Post-Marketing Clinical Evaluation of a Manuka Oil-Based Toenail Spray (FunghiClear®), for Onychomycosis Management: Safety, Efficacy and Convenience

Introduction Onychomycosis is an often chronic fungal infection of the toenail. Conventional treatment strategies are limited due to drug interactions, side effects, lack of effectiveness, and difficulty with long-term treatment adherence, resulting in an unmet clinical need for safe and effective options suitable for long-term use. FunghiClear® is a plant-based blend with key ingredient of high-triketone Manuka oil, supported by basil, lavender and peppermint oil. The aim of this study was to assess the safety, efficacy and convenience of FunghiClear® in dermatophyte onychomycosis. Methods A 12-week study of adults aged 18-65 was undertaken in the Netherlands and Belgium, the UK, Taiwan, and Scandinavia. Participants sprayed FunghiClear® twice per day on the affected toenail(s) and surrounding skin, with standard hygiene protocol provided by their footcare professional at baseline, 6 and 12 weeks. Objective measurements of efficacy were assessed by the footcare professional through the Onychomycosis Severity Index (OSI) and a five-stage scale of Toenail Rating. Subjective measures of efficacy were assessed through perceived efficacy by the footcare professional and the participant. Safety and convenience were assessed through questionnaires. Results In total, 192 participants completed the study. After 12 weeks of using FunghiClear®, mean OSI score and Toenail Rating improved significantly. An improved OSI score was found in 129 participants (67%), while an additional 35 participants (18%) had no change in OSI. Of those that showed improved score, mean OSI improved by 8.82 points (44%), and Toenail Rating improved by 0.96 stages (44%). The mean convenience rating by participants was 4.4/5. No serious adverse events were reported, and one participant reported mild discomfort upon application. Conclusion Refocusing treatment toward long-term management and healthy nail regrowth may provide a more rounded approach to dermatophyte onychomycosis. The results of this clinical study suggest that FunghiClear®, along with standard hygiene protocol provided by footcare professional, is safe, effective and convenient to manage dermatophyte onychomycosis. This is an ongoing study with plans to expand the study and refine the protocol. This is an ongoing study with intentions to involve new participants and further extend the findings.