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Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares (Detect-AD)

2026年9月10日 更新者：Castle Biosciences Incorporated

Evaluation of a Non-Invasive Device for Early Detection of Flares in Adults and Adolescents With Atopic Dermatitis

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

450

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85006
        • 招聘中
        • U.S. Dermatology Partners
        • 首席研究员：
          • Margaret Kessler, MD
    • Maryland
      • Rockville、Maryland、美国、20850
        • 招聘中
        • U.S. Dermatology Partners Rockville
        • 首席研究员：
          • Benjamin Lockshin, MD, FAAD
    • Michigan
      • Caledonia、Michigan、美国、49316
        • 招聘中
        • Derm Research Institute, PLC
        • 首席研究员：
          • Kristi Hawley, DO
    • Missouri
      • Lee's Summit、Missouri、美国、64064
        • 招聘中
        • U.S. Dermatology Partners Lee's Summit
        • 首席研究员：
          • Mark Fleischman, MD, FAAD
    • Nevada
      • Henderson、Nevada、美国、89052
        • 招聘中
        • Advanced Dermatology and Cosmetic Surgery - Henderson
        • 首席研究员：
          • Grace (Kim) Dowty, DO, FAOCD, FAAD
      • Las Vegas、Nevada、美国、89144
        • 招聘中
        • Las Vegas Dermatology
        • 首席研究员：
          • David Cotter, MD, PhD
    • New Hampshire
      • Portsmouth、New Hampshire、美国、03801
        • 招聘中
        • StracSkin, PLLC
        • 首席研究员：
          • Abel Jarell, MD, FAAD
    • Texas
      • Missouri City、Texas、美国、77459
        • 招聘中
        • Harrison Dermatology
        • 首席研究员：
          • Harrison Nguyen, MD, MBA, MPH, DTM&H FAAD
    • Virginia
      • Norfolk、Virginia、美国、23502
        • 招聘中
        • Virginia Clinical Research, Inc
        • 首席研究员：
          • Robert Pariser, MD
    • West Virginia
      • Morgantown、West Virginia、美国、26505
        • 招聘中
        • West Virginia Research Institute
        • 首席研究员：
          • Rola Gharib, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population includes adolescents and adults aged 12 to 89 years with a documented diagnosis of atopic dermatitis and a recent history of disease flares. The multicenter design is intended to support enrollment of a demographically diverse participant population representative of individuals with atopic dermatitis in the United States.

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Relationship between skin measurements and subsequent atopic dermatitis flares
大体时间：Measurements taken over 90 days, 5 days a week
Electrical Impedance Spectroscopy (EIS) measurements collected over time to assess their relationship to subsequent participant-reported atopic dermatitis flares occurring before visible signs or symptoms are apparent.
Measurements taken over 90 days, 5 days a week
Develop and validate an algorithm using Nevisense Go EIS
大体时间：From enrollment until end of treatment at 90 days.
To develop and validate an algorithm using Nevisense Go EIS data that can calculate the momentary likelihood of AD flares, before signs or symptoms
From enrollment until end of treatment at 90 days.

次要结果测量

结果测量
措施说明
大体时间
To assess the relationship between EIS measurements of skin and AD severity through a variety of patient-reported outcome measures, including itch severity and flare frequency.
大体时间：From enrollment until end of study at 90 days
From enrollment until end of study at 90 days
To assess the relationship between EIS measurements of skin and AD severity through a variety of clinician-reported outcome measures
大体时间：From time of enrollment until end of study at 90 days.
Including Eczema Area and Severity Index (EASI), Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), and body surface area (BSA).
From time of enrollment until end of study at 90 days.
To assess the relationship between EIS measurements of skin and resolution of AD flares.
大体时间：From enrollment until end of study at 90 days
From enrollment until end of study at 90 days
To assess the feasibility of using the Nevisense Go device.
大体时间：Enrollment to Day 90 (end of study)
Enrollment to Day 90 (end of study)
To assess adherence to using the Nevisense Go device.
大体时间：Enrollment to Day 90 (end of study)
Enrollment to Day 90 (end of study)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Castle Biosciences Incorporated

合作者

SciBase AB

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月4日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CBI_2026_AD_NG_Detect-AD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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