Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

10 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Atopisk dermatit

Intervention / Behandling

Enhet: Nevisense electrical impedance spectroscopy

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

450

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Clare Johnson E VP Clinical Research
Telefonnummer: 602-499-0301
E-post: cjohnson@castlebiosciences.com

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Relationship between skin measurements and subsequent atopic dermatitis flares Tidsram: 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 Tidsram: 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.

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
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. Tidsram: 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 Tidsram: 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. Tidsram: 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. Tidsram: Enrollment to Day 90 (end of study)		Enrollment to Day 90 (end of study)
To assess adherence to using the Nevisense Go device. Tidsram: Enrollment to Day 90 (end of study)		Enrollment to Day 90 (end of study)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Castle Biosciences Incorporated

Samarbetspartners

SciBase AB

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 juni 2026

Primärt slutförande (Beräknad)

1 april 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna