NCT03280927已完成4 期
A Multicenter, Open-label, Non-controlled, Single-arm Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Completely cured subjects
研究概览
简要总结
The antifungal efficacy and safety of Jublia® topical solution will be assessed through an administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due to dermatophyte.
详细描述
Evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate toenail onychomycosis caused by dermatophytes that received a 48-week administration of efinaconazole.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects of ages in the range over
- •The subjects diagnosed with onychomycosis in up to 6 toenails at least
- •1 great toenail woth no fingernails
- •The subjects diagnosed with a mild to moderate onychomycosis (20% to 50% of surface of target nail without nail matrix infection or dermatophytoma)
- •The subjects having target nails less than 3mm in thickness and over 3mm in length
- •Positive indication on KOH Direct Microscopic Inspection on target nail
- •Positive dermatophyte or dermatophyte/candida on Fungi Cultivation Inspection on target nail
- •The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent.
排除标准
- •The subjects suffering other diseases that may cause nail abnormalities or are supposed to be affecting the assessment of the efficacy of study agent by the judgment of investigators
- •The subjects having a case history of hypersensitivity reaction to the component of Jublia® topical solution or Azole derivatives.
- •The pregnant, lactating, or fertile woman free from pertinent contraception
研究组 & 干预措施
Jublia®
Experimental
干预措施: Jublia® (Drug)
结局指标
主要结局
Completely cured subjects
时间窗: 52 weeks
The ratio of completely cured subjects
次要结局
- Complete or almost complete cure rates(52 weeks)
- Mycologic cure rates(52 weeks)
- Clinical efficacy rates(52 weeks)
研究者
研究点 (1)
Loading locations...
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