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Completed

NCT Number: NCT02926807

Trial on Vascular Inflammation in 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FDG-PET scan

Other

a 18FDG-PET to quantify vascular inflammation

MDCT

Other

a MDCT to calculate the Agatston score

biopsy and blood collection

Other

biopsy and blood collection to assess biomarkers

Primary outcomes

  1. Target to background ratio (TBR) from the ascending aorta

    Time frame: 0 Days

Secondary outcomes

  1. Target to background ratio (TBR) from the carotids

    Time frame: 0 Days

  2. Agatston score

    Time frame: 0 Days

Other outcomes

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

    Time frame: 0 Days

Sponsors and collaborators

Lead sponsor

Innovaderm Research Inc.

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • Montreal Heart Institute

Registry information

Official study title

Vascular Inflammation and Coronary Atherosclerosis Risks in Subjects With Atopic Dermatitis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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