NCT02926807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

October 5, 2016

Last Update Submit

December 17, 2018

Conditions

Atopic DermatitisVascular InflammationCoronary Atherosclerosis

Keywords

Atopic DermatitisVascular InflammationCoronary AtherosclerosisAscending aortaPet scan

Outcome Measures

Primary Outcomes (1)

  • Target to background ratio (TBR) from the ascending aorta

    0 Days

Secondary Outcomes (2)

  • Target to background ratio (TBR) from the carotids

    0 Days

  • Agatston score

    0 Days

Other Outcomes (1)

  • Correlation between target to background ratio (TBR) and biomarkers, AD severity measurements (EASI, BSA, IGA and SCORAD), endothelial cell-derived micro particles.

    0 Days

Study Arms (2)

Atopic Dermatis Subjects

30 subjects with atopic dermatitis

Other: FDG-PET ScanOther: MDCTOther: biopsy and blood collection

Healthy Volunteers

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 ScanOther: MDCTOther: biopsy and blood collection

Interventions

FDG-PET ScanOTHER

a 18FDG-PET to quantify vascular inflammation

Atopic Dermatis SubjectsHealthy Volunteers
MDCTOTHER

a MDCT to calculate the Agatston score

Atopic Dermatis SubjectsHealthy Volunteers
biopsy and blood collectionOTHER

biopsy and blood collection to assess biomarkers

Atopic Dermatis SubjectsHealthy Volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 30 subjects with atopic dermatitis and 30 subjects without AD will be included in this study.

You may qualify if:

  • Men or women
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovaderm Research Inc

Montreal, Quebec, H3K 4L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, AtopicCoronary Artery Disease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Innovaderm Research clinical site

    Innovaderm Research clinical site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 6, 2016

Study Start

January 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)