NCT04601259已完成不适用
A Prospective, Randomized, Controlled, Open-labelled Investigation to Assess Performance and Safety of Orkla Corn Plaster
Orkla Care AB2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年10月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
研究概览
简要总结
This is a prospective, randomized, controlled, open-labelled investigation to assess performance and safety of Orkla Corn Plaster in subject with corns. The hypothesis is that there is an improvement in the size of corns at day 28 compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •>18 years of age
- •Presence of corn(s) confirmed by Investigator
- •Corn included into investigation shall not have been subject to any other treatment 1 month prior to study enrolment.
排除标准
- •Pregnant or lactating women at time of enrolment
- •Subjects with hypersensitivity to salicylic acid/salicylates, polyethylene foil, acrylic adhesive, viscose/polyethylene fibers and azorubine
- •Subjects diagnosed with diabetes
- •Subjects with poor peripheral blood circulation
- •Subjects with renal dysfunction (eGFR <60 mL/min/1.73 m2)
- •Subjects with ongoing skin disease in the area where the index corn is located.
- •Subjects with any other condition that as judged by the investigator may make follow-up or investigations procedures inappropriate
- •Any subject that according to the Declaration of Helsinki is unsuitable for enrollment
结局指标
主要结局
Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
时间窗: 28 days
次要结局
- Resolution of corn at D14, D28, 3 and 6 months(14 days, 28 days, 3 months and 6 months)
- Difference in percentage of improved subjects from D0 (baseline) to D28 between Orkla Corn Plaster (with salicylic acid) and Orkla Corn Protector (without salicylic acid)(28 days)
- Percentage of improved subjects at D14, 3 and 6 months compared to baseline.(14 days, 3 months and 6 months)
- Pain assessment recorded on Visual Analog Scale (VAS; scale: 0-100 mm where a higher score corresponds to worse pain) before and immediately after plaster application(Before and immediately after plaster application)
- Usability questionnaire: Adherence to the application site assessed via subject-reported question with a 5-point qualitative scale.(14 days, 28 days)
- Percentage of subjects with recurrence at D14, D28, 3 and 6 months(14 days, 28 days, 3 months and 6 months)
- Corn size reduction (mm) at D14, D28, 3 and 6 months(14 days, 28 days, 3 months and 6 months)
- Subject treatment satisfaction questionnaire: Overall treatment satisfaction assessed via subject-reported question with a 5-point qualitative scale(28 days)
- Subject treatment satisfaction questionnaire: Product recommendation assessed via subject-reported question with answer alternatives Yes/No/Don't know(28 days)
- Investigator treatment satisfaction questionnaire: Product recommendation assessed via investigator-reported questionnaire with answer alternatives Yes/No/Don't know(28 days)
- Pain experienced from index corn recorded on Visual Analog Scale (VAS; scale: 0-100 mm where a higher score corresponds to worse pain) at D14, D28, 3 and 6 months compared to baseline.(14 days, 28 days, 3 months and 6 months)
- Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale(28 days)
- Subject reported resolution point of time (diary)(Up to 6 months)
- Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.(14 days, 28 days)
- Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale(28 days)
- Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale(28 days)
研究者
研究点 (2)
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