Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Intraindividual reproducibility of measuring the natural and basal skin fluorescence
研究概览
简要总结
The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence.
This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Man and woman over 18 yers old
- •Women of childbearing age under contraceptive
- •Healthy volunteers able and willing to follow all procedures of the agreement with the study protocol.
- •Healthy volunteers affiliated to the social security
- •Ability to provide written informed consent
- •Patient's legal capacity to consent to study participation
排除标准
- •Healthy volunteers with scars or open wounds on the palms
- •Healthy volunteers with warts on their hands
- •Healthy volunteers with blister on their hands
- •Healthy volunteers involved in another clinical trial
- •Pregnant or breastfeeding women
- •People in emergencies
- •Deprived of liberty or under supervision
研究组 & 干预措施
Healthy volunteers
Healthy volunteers wash their hands with a traditional soap. Every healthy volunteers pose with palm of hand three times on the device in order to measure basal level of fluorescence of the skin.
Healthy volunteers repeated three times this procedure in order to assess the reproducibility of the measurement.
干预措施: mobile spectrofluorimeter (Device)
结局指标
主要结局
Intraindividual reproducibility of measuring the natural and basal skin fluorescence
时间窗: 1 day
The intra-individual reproducibility of measurement of natural and basal skin fluorescence will be evaluated on a healthy volunteers using a mobile spectrofluorimeter. The value of intra-class correlation coefficient will be measured by the method of Fleiss (Fleiss, 1986).
次要结局
- Demographic parameter(1 day)
- Dominant hand(1 day)
- Concomitant treatments(1 day)