Evaluation of a Non-Invasive Device for Early Detection of Flares in Adults and Adolescents With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 11
研究概览
简要总结
This study will collect skin measurements from people with atopic dermatitis (AD) using the investigational Nevisense Go device. Participants aged 12 to 89 years with a history of AD flares will use the device at home for about 90 days. Participants will complete device measurements, electronic diary entries, and up to five in-person study visits. The study is based on the idea that changes in skin barrier function may occur before an AD flare becomes visible or symptoms begin. Information collected during the study, including device measurements, diary entries, and investigator assessments, will be used to evaluate whether these changes may help estimate the likelihood of an AD flare before visible signs or symptoms occur.
详细描述
Atopic dermatitis (AD), also called eczema, is a skin condition associated with repeated periods of worsening symptoms known as flares. Researchers believe that changes in skin barrier function may occur before visible skin changes or symptoms develop. The investigational Nevisense Go device uses Electrical Impedance Spectroscopy (EIS), which measures electrical properties of the skin related to skin barrier function. Previous studies using EIS have shown associations between impedance measurements and skin barrier changes in AD. This study will collect EIS measurements from affected and unaffected skin over time to evaluate whether these measurements may help estimate the likelihood of AD flare onset before visible signs or symptoms occur. The study is observational because device measurements will not be used to guide participant treatment or clinical care during study participation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants may be eligible if they:
- •Are 12 to 89 years old.
- •Have been diagnosed with atopic dermatitis (eczema).
- •Have had at least one atopic dermatitis flare within the past 2 months.
- •Are willing and able to use the Nevisense Go device at home, complete an electronic symptom diary, and attend study visits.
- •If currently using systemic treatment for atopic dermatitis, have been on the same treatment for at least 3 months and do not plan to change treatment during the study.
排除标准
- •Participants may not be eligible if they:
- •Are unwilling or unable to avoid applying creams, lotions, ointments, or soap to measurement areas for 6 hours before measurements.
- •Do not have suitable skin areas for study measurements.
- •Have another skin condition that may affect study assessments.
- •Are pregnant.