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
N1 - Funding Information:
Kaken Pharmaceutical Co., Ltd funded this study. S. W. received a consultancy fee and/or commission fee from Kaken Pharmaceutical Co., Ltd. M. F., T. S., R. T., H. S., Y. S., T. M., M. S., K. S., I. K., O. Y., M. T. and S. W. received fellowships, research grants and/or education grants from Kaken Pharmaceutical Co., Ltd. K. I., M. A., H. T., O. T., K. T., M. F., T. S., H. K., R. T., R. M., T. O., Y. S., Y. H., T. M., M. F., K. S., I. K., O. Y., M. K., M. T. and S. W. received fees as resource speakers from Kaken Pharmaceutical Co., Ltd. M. A., T. S., R. T., Y. H., T. M., M. F. and M. K. received fees for arranging education from Kaken Pharmaceutical Co., Ltd.
Publisher Copyright:
© 2019 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.
PY - 2019
Y1 - 2019
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.
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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
SN - 0385-2407
VL - 46
SP - 641
EP - 651
JO - Journal of Dermatology
JF - Journal of Dermatology
IS - 8
ER -