Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
13 septembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Retiré
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Copenhagen, Danemark, 1113
- Studies&Me
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California
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Redwood City, California, États-Unis, 94063
- 450 Broadway F4
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Correlation between environmental factors and AD flare ups
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Justin M Ko, MD, MBA, study principal investigator
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 novembre 2020
Achèvement primaire (Anticipé)
31 décembre 2021
Achèvement de l'étude (Anticipé)
31 décembre 2021
Dates d'inscription aux études
Première soumission
30 juin 2021
Première soumission répondant aux critères de contrôle qualité
15 juillet 2021
Première publication (Réel)
16 juillet 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 septembre 2021
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H-19020696
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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