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Идёт набор NCT07645820

Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares

— Наблюдательное Atopic Dermatitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nevisense electrical impedance spectroscopy.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis. Базовые параметры: 12 лет — 89 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Nevisense electrical impedance spectroscopy
    The NevisenseGo device will collect skin measurements from people with atopic dermatitis (AD) to see if it can effectively predict a flare in disease.

Первичные конечные точки

  • Relationship between skin measurements and subsequent atopic dermatitis flares [Срок оценки: Measurements taken over 90 days, 5 days a week]
  • Develop and validate an algorithm using Nevisense Go EIS [Срок оценки: From enrollment until end of treatment at 90 days.]
Вторичные конечные точки (5)
  • 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: From enrollment until end of study at 90 days]
  • To assess the feasibility of using the Nevisense Go device. [Срок оценки: Enrollment to Day 90 (end of study)]
  • To assess adherence to using the Nevisense Go device. [Срок оценки: Enrollment to Day 90 (end of study)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 4 центра
  • U.S. Dermatology Partners — Phoenix
  • Las Vegas Dermatology — Las Vegas
  • StracSkin, PLLC — Portsmouth
  • Harrison Institute for Clinical Research — Missouri City

Идентификаторы

NCT: NCT07645820 · CBI_2026_AD_NG_Detect-AD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗