A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage reduction of the surface area of infection over time using image analysis
研究概览
简要总结
This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis.
The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product.
The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. This will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. Both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent has been obtained.
- •Age between 18 years to 65 years inclusive.
- •Gender: male and female subjects.
- •Subjects with visual signs of MILD fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment.
- •Subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist.
排除标准
- •Subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment.
- •Subjects with fungal nail infection on more than two toenails on their target foot.
- •Subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.
结局指标
主要结局
Percentage reduction of the surface area of infection over time using image analysis
时间窗: 40 weeks
次要结局
- The proportion of subjects whose fungal nail infection has resolved(40 weeks)
- Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis(4 weeks)