NCT02798380已完成2 期
An Open-Label Phase 2 Study to Investigate the Efficacy, Tolerability, and Safety of the HTS-519 Insert in the Treatment of Subjects With Distal Lateral Subungual Onychomycosis of the Great Toenail
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Hallux, Inc.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment Related Adverse Events
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519 Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.
详细描述
Open label, single-site
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females 18 - 74 years of age inclusive
- •Fungal toenail infection of one or both of the large (great) toenails
- •The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
- •Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit
排除标准
- •History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition
- •Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved
- •Significant confounding conditions as assessed by the study doctor
- •Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- •No administration of systemic antifungal medications within 6 months prior to screening visit
- •No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
- •Tinea pedis (athlete's foot) that would require systemic treatment
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
HTS-519 Insert
Experimental
Active treatment
干预措施: HTS-519 Insert (Drug)
结局指标
主要结局
Treatment Related Adverse Events
时间窗: Up to 48 weeks
Frequency and severity of Treatment Related Adverse Events
次要结局
未报告次要终点
研究者
研究点 (1)
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