Atopic DermatitisNCT04965233
Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
An observational study of Atopic Dermatitis and Eczema, run by Studies&Me at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema, DNA
- What is being tested?
- DNA reports and Information reports
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Nov 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Conditions
- Atopic Dermatitis, Eczema, DNA
- Being tested
- DNA reports, Information reports
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA reportsBehavioural
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 reportsBehavioural
Reports containing general information on eczema
| Study group | Role | What they receive |
|---|---|---|
| Participants recruited in Denmark | Participants recruited in Denmark will consist of 63 healthy individuals and 187 individuals with atopic dermatitis Receives: Behavioral: Information reports | |
| Participant recruited in the United States of America | Participants recruited in the US will consist of 125 healthy individuals, 3000 individuals with atopic dermatitis Receives: Behavioral: DNA reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
TIS measures the severity of erythema, oedema/papulation and excoriation on a scale from 0-9.
Measured: 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.
EASI measures the severity and body surface area of eczema on a scale from 0-72.
Measured: 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.
vIGA-AD measures the severity of eczema on a scale from 0-4.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 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.
PGIS-NRS measures the impression of severity of an individual's skin disorder on a scale from 0-10.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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%).
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start30 Nov 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Due to protocol changes, and the observational design of this study (not an ACT), the study registry is withdrawn from clinicaltrials.gov.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studies&Me
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bispebjerg Hospital, Biotx.ai, Life&Brain, Stanford Health Care
- Responsible party
- Sponsor
- Investigators
- Justin M Ko, MD, MBA, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965233
- Sponsor's protocol ID
- H-19020696
- Status last verified
- Sep 2021
- First submitted
- 30 Jun 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
- ClinicalTrials.gov ID
- NCT04965233
- Acronym / sponsor ID
- H-19020696
- Conditions
- Atopic Dermatitis, Eczema, DNA
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to protocol changes, and the observational design of this study (not an ACT), the study registry is withdrawn from clinicaltrials.gov.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Studies&MeIndustry (pharma, biotech, devices)
- Collaborators
- Bispebjerg Hospital, Biotx.ai, Life&Brain, Stanford Health Care
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants recruited in Denmark | – | Behavioral: Information reportsParticipants recruited in Denmark will consist of 63 healthy individuals and 187 individuals with atopic dermatitis |
| Participant recruited in the United States of America | – | Behavioral: DNA reportsParticipants recruited in the US will consist of 125 healthy individuals, 3000 individuals with atopic dermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA reportsThe 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. | Behavioural | Participant recruited in the United States of America |
| Information reportsReports containing general information on eczema | Behavioural | Participants recruited in Denmark |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 Skindex-mini questionnaire.
Time frame: 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 Patient's Global Impression of Severity Numerical Rating System (PGIS-NRS) questionnaire.
Time frame: 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 on a weekly basis for 12 weeks using the Eczema-related sleep quality NRS questionnaire.
Time frame: 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 patient-perceived flare ups on a weekly basis for 12 weeks.
Time frame: 12 weeks
Number of days on a weekly basis with flare ups.
Change in AD phenotype measured by the disease extent method on a weekly basis for 12 weeks.
Time frame: 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.
Time frame: 12 weeks
EASI measures the severity and body surface area of eczema on a scale from 0-72.
1 secondary outcome
Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin M Ko, MD, MBA principal investigator
Study Principal Investigator
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Eczema, run by Studies&Me at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.