Trial on Vascular Inflammation in Atopic Dermatitis

December 17, 2018 updated by: Innovaderm Research Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3K 4L5
        • Innovaderm Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 30 subjects with atopic dermatitis and 30 subjects without AD will be included in this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atopic Dermatis Subjects
30 subjects with atopic dermatitis
Other: FDG-PET Scan
a 18FDG-PET to quantify vascular inflammation
Other: MDCT
a MDCT to calculate the Agatston score
Other: 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
Other: FDG-PET Scan
a 18FDG-PET to quantify vascular inflammation
Other: MDCT
a MDCT to calculate the Agatston score
Other: biopsy and blood collection
biopsy and blood collection to assess biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target to background ratio (TBR) from the ascending aorta
Time Frame: 0 Days
0 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Target to background ratio (TBR) from the carotids
Time Frame: 0 Days
0 Days
Agatston score
Time Frame: 0 Days
0 Days

Other Outcome Measures

Outcome Measure
Time Frame
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
0 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovaderm Research Inc.

Collaborators

Icahn School of Medicine at Mount Sinai
Montreal Heart Institute

Investigators

  • Principal Investigator: Innovaderm Research clinical site, Innovaderm Research clinical site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (ESTIMATE)

October 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inno-6043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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