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. The study comprised 29 great toes followed over 6 months. 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.
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. 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.
In vitro and Ex vivo studies (2 years)
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.