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, Kyozo; Sato, Tomotaka; T, Ohi; Kasai, Hiroko; Tsuboi, Ryoji; Hattori, Naoko; Maruyama, Ryuji; Omi, Tokuya; Shimoyama, Harunari; Sei, Yoshihiro; Nakasu, Ichiro; Nishimoto, Shuhei; Hata, Yoshinobu; Mochizuki, Takashi; Fukuzawa, Masao; Seishima, Mariko; Sugiura, Kazumitsu; Katayama, Ichiro; Yamamoto, Osamu; Shindo, Masahisa; Kiryu, Hiroe; Kusuhara, Masahiro; Takenaka, Motoi; Watanabe, Shinichi

doi:10.1111/1346-8138.14935

Cited by 28 publications

(26 citation statements)

References 22 publications

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“…To evaluate the efficacy and safety of long‐term use (up to 72 weeks), a single‐arm open study ( n = 219) including severe cases (>50% affected nail area) was conducted in Japan 71 . According to the report, at week 72 the complete cure rate was 31.1%, mycological cure rate was 61.6% and treatment success (<10% clinical involvement of the target nail) was 56.6% 71 . The results of these studies demonstrated that continuous application contributed to the improvement of the cure rate.…”

Section: Cq3: Is Topical Efinaconazole 10% Solution Recommended For Tinea Unguium Treatment?mentioning

confidence: 99%

Guidelines for the management of dermatomycosis (2019)

Mochizuki

Tsuboi

Iozumi

et al. 2020

The Journal of Dermatology

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The "Guidelines for the management of dermatomycosis" of the Japanese Dermatological Association were first published in Japanese in 2009 and the Guidelines Committee of the Japanese Dermatological Association revised it in 2019. The first guidelines was prepared according to the opinions of the Guidelines Committee members and it was of educational value. The revised version is composed of introductory descriptions of the disease concepts, diagnosis, medical mycology and recent advances in treatment, along with clinical questions (CQ), which is intended to help in general practice for dermatologists. The CQ are limited to those involved in therapy but include some of the recently launched antifungal agents. The level of evidence and the degree of recommendation for each item were reviewed by the committee based on clinical studies published by 2018. For rare dermatomycoses, recommendations by the committee are described in the guidelines. In this field, there are still few good quality studies on treatment. Periodic revision in line with new evidence is necessary.

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Section: Cq3: Is Topical Efinaconazole 10% Solution Recommended For Tinea Unguium Treatment?mentioning

confidence: 99%

Guidelines for the management of dermatomycosis (2019)

Mochizuki

Tsuboi

Iozumi

et al. 2020

The Journal of Dermatology

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“…In the last years, the new antifungal agent efinaconazole (EFI), a triazole drug that inhibits fungal lanosterol 14 α-demethylase involved in the biosynthesis of ergosterol, has been introduced in the market for the treatment of onychomycosis. EFI displays a broad spectrum of in vitro activity against dermatophytes, nondermatophyte molds, and yeasts, showing a more potent antimicrobial activity than the currently marketed antifungal agents (8–10).…”

Section: Introductionmentioning

confidence: 99%

Ciclopirox and Efinaconazole Transungual Permeation, Antifungal Activity, and Proficiency To Induce Resistance in Trichophyton rubrum

Monti

Mazzantini

Tampucci

et al. 2019

Antimicrob Agents Chemother

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Onychomycosis is a nail fungal infection, mostly caused by dermatophytes. The treatment efficacy is impaired by difficulties of reaching effective drug levels at the site of infection; frequent relapses occur after cessation of antifungal therapy. The aim of the study was to compare two commercial products containing ciclopirox or efinaconazole for antimycotic activity and antifungal drug resistance. A study of permeation and penetration through bovine hoof membranes, as a nail model, was performed to evaluate the antimycotic activity of permeates against clinical isolates of selected fungi, and the frequency of spontaneous in vitro Trichophyton rubrum-resistant strains was assessed by broth microdilution assays. The results suggest that ciclopirox creates a depot in the nail, leading to a gradual release of the drug over time with action on both the nail plate and bed. Conversely, efinaconazole, mildly interacting with nail keratin, mainly exerts its antifungal activity in the nail bed. However, in the case of T. rubrum, the antifungal activities of the drugs in the nail plate seem comparable. Finally, efinaconazole showed a potential for induction of resistance in T. rubrum, which may limit its efficacy over time. Ciclopirox did not show any potential to induce resistance in T. rubrum and appears endowed with a more complete activity than efinaconazole in the management of onychomycosis as the nail keratin is a substrate for the growth of fungal cells, and the availability of drug in large concentration just in the nail bed may not be sufficient to guarantee the complete eradication of pathogens.

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“…For itraconazole pulse therapy (400 mg/day), the clinical and complete cure rates at 72 weeks with 3 courses were 31.8% and 23.4%, respectively, and 32.1% and 25.9% (28/108), respectively, for 4 courses [20]. The reported complete cure rate with topical agents is approximately 30-40%, and a long period of administration is required for achieving complete cure [8][9][10]. In terms of the complete cure rate, our study achieved excellent results.…”

Section: Discussionmentioning

confidence: 99%

“…Since 2010, two topical antifungal agents, e naconazole 10% solution and luliconazole 5% solution, have been approved for the treatment of onychomycosis in Japan. Compared with systemic therapy, topical agents are not associated with serious adverse events and can be applied safely, but they are not as effective as systemic therapies [8][9][10]. In addition, complete cure can take considerable time [10].…”

Section: Introductionmentioning

confidence: 99%

Treatment Outcome With Fosravuconazole L-lysine Ethanolate (F-RVCZ) for Onychomycosis

Shimoyama

Sei

et al. 2021

Preprint

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Fosravuconazole L-lysine ethanolate (F-RVCZ), a ravuconazole prodrug, is a newly available agent with high expectations for efficacy in the treatment of onychomycosis. However, clinical data regarding the efficacy of F-RVCZ are limited because the drug was launched only in Japan in 2018. Therefore, we analyzed the outcome of F-RVCZ therapy in the treatment of onychomycosis at outpatient dermatology clinics in Japan. We examined data for 109 patients (68 male, 41 female) with varying clinical type, including total dystrophic onychomycosis and dermatophytoma, and a wide range of age groups, including the elderly. The complete cure rate at 12 weeks was 6.4% (7/109) and 67.9% (74/109) at the last visit (mean time to last visit: 32±14.2 weeks). Mean rate of improvement in the affected nail area was 49.1±23.3% at 12 weeks and 86.8±22.4% at the last visit. Efficacy at 12 weeks and the last visit, respectively, was as follows: none, 4 cases and 1 case; slight, 35 cases and 4 cases; moderate, 51 cases and 21 cases; significant, 12 cases and 9 cases; complete cure, 7 cases and 74 cases. There were no serious adverse events. This retrospective survey was the first large-scale analysis of actual clinical practice outcomes and had minimal exclusions. Compared to previous reports, our results demonstrated excellent efficacy of F-RVCZ therapy in a variety of patients. Considering our results and the ease of oral administration (1 capsule/day for 12 weeks) and few adverse events, F-RVCZ therapy appears to be a useful option for the treatment of onychomycosis.

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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

Cited by 28 publications

References 22 publications

Guidelines for the management of dermatomycosis (2019)

Guidelines for the management of dermatomycosis (2019)

Ciclopirox and Efinaconazole Transungual Permeation, Antifungal Activity, and Proficiency To Induce Resistance in Trichophyton rubrum

Treatment Outcome With Fosravuconazole L-lysine Ethanolate (F-RVCZ) for Onychomycosis

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