, which has shown compelling results in in vitro and ex vivo (cadaver) studies but has not been tested in patients. Specifically, the investigators wish to:~Determine the safety and efficacy of this therapy in the treatment of distal subungual onychomycosis of the toenail.~Determine the number of treatments required to clear the nail and to cure the fungus.~Finalize the treatment protocol, device design and user interface.~Test re-infection or recurrence of fungus post-treatment.
This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light.