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NCT Number: NCT07645820

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

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.

Recruiting

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Key information

Age range

12 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

U.S. Dermatology Partners, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nevisense electrical impedance spectroscopy

Device

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 outcomes

  1. Relationship between skin measurements and subsequent atopic dermatitis flares

    Time frame: 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.

  2. Develop and validate an algorithm using Nevisense Go EIS

    Time frame: 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

Secondary outcomes

  1. 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

  2. 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.

    Including Eczema Area and Severity Index (EASI), Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), and body surface area (BSA).

  3. 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

  4. To assess the feasibility of using the Nevisense Go device.

    Time frame: Enrollment to Day 90 (end of study)

  5. To assess adherence to using the Nevisense Go device.

    Time frame: Enrollment to Day 90 (end of study)

Study contacts

Contact information is provided by the study sponsor or research team.

Clare Johnson E VP Clinical Research

CONTACT

[email protected]

602-499-0301

Sponsors and collaborators

Lead sponsor

Castle Biosciences Incorporated

Industry

Collaborators

  • SciBase AB

Registry information

Official study title

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

Acronym: Detect-AD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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