JPRN-jRCTs031220578已完成Unknown
Efficacy of Fosravuconazole, an oral antifungal agent, in the treatment of tinea pedisAn exploratory study on short-term dosing
aka Wataru0 个研究点目标入组 104 人开始时间: 2023年1月19日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 104
研究概览
简要总结
The efficacy of short-term oral foslavuconazole for 1 or 4 weeks in the treatment of tinea pedis (interdigital, vesiculobullous, and keratotic types) was confirmed. All adverse reactions occurring in this study were nonsevere and mild. Patient satisfaction with short-term oral fosravuconazole administration was also high. These results indicate that foslavuconazole is useful for short-term oral treatment of tinea pedis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •The subjects of this study will be patients with tinea pedis who meet all of the following criteria.
- •1) Patients with tinea pedis (interdigital type, vesicular type, keratotic type) on either foot or both sides of the foot.
- •(The diagnosis of tinea pedis requires confirmation of the dermatophyte element by direct speculum examination.)
- •*In patients with tinea pedis on both feet, the side with more severe clinical symptoms of tinea pedis should be selected for observation.
- •2) Patients who are at least 18 years on the date of consent
- •3) Patients with written consent to participate in the study after the details of the study have been explained to them.
- •Patients with other concurrent skin fungal infections, such as tinea cruris and tinea corporis, may be enrolled in the study. However, the concomitant diseases and their standard treatment methods will be explained to the subjects. If the subjects desire, treatment will be provided through regular medical care after the observation period.
排除标准
- •Patients with the following exclusion criteria will be excluded from the study.
- •1) Patients with a history of hypersensitivity to the drugs under study
- •2) Patients with severe eczema, erosions, maceration, abscesses, etc., on the affected area of tinea pedis requiring topical treatment other than antifungal agents
- •3) Patients with complications such as secondary infection of tinea pedis
- •4) Patients who have used oral antifungal agents within three months before the start of the study
- •5) Patients who used topical antifungal agents or topical onychomycosis agents within one month before the start of the study
- •6) Patients with hepatic impairment (or clinically problematic hepatic dysfunction), AST or ALT greater than 2.5 times the upper reference limit of the laboratory, or AST or ALT greater than 100 U/L
- •7) Patients with clinically problematic renal dysfunction, such as creatinine of 2.0 mg/dL or higher
- •8) Patients receiving warfarin
- •9) Patients suffering from serious systemic diseases (severe diabetes, autoimmune diseases such as collagen diseases, hematological diseases, and malignant tumors)
- •10) Patients receiving systemic immunosuppressive drugs (steroids, tacrolimus, cyclosporine, methotrexate, JAK inhibitors, PDE4 inhibitors, biological agents, etc.)
- •11) Pregnant or possibly pregnant patients, lactating patients, or patients who wish to become pregnant during the study period
- •12) Patients who have participated or are participating in other clinical trials or clinical studies within six months
- •13) Patients deemed ineligible for this study by the principal investigator or sub-investigator
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