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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04965233
• Other study ID #: H-19020696
• Status: Withdrawn
• Start date: November 30, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Studies&Me
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• DNA
• Eczema

Intervention

Behavioral:
• 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.
• Information reports
Reports containing general information on eczema

Locations

Country	Name	City	State
Denmark	Studies&Me	Copenhagen
United States	450 Broadway F4	Redwood City	California

Sponsors (5)

Lead Sponsor	Collaborator
Studies&Me	Biotx.ai, Bispebjerg Hospital, Life&Brain, Stanford Health Care

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between environmental factors and AD flare ups	Passive data on geographical localisation, daily activity level and an approximation for length of sleep	12 weeks
Other	Number of days on a weekly cycle of patient-use of medication/treatment	Number of days on a weekly cycle of patient-use of medication/treatment	12 weeks
Primary	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.	SCORAD measures the severity of eczema on a scale from 0-103.	12 weeks
Primary	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.	TIS measures the severity of erythema, oedema/papulation and excoriation on a scale from 0-9.	12 weeks
Primary	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.	EASI measures the severity and body surface area of eczema on a scale from 0-72.	12 weeks
Primary	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.	vIGA-AD measures the severity of eczema on a scale from 0-4.	12 weeks
Primary	Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient Oriented Eczema Measurement (POEM) questionnaire.	POEM measures the severity of eczema as experienced by the patient on a scale from 0-28.	12 weeks
Primary	Change in AD phenotype measured on a weekly basis for 12 weeks using the Skindex-mini questionnaire.	Skindex-mini measures the symptomatic, emotional and functional aspects of an individual's skin disorder on a scale from 0-18.	12 weeks
Primary	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.	PGIS-NRS measures the impression of severity of an individual's skin disorder on a scale from 0-10.	12 weeks
Primary	Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema-related sleep quality NRS questionnaire.	Eczema-related sleep quality NRS measures the sleep quality, itch and dryness on a scale from 0-10.	12 weeks
Primary	Change in AD phenotype measured by patient-perceived flare ups on a weekly basis for 12 weeks.	Number of days on a weekly basis with flare ups.	12 weeks
Primary	Change in AD phenotype measured by the disease extent method on a weekly basis for 12 weeks.	Palm method to measure AD affected body surface area (0-100%).	12 weeks
Primary	Change in AD phenotype measured by the Eczema Area and Severity Index (EASI) on a weekly basis for 12 weeks.	EASI measures the severity and body surface area of eczema on a scale from 0-72.	12 weeks
Secondary	Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials	Number of completers receiving DNA lifestyle reports/information reports at different time points will be compared to evaluate effect on retention.	12 weeks