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Trial on Vascular Inflammation in Atopic Dermatitis

Vascular Inflammation and Coronary Atherosclerosis Risks in Subjects With Atopic Dermatitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02926807
Enrollment
57
Registered
2016-10-06
Start date
2017-01-31
Completion date
2018-11-30
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Coronary Atherosclerosis, Vascular Inflammation

Keywords

Atopic Dermatitis, Vascular Inflammation, Coronary Atherosclerosis, Ascending aorta, Pet scan

Brief 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. 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.

Interventions

OTHERMDCT

a MDCT to calculate the Agatston score

a 18FDG-PET to quantify vascular inflammation

OTHERbiopsy and blood collection

biopsy and blood collection to assess biomarkers

Sponsors

Montreal Heart Institute
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai
CollaboratorOTHER
Innovaderm Research Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Target to background ratio (TBR) from the ascending aorta0 Days

Secondary

MeasureTime frame
Target to background ratio (TBR) from the carotids0 Days
Agatston score0 Days

Other

MeasureTime frame
Correlation between target to background ratio (TBR) and biomarkers, AD severity measurements (EASI, BSA, IGA and SCORAD), endothelial cell-derived micro particles.0 Days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026