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

10. september 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

450

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relationship between skin measurements and subsequent atopic dermatitis flares
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: Enrollment to Day 90 (end of study)
Enrollment to Day 90 (end of study)
To assess adherence to using the Nevisense Go device.
Tidsramme: Enrollment to Day 90 (end of study)
Enrollment to Day 90 (end of study)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Castle Biosciences Incorporated

Samarbeidspartnere

SciBase AB

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. juni 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CBI_2026_AD_NG_Detect-AD

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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