Evaluation of the Efficacy and Safety of Efinaconazole 10% Topical Solution for the Treatment of Toenail Onychomycosis: A Multicenter, Single-arm, Open-label Phase 4 Study

Abstract

Background: Onychomycosis is a common nail fungal infection that affects the nail bed, plate, and matrix. It accounts for ~50% of all nail diseases. The treatment of onychomycosis includes systemic and topical approaches, which depend on patient compliance, drug penetration and delivery to the nail bed, antifungal efficacy, and tolerance. Efinaconazole is a novel triazole antifungal agent that is active against many pathogenic fungi, and is used for treating onychomycosis. Objective: To confirm the efficacy and safety of 10% efinaconazole solution for treating onychomycosis. Methods: This study was conducted as a 52-week, multicenter, open, single-group, phase 4 clinical trial. A 10% efinaconazole solution was applied on the toenails of each subject before bedtime, once a day for 48 weeks. The subjects visited the test facility every four weeks for the evaluation of the efficacy and safety of the treatment. Results: At 52 weeks of applying 10% efinaconazole solution, the rates of complete cure, mycological cure, complete or almost complete cure, and clinical effectiveness were 16.7%, 95.8%, 38.54%, and 52.1%, respectively. The clinical effects of efinaconazole were seen in more than half of the subjects. No severe adverse reactions related to efinaconazole were observed. Conclusion: The antifungal effect and safety of topically applied 10% efinaconazole solution in patients with mild to moderate toenail onychomycosis caused by dermatophytes was confirmed based on the efficacy and safety evaluation for a complete cure.