Efficacy of long-term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases: A multicenter, single-arm study

Ken Iozumi, Masatoshi Abe, Yoshiko Ito, Takashi Uesugi, Takashi Onoduka, Ichiro Kato, Fumihiro Kato, Kazuo Kodama, Hidetoshi Takahashi, Osamu Takeda, Koki Tomizawa, Tomoko Nomiyama, Mizue Fujii, Jun Mayama, Fumio Muramoto, Hidemi Yasuda, Kiyomitsu Yamanaka, Tomotaka Sato, Tsunao Oh-i, Hiroko KasaiRyoji Tsuboi, Naoko Hattori, Ryuji Maruyama, Tokuya Omi, Harunari Shimoyama, Yoshihiro Sei, Ichiro Nakasu, Shuhei Nishimoto, Yasuki Hata, Takashi Mochizuki, Masao Fukuzawa, Mariko Seishima, Kazumitsu Sugiura, Ichiro Katayama, Osamu Yamamoto, Masahisa Shindo, Hiroe Kiryu, Masahiro Kusuhara, Motoi Takenaka, Shinichi Watanabe

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)641-651
Number of pages11
JournalJournal of Dermatology
Volume46
Issue number8
DOIs
Publication statusPublished - 01-01-2019

Fingerprint

Onychomycosis
Nails
Drug-Related Side Effects and Adverse Reactions
Quality of Life
Incidence
Therapeutics
Safety
efinaconazole

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

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 ; Oh-i, 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. / Efficacy of long-term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases : A multicenter, single-arm study. In: Journal of Dermatology. 2019 ; Vol. 46, No. 8. pp. 641-651.
@article{5882e3eb94c245f08a9f3e5789d31c52,
title = "Efficacy of long-term treatment with efinaconazole 10{\%} solution in patients with onychomycosis, including severe cases: A multicenter, single-arm study",
abstract = "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.",
author = "Ken Iozumi and Masatoshi Abe and Yoshiko Ito and Takashi Uesugi and Takashi Onoduka and Ichiro Kato and Fumihiro Kato and Kazuo Kodama and Hidetoshi Takahashi and Osamu Takeda and Koki Tomizawa and Tomoko Nomiyama and Mizue Fujii and Jun Mayama and Fumio Muramoto and Hidemi Yasuda and Kiyomitsu Yamanaka and Tomotaka Sato and Tsunao Oh-i and Hiroko Kasai and Ryoji Tsuboi and Naoko Hattori and Ryuji Maruyama and Tokuya Omi and Harunari Shimoyama and Yoshihiro Sei and Ichiro Nakasu and Shuhei Nishimoto and Yasuki Hata and Takashi Mochizuki and Masao Fukuzawa and Mariko Seishima and Kazumitsu Sugiura and Ichiro Katayama and Osamu Yamamoto and Masahisa Shindo and Hiroe Kiryu and Masahiro Kusuhara and Motoi Takenaka and Shinichi Watanabe",
year = "2019",
month = "1",
day = "1",
doi = "10.1111/1346-8138.14935",
language = "English",
volume = "46",
pages = "641--651",
journal = "Journal of Dermatology",
issn = "0385-2407",
publisher = "Wiley-Blackwell",
number = "8",

}

Iozumi, K, Abe, M, Ito, Y, Uesugi, T, Onoduka, T, Kato, I, Kato, F, Kodama, K, Takahashi, H, Takeda, O, Tomizawa, K, Nomiyama, T, Fujii, M, Mayama, J, Muramoto, F, Yasuda, H, Yamanaka, K, Sato, T, Oh-i, T, Kasai, H, Tsuboi, R, Hattori, N, Maruyama, R, Omi, T, Shimoyama, H, Sei, Y, Nakasu, I, Nishimoto, S, Hata, Y, Mochizuki, T, Fukuzawa, M, Seishima, M, Sugiura, K, Katayama, I, Yamamoto, O, Shindo, M, Kiryu, H, Kusuhara, M, Takenaka, M & Watanabe, S 2019, 'Efficacy of long-term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases: A multicenter, single-arm study', Journal of Dermatology, vol. 46, no. 8, pp. 641-651. https://doi.org/10.1111/1346-8138.14935

Efficacy of long-term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases : A multicenter, single-arm study. / 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; Oh-i, 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.

In: Journal of Dermatology, Vol. 46, No. 8, 01.01.2019, p. 641-651.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of long-term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases

T2 - A multicenter, single-arm study

AU - Iozumi, Ken

AU - Abe, Masatoshi

AU - Ito, Yoshiko

AU - Uesugi, Takashi

AU - Onoduka, Takashi

AU - Kato, Ichiro

AU - Kato, Fumihiro

AU - Kodama, Kazuo

AU - Takahashi, Hidetoshi

AU - Takeda, Osamu

AU - Tomizawa, Koki

AU - Nomiyama, Tomoko

AU - Fujii, Mizue

AU - Mayama, Jun

AU - Muramoto, Fumio

AU - Yasuda, Hidemi

AU - Yamanaka, Kiyomitsu

AU - Sato, Tomotaka

AU - Oh-i, Tsunao

AU - Kasai, Hiroko

AU - Tsuboi, Ryoji

AU - Hattori, Naoko

AU - Maruyama, Ryuji

AU - Omi, Tokuya

AU - Shimoyama, Harunari

AU - Sei, Yoshihiro

AU - Nakasu, Ichiro

AU - Nishimoto, Shuhei

AU - Hata, Yasuki

AU - Mochizuki, Takashi

AU - Fukuzawa, Masao

AU - Seishima, Mariko

AU - Sugiura, Kazumitsu

AU - Katayama, Ichiro

AU - Yamamoto, Osamu

AU - Shindo, Masahisa

AU - Kiryu, Hiroe

AU - Kusuhara, Masahiro

AU - Takenaka, Motoi

AU - Watanabe, Shinichi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85067506582&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85067506582&partnerID=8YFLogxK

U2 - 10.1111/1346-8138.14935

DO - 10.1111/1346-8138.14935

M3 - Article

C2 - 31206779

AN - SCOPUS:85067506582

VL - 46

SP - 641

EP - 651

JO - Journal of Dermatology

JF - Journal of Dermatology

SN - 0385-2407

IS - 8

ER -