Logo of National Eczema Association mobile menu icon
Icon link to National Eczema's Instagram feed. Icon link to National Eczema's YouTube channel. Icon link to National Eczema's Facebook page. Icon link to National Eczema's Twitter feed. Icon link to National Eczema's inspire.com page. Search Icon to search the site

Get the tools and support you need to best manage your eczema

  • This field is for validation purposes and should be left unchanged.

Clinical Trial Details for Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis


Northwestern University
NCT ID: NCT01782703
Last Updated: January 7, 2020

The Study at a Glance

  • Status: Recruiting
  • Phase:
  • Gender: All
  • Age: N/A - 17 Years
  • Condition:
    • Atopic Dermatitis
    • Eczema
  • Study Type: Observational
  • Intervention:
  • Lead Sponsor: Northwestern University
  • Location: Not Provided

Official Title

Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis SUB-STUDY: Defining the Predictive Non-Invasive Biomarkers for Pediatric Atopic Dermatitis (Funded by Regeneron Pharmaceuticals, Inc.)

Purpose

Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder of children, affecting 10-20% of children and 1-2% of adults. This skin disorder can be associated with unbearable itchiness and an increased susceptibility to skin infections. The cause of AD is currently poorly understood; therefore, there are no targeted treatment options at present. There have been recent studies in adults with AD that explain the cause and give us new routes to investigate treatment options, however no major studies in this arena have been done in children. We hope to evaluate the skin and blood biomarkers that are found in pediatric AD and compare them to adult AD. Hypothesis: The immune system worsens the skin barrier issues that are common in atopic dermatitis. We believe there are similar immune and skin abnormalities in adult versus pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic dermatitis can serve as surrogates for skin immune activation and will correlate with disease severity.

Eligibility

Ages Eligible for Study

N/A to 17 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Population

Subjects will be recruited at Ann and Robert H. Lurie Children’s Hospital Dermatology
outpatient clinics.

– 200 children with mild to severe AD, 100 aged-matched and sex-matched healthy (no
evidence of atopy) controls, 100 aged-matched and sex-matched controls with an atopic
condition (allergic rhinitis or asthma) but no history of atopic dermatitis

– AD subjects between the ages of 0 months to 4 years of age will be asked to give
buccal (cheek) swabs

– 70 children with mild to severe atopic dermatitis, and 70 age- and sex-matched (but
not site-matched) healthy controls (no evidence of atopy), will be enrolled to obtain
skin biopsies.

– 30 children with atopic dermatitis and 30 age/sex matched non-atopic controls for
imaging evaluation.

– Transepidermal water loss values will obtained in 300 healthy controls.

– Cord blood will be collected from 30 healthy subjects at the time of delivery.

Criteria

Inclusion Criteria:

– Subjects may be of either sex and must be between the ages of 0 months and 17 years at
the time of enrollment (Healthy controls, atopic controls, and AD patients)

– The skin sample and blood sample for healthy controls can have no systemic
inflammatory disease or personal or familial history of atopy (hives, food allergy,
allergic rhinitis or conjunctivitis, asthma)

– The atopic blood sample controls may have an atopic condition (allergic rhinitis or
asthma) but no history of atopic dermatitis

– All controls for skin sampling may have no observable abnormality in the sampled skin
and, to further assure the normality of the "normal" skin edges, must not have
evidence of inflammation or epidermal change in the lesion to be surgically removed

– AD subjects must have mild to severe atopic dermatitis with either new onset disease
within the last 6 months or with acute exacerbation of AD

– Subjects 17 years of age and older and parents/guardians of minors must sign the
approved IRB assent and consent form(s) respectively prior to initiation of the study
protocol

Exclusion Criteria:

– Subjects unable to give assent or parents unable to give consent due to cognitive
delay or inability to understand the assent form either in writing or presented
verbally (Healthy controls, atopic controls, and AD patients)

– All subjects whose main diagnosis is deemed unsafe by the study investigator for study
participation. Examples include known hemophilia or other blood disorders, or skin
infection at the site of blood draw or biopsy (Healthy controls, atopic controls, and
AD patients)

– Control subjects with obvious xerosis (Healthy controls and atopic controls)

Additional Information, Locations & Contacts

Sponsors & Collaborators

Northwestern University

Rockefeller University

Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Amy Paller, MD

Northwestern University

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782703

Location

Contacts

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Northwestern University

Chicago, Illinois 60611

United States

Northbrook Lurie Children's Outpatient Clinic

Northbrook, Illinois 60062

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10065

United States

Emma Guttman, MD, PhD

emma.guttman@mountsinai.org