Clinical trial NCT04965233: Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
Official title: Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atopic Dermatitis
Eczema
DNA
Lead sponsor: Studies&Me
Sponsor class: INDUSTRY
Collaborators: name: Bispebjerg Hospital
name: Biotx.ai
name: Life&Brain
name: Stanford Health Care
First posted: 2021-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient Oriented Eczema Measurement (POEM) questionnaire.
timeFrame: 12 weeks
measure: Change in AD phenotype measured on a weekly basis for 12 weeks using the Skindex-mini questionnaire.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema-related sleep quality NRS questionnaire.
timeFrame: 12 weeks
measure: Change in AD phenotype measured by patient-perceived flare ups on a weekly basis for 12 weeks.
timeFrame: 12 weeks
measure: Change in AD phenotype measured by the disease extent method on a weekly basis for 12 weeks.
timeFrame: 12 weeks
measure: Change in AD phenotype measured by the Eczema Area and Severity Index (EASI) on a weekly basis for 12 weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
timeFrame: 12 weeks
Other outcomes:
measure: Correlation between environmental factors and AD flare ups
timeFrame: 12 weeks
measure: Number of days on a weekly cycle of patient-use of medication/treatment
timeFrame: 12 weeks
Locations:
city: Redwood City
country: United States
facility: 450 Broadway F4
state: California
city: Copenhagen
country: Denmark
facility: Studies&Me
Study officials:
affiliation: Study Principal Investigator
name: Justin M Ko, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: