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Recruiting NCT07645820

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

— Observational Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nevisense electrical impedance spectroscopy.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: 12 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device 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.

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

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

Identifiers

NCT: NCT07645820 · CBI_2026_AD_NG_Detect-AD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗