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.
Results: 95% of patients responded to the treatment, with all but one showing improvement in clearance of the nail. 73% of patients 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".
Case studies of 11 volunteers were undertaken in partnership with a foot clinic in Ontario, Canada. The purpose of these studies was to test the treatment protocol in a clinic setting, and to gain patient and clinician feedback on the comfort and efficacy of the device. Patients clinically diagnosed with distal subungual onychomycosis (DSO) on at least one toenail by a registered chiropodist or podiatrist were administered the ClearToe treatment. Serum was painted onto the infected toenail, followed by exposure under the ClearToe Therapy Light for 15 minutes. 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.
BEFORE: Toenail infected with fungus, as indicated by discolouration and thickening of the nail.
AFTER; Same toenail after 9 months using the ToeFX protocol. Photograph does not use lightening effects or filters.
In vitro and Ex vivo studies
ToeFX tested the efficacy of the ClearToe serum in a laboratory setting, via a research project spanning two years conducted in partnership with the Xu lab at McMaster University's Department of Biology. The aim of the in vitro study was to identify the optimal combinations of photosensitizer, botanical extract and light exposure against T. rubrum, which is the most common fungal species found to contribute to toenail fungus. The study identified the photosensitizer's Minimum Inhibitory Concentration (MIC), Minimum Fungicidal Concentration (MFC). Ex vivo experimental results for photosensitizer and carrier systematic treatments were also carried out to test the efficacy and safety of the treatment on human nail pieces. The results showed that the ClearToe serum showed strong nail penetration post-soaking with serum and 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 ToeFX Inc. and the Xu laboratory at McMaster University.
Below: LEFT - The white fluffy areas are growths of the fungal species T. rubrum on small pieces of a human toenail. MIDDLE = Control. RIGHT = After application of ToeFX's ClearToe serum and 15 minutes under the ClearToe Therapy LIght, there are no more white fluffy growths, indicating that the fungal colony is destroyed. Blue spots show where the ClearToe serum was applied.
ToeFX is the only photodynamic therapy treatment for onychomycosis that can be administered in 30 minutes or less.