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

10 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Atopische dermatitis

Interventie / Behandeling

Apparaat: Nevisense electrical impedance spectroscopy

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

450

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Clare Johnson E VP Clinical Research
Telefoonnummer: 602-499-0301
E-mail: cjohnson@castlebiosciences.com

Studie Locaties

Verenigde Staten
- Arizona
  - Phoenix, Arizona, Verenigde Staten, 85006
    - Werving
    - U.S. Dermatology Partners
    - Hoofdonderzoeker:
      
      Margaret Kessler, MD
- Maryland
  - Rockville, Maryland, Verenigde Staten, 20850
    - Werving
    - U.S. Dermatology Partners Rockville
    - Hoofdonderzoeker:
      
      Benjamin Lockshin, MD, FAAD
- Michigan
  - Caledonia, Michigan, Verenigde Staten, 49316
    - Werving
    - Derm Research Institute, PLC
    - Hoofdonderzoeker:
      
      Kristi Hawley, DO
- Missouri
  - Lee's Summit, Missouri, Verenigde Staten, 64064
    - Werving
    - U.S. Dermatology Partners Lee's Summit
    - Hoofdonderzoeker:
      
      Mark Fleischman, MD, FAAD
- Nevada
  - Henderson, Nevada, Verenigde Staten, 89052
    - Werving
    - Advanced Dermatology and Cosmetic Surgery - Henderson
    - Hoofdonderzoeker:
      
      Grace (Kim) Dowty, DO, FAOCD, FAAD
  - Las Vegas, Nevada, Verenigde Staten, 89144
    - Werving
    - Las Vegas Dermatology
    - Hoofdonderzoeker:
      
      David Cotter, MD, PhD
- New Hampshire
  - Portsmouth, New Hampshire, Verenigde Staten, 03801
    - Werving
    - StracSkin, PLLC
    - Hoofdonderzoeker:
      
      Abel Jarell, MD, FAAD
- Texas
  - Missouri City, Texas, Verenigde Staten, 77459
    - Werving
    - Harrison Dermatology
    - Hoofdonderzoeker:
      
      Harrison Nguyen, MD, MBA, MPH, DTM&H FAAD
- Virginia
  - Norfolk, Virginia, Verenigde Staten, 23502
    - Werving
    - Virginia Clinical Research, Inc
    - Hoofdonderzoeker:
      
      Robert Pariser, MD
- West Virginia
  - Morgantown, West Virginia, Verenigde Staten, 26505
    - Werving
    - West Virginia Research Institute
    - Hoofdonderzoeker:
      
      Rola Gharib, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Relationship between skin measurements and subsequent atopic dermatitis flares Tijdsspanne: 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 Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
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. Tijdsspanne: 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 Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: Enrollment to Day 90 (end of study)		Enrollment to Day 90 (end of study)
To assess adherence to using the Nevisense Go device. Tijdsspanne: Enrollment to Day 90 (end of study)		Enrollment to Day 90 (end of study)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Castle Biosciences Incorporated

Medewerkers

SciBase AB

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 juni 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria