Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes

NCT ID: NCT04965233

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis Eczema DNA

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants recruited in Denmark

Participants recruited in Denmark will consist of 63 healthy individuals and 187 individuals with atopic dermatitis

Information reports

Intervention Type BEHAVIORAL

Reports containing general information on eczema

Participant recruited in the United States of America

Participants recruited in the US will consist of 125 healthy individuals, 3000 individuals with atopic dermatitis

DNA reports

Intervention Type BEHAVIORAL

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.

Interventions

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DNA reports

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.

Intervention Type BEHAVIORAL

Information reports

Reports containing general information on eczema

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Biotx.ai

UNKNOWN

Sponsor Role collaborator

Life&Brain

UNKNOWN

Sponsor Role collaborator

Stanford Health Care

UNKNOWN

Sponsor Role collaborator

Studies&Me

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin M Ko, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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450 Broadway F4

Redwood City, California, United States

Site Status

Studies&Me

Copenhagen, , Denmark

Site Status

Countries

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United States Denmark

Other Identifiers

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H-19020696

Identifier Type: -

Identifier Source: org_study_id

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