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Efficacy of long‐term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases: A multicenter, single‐arm study
Author(s) -
Iozumi Ken,
Abe Masatoshi,
Ito Yoshiko,
Uesugi Takashi,
Onoduka Takashi,
Kato Ichiro,
Kato Fumihiro,
Kodama Kazuo,
Takahashi Hidetoshi,
Takeda Osamu,
Tomizawa Koki,
Nomiyama Tomoko,
Fujii Mizue,
Mayama Jun,
Muramoto Fumio,
Yasuda Hidemi,
Yamanaka Kiyomitsu,
Sato Tomotaka,
Ohi Tsunao,
Kasai Hiroko,
Tsuboi Ryoji,
Hattori Naoko,
Maruyama Ryuji,
Omi Tokuya,
Shimoyama Harunari,
Sei Yoshihiro,
Nakasu Ichiro,
Nishimoto Shuhei,
Hata Yasuki,
Mochizuki Takashi,
Fukuzawa Masao,
Seishima Mariko,
Sugiura Kazumitsu,
Katayama Ichiro,
Yamamoto Osamu,
Shindo Masahisa,
Kiryu Hiroe,
Kusuhara Masahiro,
Takenaka Motoi,
Watanabe Shinichi
Publication year - 2019
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/1346-8138.14935
Subject(s) - medicine , adverse effect , cure rate , dermatology , incidence (geometry) , quality of life (healthcare) , clinical efficacy , clinical endpoint , adverse drug reaction , surgery , drug , clinical trial , pharmacology , physics , nursing , optics
We evaluated the efficacy of efinaconazole 10% topical solution in long‐term use, for up to 72 weeks, for onychomycosis, including severe cases. Among 605 participants, 219 patients diagnosed as having onychomycosis were evaluated for the efficacy of efinaconazole. The treatment success rate (<10% clinical involvement of the target toenail) at the final assessment time point was 56.6%, the complete cure rate was 31.1% and the mycological cure rate was 61.6%, all of which increased over time, demonstrating that continuous application contributed to the improvement of cure rate. Even in severe cases, reduction of the affected nail area was observed, showing the potential efficacy of the treatment. Responses to a quality of life questionnaire among patients with onychomycosis, OnyCOE‐t, suggested that efinaconazole treatment improved the patients’ quality of life. The incidence of adverse drug reaction in the patients eligible for the assessment was 6.3%, and this developed only in the administration site in all cases. No systemic adverse event was observed. In addition, no increase in the incidence of adverse drug reaction due to long‐term use was found. Efinaconazole therapy was proved to exhibit excellent balance between efficacy and safety, and thus may serve as a useful treatment option for onychomycosis.