Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
57 participants
OBSERVATIONAL
2017-01-31
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Atopic Dermatis Subjects
30 subjects with atopic dermatitis
FDG-PET Scan
a 18FDG-PET to quantify vascular inflammation
MDCT
a MDCT to calculate the Agatston score
biopsy and blood collection
biopsy and blood collection to assess biomarkers
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
FDG-PET Scan
a 18FDG-PET to quantify vascular inflammation
MDCT
a MDCT to calculate the Agatston score
biopsy and blood collection
biopsy and blood collection to assess biomarkers
Interventions
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FDG-PET Scan
a 18FDG-PET to quantify vascular inflammation
MDCT
a MDCT to calculate the Agatston score
biopsy and blood collection
biopsy and blood collection to assess biomarkers
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Montreal Heart Institute
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Innovaderm Research Inc.
OTHER
Responsible Party
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Principal Investigators
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Innovaderm Research clinical site
Role: PRINCIPAL_INVESTIGATOR
Innovaderm Research clinical site
Locations
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Innovaderm Research Inc
Montreal, Quebec, Canada
Countries
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Other Identifiers
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Inno-6043
Identifier Type: -
Identifier Source: org_study_id