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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02926807
Other study ID # Inno-6043
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date November 2018

Study information

Verified date December 2018
Source Innovaderm Research Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date November 2018
Est. primary completion date November 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
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

Locations

Country Name City State
Canada Innovaderm Research Inc Montreal Quebec

Sponsors (3)

Lead Sponsor Collaborator
Innovaderm Research Inc. Icahn School of Medicine at Mount Sinai, Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Correlation between target to background ratio (TBR) and biomarkers, AD severity measurements (EASI, BSA, IGA and SCORAD), endothelial cell-derived micro particles. 0 Days
Primary Target to background ratio (TBR) from the ascending aorta 0 Days
Secondary Target to background ratio (TBR) from the carotids 0 Days
Secondary Agatston score 0 Days
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