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

June 9, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • U.S. Dermatology Partners
        • Principal Investigator:
          • Margaret Kessler, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Las Vegas Dermatology
        • Principal Investigator:
          • David Cotter, MD, PhD
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • StracSkin, PLLC
        • Principal Investigator:
          • Abel Jarell, MD, FAAD
    • Texas
      • Missouri City, Texas, United States, 77459
        • Recruiting
        • Harrison Institute for Clinical Research
        • Contact:
          • Harrison Nguyen, MD, MBA, MPH, DTM&H FAAD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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.
Time Frame: 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.
Time Frame: Enrollment to Day 90 (end of study)
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)
Enrollment to Day 90 (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castle Biosciences Incorporated

Collaborators

SciBase AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 29, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBI_2026_AD_NG_Detect-AD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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