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

Withdrawn

• Conditions: DNA; Eczema; Atopic Dermatitis
• Interventions: Behavioral: Information reports; Behavioral: DNA reports

• Registration Number: NCT04965233
• Lead Sponsor: Studies&Me

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants recruited in Denmark	Information reports	Participants recruited in Denmark will consist of 63 healthy individuals and 187 individuals with atopic dermatitis
Participant recruited in the United States of America	DNA reports	Participants recruited in the US will consist of 125 healthy individuals, 3000 individuals with atopic dermatitis

Primary Outcome Measures

Name	Time	Method
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.	12 weeks	SCORAD measures the severity of eczema on a scale from 0-103.
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.	12 weeks	TIS measures the severity of erythema, oedema/papulation and excoriation on a scale from 0-9.
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.	12 weeks	EASI measures the severity and body surface area of eczema on a scale from 0-72.
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.	12 weeks	vIGA-AD measures the severity of eczema on a scale from 0-4.
Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient Oriented Eczema Measurement (POEM) questionnaire.	12 weeks	POEM measures the severity of eczema as experienced by the patient on a scale from 0-28.
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.	12 weeks	PGIS-NRS measures the impression of severity of an individual's skin disorder on a scale from 0-10.
Change in AD phenotype measured by patient-perceived flare ups on a weekly basis for 12 weeks.	12 weeks	Number of days on a weekly basis with flare ups.
Change in AD phenotype measured on a weekly basis for 12 weeks using the Skindex-mini questionnaire.	12 weeks	Skindex-mini measures the symptomatic, emotional and functional aspects of an individual's skin disorder on a scale from 0-18.
Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema-related sleep quality NRS questionnaire.	12 weeks	Eczema-related sleep quality NRS measures the sleep quality, itch and dryness on a scale from 0-10.
Change in AD phenotype measured by the disease extent method on a weekly basis for 12 weeks.	12 weeks	Palm method to measure AD affected body surface area (0-100%).
Change in AD phenotype measured by the Eczema Area and Severity Index (EASI) on a weekly basis for 12 weeks.	12 weeks	EASI measures the severity and body surface area of eczema on a scale from 0-72.

Secondary Outcome Measures

Name	Time	Method
Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials	12 weeks	Number of completers receiving DNA lifestyle reports/information reports at different time points will be compared to evaluate effect on retention.

Trial Locations

Locations (2)

450 Broadway F4; 🇺🇸 Redwood City, California, United States

Studies&Me; 🇩🇰 Copenhagen, Denmark