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

NCT07645820 | Recruiting FDA Device

• 1 other identifier: CBI_2026_AD_NG_Detect-AD
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Electrical Impedance Spectroscopy; EIS; Atopic Dermatitis; Eczema; Flare; Skin barrier function; Flare Prediction; Dermatology; Nevisense Go; Skin Barrier Dysfunction

Outcome Measures

Primary Outcomes (2)

• Relationship between skin measurements and subsequent atopic dermatitis flares

  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

  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 Outcomes (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.

  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

  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.

  From enrollment until end of study at 90 days

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

  Enrollment to Day 90 (end of study)

• To assess adherence to using the Nevisense Go device.

  Enrollment to Day 90 (end of study)

Interventions

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.

Eligibility Criteria

• Age: 12 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Castle Biosciences Incorporated: lead
• SciBase AB: collaborator

Study Sites (4)

U.S. Dermatology Partners

Phoenix, Arizona, 85006, United States

RECRUITING

Las Vegas Dermatology

Las Vegas, Nevada, 89144, United States

RECRUITING

StracSkin, PLLC

Portsmouth, New Hampshire, 03801, United States

RECRUITING

Harrison Institute for Clinical Research

Missouri City, Texas, 77459, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Clare Johnson E VP Clinical Research

CONTACT

602-499-0301; cjohnson@castlebiosciences.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)