Trial on Vascular Inflammation in Atopic Dermatitis

Completed

• Conditions: Atopic Dermatitis; Coronary Atherosclerosis; Vascular Inflammation
• Interventions: Other: FDG-PET Scan; Other: MDCT; Other: biopsy and blood collection

• Registration Number: NCT02926807
• Lead Sponsor: Innovaderm Research Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Study Start: 2017-01
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atopic Dermatis Subjects	FDG-PET Scan	30 subjects with atopic dermatitis
Atopic Dermatis Subjects	biopsy and blood collection	30 subjects with atopic dermatitis
Healthy Volunteers	biopsy and blood collection	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
Atopic Dermatis Subjects	MDCT	30 subjects with atopic dermatitis
Healthy Volunteers	FDG-PET Scan	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
Healthy Volunteers	MDCT	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

Primary Outcome Measures

Name	Time	Method
Target to background ratio (TBR) from the ascending aorta	0 Days

Secondary Outcome Measures

Name	Time	Method
Target to background ratio (TBR) from the carotids	0 Days
Agatston score	0 Days

Trial Locations

Locations (1)

Innovaderm Research Inc; 🇨🇦 Montreal, Quebec, Canada