Atopic DermatitisNCT02926807
Trial on Vascular Inflammation in Atopic Dermatitis
An observational study of Atopic Dermatitis and Vascular Inflammation, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD matched for sex, age and coronary artery disease risk factor with the AD subjects will also be included. 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, Vascular Inflammation, Coronary Atherosclerosis
- What is being tested?
- FDG-PET Scan, MDCT and biopsy and blood collection
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Nov 2018
- 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: Approximately 30 subjects with atopic dermatitis and 30 subjects without AD will be included in this study.
Main inclusion Criteria:
- Men or women
- 18 years of age or older at time of consent.
- For AD subjects only: Confirmed clinical diagnosis of active AD according to Hanifin and Rajka criteria, BSA, EASI and IGA.
- For AD subjects only: Diagnosis of atopic dermatitis for at least 5 years.
- Women of childbearing potential is willing to use effective contraceptive method.
- Women of childbearing potential must have a negative urine pregnancy test.
Main exclusion Criteria:
- Has known cardiovascular arterial disease, a pacemaker, psoriasis, uncontrolled diabetes.
- Presence of an unstable co-morbidity that could have an effect on vascular inflammation.
- Heart rate restriction for patients with asthma or COPD.
- Use of any topical medication for atopic dermatitis on the site to be biopsied.
- Use of systemic treatments for atopic dermatitis.
- Use of phototherapy, tanning booth or other ultraviolet light sources.
- Use of biologics.
- Use of experimental medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Inflammation and Coronary Atherosclerosis Risks in Subjects With Atopic Dermatitis
A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD matched for sex, age and coronary artery disease risk factor with the AD subjects will also be included. All subjects will undergo the following imaging procedures: a 18FDG-PET to quantify vascular inflammation in the ascending aorta and carotids and a MDCT to calculate the Agatston score. Skin and blood biomarkers will also be assessed.
- Being tested
- FDG-PET Scan, MDCT, biopsy and blood collection
- Keywords
- Atopic Dermatitis, Vascular Inflammation, Coronary Atherosclerosis, Ascending aorta, Pet scan
- Medical subject headings
- Dermatitis, Atopic, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET ScanOther
a 18FDG-PET to quantify vascular inflammation
MDCTOther
a MDCT to calculate the Agatston score
biopsy and blood collectionOther
biopsy and blood collection to assess biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatis Subjects | 30 subjects with atopic dermatitis Receives: Other: FDG-PET Scan; Other: MDCT; Other: biopsy and blood collection | |
| Healthy Volunteers | 30 subjects without AD that matches for sex, age (± 2 years) and coronary artery disease risk factor with the AD subjects will be included as control case Receives: Other: FDG-PET Scan; Other: MDCT; Other: biopsy and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target to background ratio (TBR) from the ascending aorta
Measured: 0 Days
Secondary outcomes (2)
Target to background ratio (TBR) from the carotids
Measured: 0 Days
Agatston score
Measured: 0 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2018
- Study completionNov 2018
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Heart Institute, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Innovaderm Research clinical site, Principal investigator, Innovaderm Research clinical site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926807
- Sponsor's protocol ID
- Inno-6043
- Status last verified
- Dec 2018
- First submitted
- 5 Oct 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Inflammation and Coronary Atherosclerosis Risks in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02926807
- Acronym / sponsor ID
- Inno-6043
- Keywords
- Atopic Dermatitis, Vascular Inflammation, Coronary Atherosclerosis, Ascending aorta, Pet scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Montreal Heart Institute, Icahn School of Medicine at Mount Sinai
- Study start
- Jan 2017
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD matched for sex, age and coronary artery disease risk factor with the AD subjects will also be included. All subjects will undergo the following imaging procedures: a 18FDG-PET to quantify vascular inflammation in the ascending aorta and carotids and a MDCT to calculate the Agatston score. Skin and blood biomarkers will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatis Subjects | – | Other: FDG-PET Scan, Other: MDCT, Other: biopsy and blood collection30 subjects with atopic dermatitis |
| Healthy Volunteers | – | Other: FDG-PET Scan, Other: MDCT, Other: biopsy and blood collection30 subjects without AD that matches for sex, age (± 2 years) and coronary artery disease risk factor with the AD subjects will be included as control case |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 30 subjects with atopic dermatitis and 30 subjects without AD will be included in this study.
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 |
|---|---|---|
| FDG-PET Scana 18FDG-PET to quantify vascular inflammation | Other | Atopic Dermatis Subjects, Healthy Volunteers |
| MDCTa MDCT to calculate the Agatston score | Other | Atopic Dermatis Subjects, Healthy Volunteers |
| biopsy and blood collectionbiopsy and blood collection to assess biomarkers | Other | Atopic Dermatis Subjects, Healthy Volunteers |
Primary outcome
Target to background ratio (TBR) from the ascending aorta
Time frame: 0 Days
2 secondary outcomes
Target to background ratio (TBR) from the carotids
Time frame: 0 Days
Agatston score
Time frame: 0 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- 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.
Innovaderm Research clinical site principal investigator
Innovaderm Research clinical site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Vascular Inflammation, run by Innovaderm Research Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Target to background ratio (TBR) from the ascending aorta (time frame: 0 Days). 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 19 Dec 2018.