Trial on Vascular Inflammation in Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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Vascular Inflammation and Coronary Atherosclerosis Risks in Subjects With Atopic Dermatitis

Conditions
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Atopic Dermatitis, Vascular Inflammation, Coronary Atherosclerosis

Intervention / Treatment
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* Other: FDG-PET Scan
* Other: MDCT
* Other: biopsy and blood collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atopic Dermatis Subjects<br>30 subjects with atopic dermatitis | Other: FDG-PET Scan<br>* a 18FDG-PET to quantify vascular inflammation<br>Other: MDCT<br>* a MDCT to calculate the Agatston score<br>Other: biopsy and blood collection<br>* biopsy and blood collection to assess biomarkers<br>|
| Healthy Volunteers<br>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<br>* a 18FDG-PET to quantify vascular inflammation<br>Other: MDCT<br>* a MDCT to calculate the Agatston score<br>Other: biopsy and blood collection<br>* biopsy and blood collection to assess biomarkers<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Vascular Inflammation, Coronary Atherosclerosis, Ascending aorta, Pet scan