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Efinaconazole 10% Topical Solution: Case Review of Onychomycosis Patients Who Were Completely Cured at Week 24.

ABSTRACT: Background:Clinical studies with topical onychomycosis agents typically involve daily application over 48 weeks. Some patients are cured earlier; however, individual data are limited. Objective:The aim of this study was to assess baseline demographics/disposition of onychomycosis patients completely cured at week 24 following daily efinaconazole treatment. Methods:We conducted a week-24 case review of 2 identical, multicenter, randomized, double-blind, vehicle-controlled studies on 1,655 patients with mild-to-moderate onychomycosis. Patients were randomized (3:1) to efinaconazole 10% solution or vehicle, once daily for 48 weeks, with a 4-week post-treatment follow-up. Complete cure was defined as 0% clinical involvement of the target toenail and mycological cure (negative KOH examination and fungal culture). Results:Overall, 19 patients had clear nails (0% clinical involvement) at week 24, and 13 (68%) were completely cured. Patients were predominantly younger (17/19 aged <65 years), female (12/19), and with recent disease (6/12). No patient had disease recurrence over the subsequent 28 weeks. Complete cure appeared independent of baseline severity. Two patients with moderate disease had clear nails by week 12, and 1 experienced recurrence. Conclusions:Efinaconazole 10% topical solution has been shown to be an effective and well-tolerated treatment for onychomycosis. Our case review highlights that some patients (typically those having faster growing, shorter nails) might expect complete cure within 24 weeks. Continued treatment appears to prevent recurrence.

SUBMITTER: Elewski BE

PROVIDER: S-EPMC5939717 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Efinaconazole 10% Topical Solution: Case Review of Onychomycosis Patients Who Were Completely Cured at Week 24.

Elewski Boni E BE Tosti Antonella A Lin Tina T

Skin appendage disorders 20170810 2

<h4>Background</h4>Clinical studies with topical onychomycosis agents typically involve daily application over 48 weeks. Some patients are cured earlier; however, individual data are limited.<h4>Objective</h4>The aim of this study was to assess baseline demographics/disposition of onychomycosis patients completely cured at week 24 following daily efinaconazole treatment.<h4>Methods</h4>We conducted a week-24 case review of 2 identical, multicenter, randomized, double-blind, vehicle-controlled st ...[more]

PMID: 29765961

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Project description:Onychomycosis is a chronic fungal infection of nails, commonly caused by dermatophyte fungi, primarily species of Trichophyton. Because of the limited drug arsenal available to treat general fungal infections and the frequent failure of onychomycosis treatment, the search for new therapeutic sources is essential, and topical treatment with natural products for onychomycosis has been encouraged. Propolis, an adhesive resinous compound produced by honeybees (Apis mellifera), has shown multiple biological properties including significant antifungal and anti-biofilm activities in vitro. In spite of promising in vitro results, in vivo results have not been reported so far. This study assessed an ethanol propolis extract (PE) as a topical therapeutic option for onychomycosis, including its characterization in vitro and its applicability as a treatment for onychomycosis (from bench to clinic). The in vitro evaluation included analysis of the cytotoxicity and the antifungal activity against the planktonic cells and biofilm formed by Trichophyton spp. We also evaluated the capacity of PE to penetrate human nails. Patients with onychomycosis received topical PE treatments, with a 6-month follow-up period. The results of the in vitro assays showed that PE was non-toxic to the cell lines tested, and efficient against both the planktonic cells and the biofilm formed by Trichophyton spp. The results also showed that PE is able to penetrate the human nail. The results for PE applied topically to treat onychomycosis were promising, with complete mycological and clinical cure of onychomycosis in 56.25% of the patients. PE is an inexpensive commercially available option, easy to obtain and monitor. Our results indicated that PE is a promising natural compound for onychomycosis treatment, due to its ability to penetrate the nail without cytotoxicity, and its good antifungal performance against species such as Trichophyton spp. that are resistant to conventional antifungals, both in vitro and in patients.

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Efinaconazole 10% Topical Solution: Case Review of Onychomycosis Patients Who Were Completely Cured at Week 24.

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Efinaconazole 10% Topical Solution: Case Review of Onychomycosis Patients Who Were Completely Cured at Week 24.

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