The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adhesion time for Rivelin® plain patches
研究概览
简要总结
This explorative investigation will assess the adhesion and tolerability of the Rivelin® plain patch when applied directly on lesions in subjects with Vulvar Lichen Sclerosus (VLS).
详细描述
The Rivelin® plain patch works by forming a protective barrier over a lesion, protecting it from further irritation and thus providing pain relief in much the same way as the adhesive pastes and films that are available to treat VLS. However, the adhesion/protection time of the Rivelin® plain patch is expected to be longer compared to current treatment with bioadhesive agents, thereby potentially increasing the pain free period for the subject.
This study is undertaken to gather information covering adhesion time and tolerability of the Rivelin® plain patch on areas affected by VLS. Since protecting a lesion with a physical barrier could reduce the sensation of pain caused by normal function, this investigation will also explore subject experienced pain and/or symptom relief during use of the patch for further development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women (≥ 18 years) diagnosed with VLS
- •Has received written and oral study information
- •Has given her written consent to study participation
排除标准
- •Menstruating at the time of patch application
- •Unable to communicate clearly with the examining doctors
- •Under the guardianship of another person or institution
研究组 & 干预措施
Rivelin® plain patches
This is an open label study with the objectives to establish information on adhesion time, tolerability and usability of Rivelin® plain patches when applied to VLS lesions. Furthermore, the design of the Rivelin® plain patch will also be evaluated.
干预措施: Rivelin® plain patches (Device)
结局指标
主要结局
Adhesion time for Rivelin® plain patches
时间窗: 2 days
The proportion of successful applications of Rivelin® plain patches (defined as an adhesion time ≥ 30 min); separate summaries for morning and evening applications
次要结局
- Adverse Events(2 days)
- Ability to apply patches correctly(2 days)
- Understanding of the Instructions for use leaflet(2 days)
- Optimising the design of the patch(2 days)
- Visual analogue scale (VAS) scores(2 days)