Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
13. september 2021 oppdatert av: Studies&Me
Atopic eczema is a common skin disorder affecting at least 2-3% of the western population.
Atopic eczema cannot be cured and therefore treatment aims to alleviate the symptoms of the disease.
Today, many different medical treatments are available: from mild hormone creams to harsh systemic treatments.
The treatment chosen depends in part on the severity of the eczema and on the treatment response of the individual.
This practice may mean that some people with eczema undergo unnecessary treatment courses with associated side effects.
We know today that eczema has a hereditary component, and different areas have been identified in the hereditary material that appear to play a role.
Although it is thought that variations in specific areas of the inheritance material may influence how eczema is expressed in the individual, the significance of these variations is far from clarified.
The investigators want to increase the knowledge about atopic eczema, about the disease and how in the future we can organize the treatment of eczema based on knowledge of our genetic material.
In this study, the investigators want to elucidate whether there is a correlation between specific variations in the genetic material and how the eczema is clinically expressed.
In addition, the investigators want to assess whether reports with specific information about the individual's genetic material in relation to his or her lifestyle can help retain participants in research projects.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Copenhagen, Danmark, 1113
- Studies&Me
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California
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Redwood City, California, Forente stater, 94063
- 450 Broadway F4
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Recruitment is performed through the Studies&Me platform (https://studiesandme.com/), which is recruiting and screening people with AD, who are generally interested in participating in a study related to their disease.
Participants will also be recruited through clinics and hospitals.
Beskrivelse
Inclusion Criteria:
- Informed consent has been signed
- 18 years or older
- Resident in the USA or Denmark
- AD meeting the UK Diagnostic Criteria for Atopic Dermatitis
- At least one visible AD lesion at the time of recruitment (as confirmed remotely through photo upload in screening)
- Smartphone user with daily access to internet (WIFI or 3G/4G)
- Willing to donate a DNA sample
- Confirmed intention to comply with study protocol procedures
Exclusion Criteria:
- Female subjects that are pregnant (or plan to become so during the study period) or lactating
- Active dermatological condition that may confound the diagnosis of AD and/or the assessment of disease activity
- Unable to speak or understand English or Danish
- Overlap with participation in interventional trials
- No visible AD at time of screening
- Any other reasons that in the investigator's opinion could:
- Impede a subject's ability to complete the study period
- Influence the objectivity or quality of the findings of the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Participants recruited in Denmark
Participants recruited in Denmark will consist of 63 healthy individuals and 187 individuals with atopic dermatitis
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Reports containing general information on eczema
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Participant recruited in the United States of America
Participants recruited in the US will consist of 125 healthy individuals, 3000 individuals with atopic dermatitis
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The personalized DNA lifestyle reports cover the following topics: Healthy weight, Vitamin D, Alcohol, Lactose, Injuries, Caffeine, Fitness, Carbohydrates, The mind, Vitamin B, The senses, and Omega.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in AD phenotype measured on a weekly basis for 12 weeks using the SCORing Atopic Dermatitis (SCORAD) evaluated remotely through photos by investigator assessment.
Tidsramme: 12 weeks
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SCORAD measures the severity of eczema on a scale from 0-103.
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12 weeks
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Change in AD phenotype measured on a weekly basis for 12 weeks using the Three Item Severity Score (TIS) evaluated remotely through photos by investigator assessment.
Tidsramme: 12 weeks
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TIS measures the severity of erythema, oedema/papulation and excoriation on a scale from 0-9.
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12 weeks
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Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema Area and Severity Index (EASI) evaluated remotely through photos by investigator assessment.
Tidsramme: 12 weeks
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EASI measures the severity and body surface area of eczema on a scale from 0-72.
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12 weeks
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Change in AD phenotype measured on a weekly basis for 12 weeks using the The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)) evaluated remotely through photos by investigator assessment.
Tidsramme: 12 weeks
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vIGA-AD measures the severity of eczema on a scale from 0-4.
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12 weeks
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Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient Oriented Eczema Measurement (POEM) questionnaire.
Tidsramme: 12 weeks
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POEM measures the severity of eczema as experienced by the patient on a scale from 0-28.
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12 weeks
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Change in AD phenotype measured on a weekly basis for 12 weeks using the Skindex-mini questionnaire.
Tidsramme: 12 weeks
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Skindex-mini measures the symptomatic, emotional and functional aspects of an individual's skin disorder on a scale from 0-18.
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12 weeks
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Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient's Global Impression of Severity Numerical Rating System (PGIS-NRS) questionnaire.
Tidsramme: 12 weeks
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PGIS-NRS measures the impression of severity of an individual's skin disorder on a scale from 0-10.
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12 weeks
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Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema-related sleep quality NRS questionnaire.
Tidsramme: 12 weeks
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Eczema-related sleep quality NRS measures the sleep quality, itch and dryness on a scale from 0-10.
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12 weeks
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Change in AD phenotype measured by patient-perceived flare ups on a weekly basis for 12 weeks.
Tidsramme: 12 weeks
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Number of days on a weekly basis with flare ups.
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12 weeks
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Change in AD phenotype measured by the disease extent method on a weekly basis for 12 weeks.
Tidsramme: 12 weeks
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Palm method to measure AD affected body surface area (0-100%).
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12 weeks
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Change in AD phenotype measured by the Eczema Area and Severity Index (EASI) on a weekly basis for 12 weeks.
Tidsramme: 12 weeks
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EASI measures the severity and body surface area of eczema on a scale from 0-72.
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12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
Tidsramme: 12 weeks
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Number of completers receiving DNA lifestyle reports/information reports at different time points will be compared to evaluate effect on retention.
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12 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Correlation between environmental factors and AD flare ups
Tidsramme: 12 weeks
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Passive data on geographical localisation, daily activity level and an approximation for length of sleep
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12 weeks
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Number of days on a weekly cycle of patient-use of medication/treatment
Tidsramme: 12 weeks
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Number of days on a weekly cycle of patient-use of medication/treatment
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12 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Justin M Ko, MD, MBA, study principal investigator
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)
30. november 2020
Primær fullføring (Forventet)
31. desember 2021
Studiet fullført (Forventet)
31. desember 2021
Datoer for studieregistrering
Først innsendt
30. juni 2021
Først innsendt som oppfylte QC-kriteriene
15. juli 2021
Først lagt ut (Faktiske)
16. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-19020696
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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