JPRN-jRCTs031200047Completed未知
Examination of the usefulness of additional treatment after oral antifungal treatment aiming at complete cure of Onychomycosis.
aka Wataru0 sites318 target enrollmentStarted: June 8, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 318
Study Overview
Brief Summary
For refractory onychomycosis with an improvement in the opacity ratio of less than 55% at the first 24 weeks of treatment, additional treatment with foslavuconazole can improve the cure rate.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1) Patients who are affected with onychomycosis on the first toenail of either the left or right
- •2) Patients with opacity ratio of opacity lesion of the first toe nail are 5 or more
- •3) Patients aged at least 20 years of age at the consent day
- •4) Patients who provided written consent for participation in the study
Exclusion Criteria
- •1) Patients with a known hypersensitivity to any excipients of the study drugs
- •2) When the target toenail is classified into the below subtypes Wedge shape
- •Total dystrophic onychomycosis (TDO)
- •Superficial white onychomycosis (SWO)
- •Proximal subungual onychomycosis (PSO)
- •3) When the target toenail is extremely thickened or deformed
- •4) Patients who had or have diagnosed as psoriasis, palmoplantar pustulosis
- •5) Patients with dermatological diseases (exp: lichen planus) showing thickened or involved toenails.
- •6) Patients who received oral or topical anti-onychomycotic drugs within 3 months before the first administration of the study drug
- •7) Patients who received topical anti-fungal drugs within a month before the first administration of the study drug
- •8) Patients with hepatic disorder (or show clinically important impairment of liver function), or who show AST or ALT more than 2.5 times higher values compared to the upper limit of normal values or who show AST or ALT more than 100U/L.
- •9) Patients who are receiving warfarin
- •10) Pregnant or possibly pregnant women, breastfeeding women, or women who wish to become pregnant during the study
- •11) Patients who are participating or participated into other clinical studies in the past 6 months
- •12) Patients that it is judged by the investigators that participation into this study is inappropriate
Investigators
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