Trial on Vascular Inflammation in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Vascular Inflammation and Coronary Atherosclerosis Risks in Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926807
• Other study ID #: Inno-6043
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atopic Dermatitis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Inflammation
• Myocardial Ischemia
• Vascular Inflammation

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