NCT07065773进行中（未招募）2 期
An Open Label Study to Investigate the Safety and Tolerability of Trichostatin A in Patients With Mild to Severe Onychomycosis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution. The efficacy objectives of the study will be assessed using fungal culture testing, Neutral Red Staining (NRS) microscopy examination, and KOH microscopy examination after 4 weeks of treatment with VTR-297.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to provide signed and dated written voluntary informed consent.
- •Adults with diagnosis of mild-to-severe DLSO/DSO affecting at least one great toenail.
- •Positive microscopic examination with KOH for dermatophyte hyphae.
- •Positive dermatophyte culture or mixed dermatophyte/Candida culture.
排除标准
- •Presence of other toenail infection.
- •Any disease or condition that may interfere with the evaluation including other conditions that affect the toenails or significant active tinea pedis.
- •History of other significant chronic fungal disease, psoriasis, lichen planus or use of drug medications for those indications 6 months prior to screening and during the study.
- •Participation in a previous clinical trial 3 months prior to screening or participation in a research study concurrent with this study.
- •Current or planned pregnancy during the trial period.
研究组 & 干预措施
Trichostatin A
Experimental
干预措施: Trichostatin A (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 24 weeks
Subjects will be asked about AEs weekly during the evaluation phase and at every follow-up visit; descriptions of AEs will include, at a minimum: date of onset, date ended, severity, seriousness, relationship to the study drug, and outcome.
次要结局
未报告次要终点
研究者
研究点 (5)
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