Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
13 september 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Studietype
Observationeel
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Copenhagen, Denemarken, 1113
- Studies&Me
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California
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Redwood City, California, Verenigde Staten, 94063
- 450 Broadway F4
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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
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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
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
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Correlation between environmental factors and AD flare ups
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Justin M Ko, MD, MBA, study principal investigator
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)
30 november 2020
Primaire voltooiing (Verwacht)
31 december 2021
Studie voltooiing (Verwacht)
31 december 2021
Studieregistratiedata
Eerst ingediend
30 juni 2021
Eerst ingediend dat voldeed aan de QC-criteria
15 juli 2021
Eerst geplaatst (Werkelijk)
16 juli 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 september 2021
Laatste update ingediend die voldeed aan QC-criteria
13 september 2021
Laatst geverifieerd
1 september 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-19020696
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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