Atopic DermatitisDetect-ADNCT07645820
Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares
An observational study of Atopic Dermatitis, run by Castle Biosciences Incorporated at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 89 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Nevisense electrical impedance spectroscopy
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 13 sitesUnited States
- Study dates
- 4 Jun 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Derm Research Institute, PLC
Caledonia, Michigan, 49316
Kristi Hawley, DO
- Recruiting
Advanced Dermatology and Cosmetic Surgery - Henderson
Henderson, Nevada, 89052
Grace (Kim) Dowty, DO, FAOCD, FAAD
- Recruiting
Las Vegas Dermatology
Las Vegas, Nevada, 89144
David Cotter, MD, PhD
- Recruiting
U.S. Dermatology Partners Lee's Summit
Lee's Summit, Missouri, 64064
Mark Fleischman, MD, FAAD
- Recruiting
DCOL Center for Clinical Research
Longview, Texas, 75605
Blake Robbins, DO
- Recruiting
James Y. Wang MD, Inc
Los Angeles, California, 90017
James Y Wang, MD
- Recruiting
Harrison Dermatology
Missouri City, Texas, 77459
Harrison Nguyen, MD, MBA, MPH, DTM&H FAAD
- Recruiting
West Virginia Research Institute
Morgantown, West Virginia, 26505
Rola Gharib, MD
- Recruiting
Virginia Clinical Research, Inc
Norfolk, Virginia, 23502
Robert Pariser, MD
- Recruiting
U.S. Dermatology Partners
Phoenix, Arizona, 85006
Margaret Kessler, MD
- Recruiting
StracSkin, PLLC
Portsmouth, New Hampshire, 03801
Abel Jarell, MD, FAAD
- Recruiting
U.S. Dermatology Partners Rockville
Rockville, Maryland, 20850
Benjamin Lockshin, MD, FAAD
- Recruiting
Jordan Valley Dermatology
South Jordan, Utah, 84095
Douglass Forsha, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Nevisense electrical impedance spectroscopy
- Keywords
- Electrical Impedance Spectroscopy, EIS, Atopic Dermatitis, Eczema, Flare, Skin barrier function, Flare Prediction, Dermatology, Nevisense Go, Skin Barrier Dysfunction
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevisense electrical impedance spectroscopyDevice
The NevisenseGo device will collect skin measurements from people with atopic dermatitis (AD) to see if it can effectively predict a flare in disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Including Eczema Area and Severity Index (EASI), Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), and body surface area (BSA).
Measured: 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.
Measured: From enrollment until end of study at 90 days
To assess the feasibility of using the Nevisense Go device.
Measured: Enrollment to Day 90 (end of study)
To assess adherence to using the Nevisense Go device.
Measured: Enrollment to Day 90 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start4 Jun 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Castle Biosciences Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SciBase AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645820
- Sponsor's protocol ID
- CBI_2026_AD_NG_Detect-AD
- Acronym
- Detect-AD
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Non-Invasive Device for Early Detection of Flares in Adults and Adolescents With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07645820
- Acronym / sponsor ID
- Detect-AD / CBI_2026_AD_NG_Detect-AD
- Conditions
- Atopic Dermatitis
- Keywords
- Electrical Impedance Spectroscopy, EIS, Atopic Dermatitis, Eczema, Flare, Skin barrier function, Flare Prediction, Dermatology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Castle Biosciences IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- SciBase AB
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nevisense electrical impedance spectroscopyThe NevisenseGo device will collect skin measurements from people with atopic dermatitis (AD) to see if it can effectively predict a flare in disease. | Device | – |
Primary outcome
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.
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
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Castle Biosciences Incorporated at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clare Johnson E VP Clinical Research (602-499-0301, cjohnson@castlebiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between skin measurements and subsequent atopic dermatitis flares (time frame: Measurements taken over 90 days, 5 days a week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.