Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
2021년 9월 13일 업데이트: 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.
연구 개요
연구 유형
관찰
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Participants recruited in Denmark
Participants recruited in Denmark will consist of 63 healthy individuals and 187 individuals with atopic dermatitis
|
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
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: 12 weeks
|
SCORAD measures the severity of eczema on a scale from 0-103.
|
12 weeks
|
|
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.
기간: 12 weeks
|
TIS measures the severity of erythema, oedema/papulation and excoriation on a scale from 0-9.
|
12 weeks
|
|
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.
기간: 12 weeks
|
EASI measures the severity and body surface area of eczema on a scale from 0-72.
|
12 weeks
|
|
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.
기간: 12 weeks
|
vIGA-AD measures the severity of eczema on a scale from 0-4.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient Oriented Eczema Measurement (POEM) questionnaire.
기간: 12 weeks
|
POEM measures the severity of eczema as experienced by the patient on a scale from 0-28.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Skindex-mini questionnaire.
기간: 12 weeks
|
Skindex-mini measures the symptomatic, emotional and functional aspects of an individual's skin disorder on a scale from 0-18.
|
12 weeks
|
|
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.
기간: 12 weeks
|
PGIS-NRS measures the impression of severity of an individual's skin disorder on a scale from 0-10.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema-related sleep quality NRS questionnaire.
기간: 12 weeks
|
Eczema-related sleep quality NRS measures the sleep quality, itch and dryness on a scale from 0-10.
|
12 weeks
|
|
Change in AD phenotype measured by patient-perceived flare ups on a weekly basis for 12 weeks.
기간: 12 weeks
|
Number of days on a weekly basis with flare ups.
|
12 weeks
|
|
Change in AD phenotype measured by the disease extent method on a weekly basis for 12 weeks.
기간: 12 weeks
|
Palm method to measure AD affected body surface area (0-100%).
|
12 weeks
|
|
Change in AD phenotype measured by the Eczema Area and Severity Index (EASI) on a weekly basis for 12 weeks.
기간: 12 weeks
|
EASI measures the severity and body surface area of eczema on a scale from 0-72.
|
12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
기간: 12 weeks
|
Number of completers receiving DNA lifestyle reports/information reports at different time points will be compared to evaluate effect on retention.
|
12 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation between environmental factors and AD flare ups
기간: 12 weeks
|
Passive data on geographical localisation, daily activity level and an approximation for length of sleep
|
12 weeks
|
|
Number of days on a weekly cycle of patient-use of medication/treatment
기간: 12 weeks
|
Number of days on a weekly cycle of patient-use of medication/treatment
|
12 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Justin M Ko, MD, MBA, Study Principal Investigator
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 11월 30일
기본 완료 (예상)
2021년 12월 31일
연구 완료 (예상)
2021년 12월 31일
연구 등록 날짜
최초 제출
2021년 6월 30일
QC 기준을 충족하는 최초 제출
2021년 7월 15일
처음 게시됨 (실제)
2021년 7월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 13일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .