Trial on Vascular Inflammation in Atopic Dermatitis

Innovaderm Research

Status: Completed

Conditions: Atopic Dermatitis; Coronary Atherosclerosis; Vascular Inflammation

Treatments: Other: biopsy and blood collection; Other: MDCT; Other: FDG-PET Scan

Study type: Observational

Funder types: Other

Identifiers

NCT02926807

Inno-6043

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

57 participants in 2 patient groups

Atopic Dermatis Subjects

Description:

30 subjects with atopic dermatitis

Treatment:

Other: biopsy and blood collection

Other: FDG-PET Scan

Other: MDCT

Healthy Volunteers

Description:

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

Treatment:

Other: biopsy and blood collection

Other: FDG-PET Scan

Other: MDCT