Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
13 de septiembre de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Copenhagen, Dinamarca, 1113
- Studies&Me
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California
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Redwood City, California, Estados Unidos, 94063
- 450 Broadway F4
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Correlation between environmental factors and AD flare ups
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Justin M Ko, MD, MBA, study principal investigator
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de noviembre de 2020
Finalización primaria (Anticipado)
31 de diciembre de 2021
Finalización del estudio (Anticipado)
31 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
15 de julio de 2021
Publicado por primera vez (Actual)
16 de julio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-19020696
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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