NCT05356572已完成不适用
A Single-center, Open, Randomized, Non-controlled, Comparative Pre-market Investigation to Evaluate the Performance of a Skin Preparation Device for Removal of Hyperkeratotic Skin
Mirka Ltd2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年9月1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
- 26
- 试验地点
- 2
- 主要终点
- Grade of hyperkeratotic skin removal
研究概览
简要总结
In this clinical one-site investigation the performance and safety of a skin preparation device will be evaluated for removing hyperkeratotic skin prior to further medical treatment. Comfort and pain during skin preparation, as well as performance and safety of device, will be compared to comparators on separate skin areas for every subject.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attending the clinic for treatment of actinic keratosis using daylight photodynamic therapy
- •Age: 18 - 100 years.
- •Available for two follow-up visits: two weeks after treatment and 4 months after treatment
- •Provision of informed consent i.e., subject must be able to understand and sign the patient Information and Consent Form
- •Subject have been informed on the nature, the scope and the relevance of the study
排除标准
- •Known or suspected allergy/hypersensitivity to phenol formaldehyde
- •Wound at the skin site to be treated
- •Documented skin disease at the time of enrollment, as judged by the investigator
- •Previously enrolled in the present investigation
- •Inclusion in other ongoing investigations simultaneously that would preclude the subject from participating in this investigation as judged by the investigator
- •Actinic keratosis treatment obtained within last 6 months
- •Involvement in the planning and conduct of the clinical investigation (applies to all investigation site staff and third party vendor)
- •Any subject that according to Medical Research Act, paragraphs 7-10, is deemed unsuitable for study enrolment.
- •Complications that would increase wound risks if investigational product would be used.
结局指标
主要结局
Grade of hyperkeratotic skin removal
时间窗: Day 0
Sufficient hyperkeratotic skin removal in comparison to comparative methods. The removal of hyperkeratotic skin is assessed visually and by palpation. Removal of hyperkeratotic skin measurement grades: All hyperkeratotic skin removed, Partial hyperkeratotic skin removed, None hyperkeratotic skin removed.
次要结局
- Subject comfort during skin preparation using a subject questionnaire(Day 0)
- Subject pain sensation during daylight photodynamic treatment(Day 0)
- Grade of skin irritation / grade of allergic skin reaction(14 day follow-up)
- Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction(Day 0)
- Duration of operation time per treated skin area(Day 0)
- Clearance of actinic keratosis(4th month follow-up)
- Subject pain sensation during skin preparation(Day 0)
- Physician comfort during skin preparation using an investigator questionnaire(Day 0)
- Presence of actinic keratosis(Day 0)
研究者
研究点 (2)
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