J Mycol Infect.  2021 Jun;26(2):35-44. 10.17966/JMI.2021.26.2.35.

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

Affiliations
  • 1Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea
  • 2Department of Dermatology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 3Department of Dermatology, School of Medicine, Catholic University of Daegu, Daegu, Korea
  • 4Department of Dermatology, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 5Department of Dermatology, College of Medicine, Yeungnam University, Daegu, Korea
  • 6Department of Dermatology, College of Medicine, Inje University, Busan, Korea
  • 7Departments of Dermatology, Chonnam National University Medical School, Gwangju, Korea
  • 8Department of Dermatology, Jeonbuk National University Medical School, Jeonju, Korea
  • 9Departments of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea
  • 10Research Institute of Medical Science, Konkuk University, Seoul, Korea Korea

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.

Keyword

Dermatophyte; Efinaconazole; Onychomycosis; Toenail
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