Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

Last updated: March 11, 2024
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atopic Dermatitis

Allergies & Asthma

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT01782703
2013-15143
  • Ages < 17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Subjects may be of either sex and must be between the ages of 0 months and 17 years atthe time of enrollment (Healthy controls, atopic controls, and AD patients)
  • The skin sample and blood sample for healthy controls can have no systemicinflammatory 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 orasthma) but no history of atopic dermatitis
  • All controls for skin sampling may have no observable abnormality in the sampled skinand, to further assure the normality of the "normal" skin edges, must not haveevidence 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 diseasewithin the last 6 months or with acute exacerbation of AD
  • Subjects 17 years of age and older and parents/guardians of minors must sign theapproved IRB assent and consent form(s) respectively prior to initiation of the studyprotocol

Exclusion

Exclusion Criteria:

  • Subjects unable to give assent or parents unable to give consent due to cognitivedelay or inability to understand the assent form either in writing or presentedverbally (Healthy controls, atopic controls, and AD patients)
  • All subjects whose main diagnosis is deemed unsafe by the study investigator for studyparticipation. Examples include known hemophilia or other blood disorders, or skininfection at the site of blood draw or biopsy (Healthy controls, atopic controls, andAD patients)
  • Control subjects with obvious xerosis (Healthy controls and atopic controls)

Study Design

Total Participants: 930
Study Start date:
January 01, 2013
Estimated Completion Date:
December 31, 2025

Study Description

Objectives:

  1. To define the cellular and molecular biomarkers of atopic dermatitis in skin biopsies and blood samples from a pre-adolescent pediatric population and correlate it with disease severity.

  2. To measure the skin barrier in atopic dermatitis.

  3. To determine quality of life in atopic dermatitis through various questionnaires.

Objectives for the non-invasive biomarkers sub-study:

  1. Develop a panel of non-invasive biomarkers in tape strips and serum.

  2. Correlate mRNA expression from tape-striped skin with individual markers of severity (EASI, SCORAD, pruritus and TEWL).

  3. Correlate mRNA markers in blood with severity scores.

  4. Correlate serum protein markers with severity scores.

  5. Compare biomarkers based on patient age.

  6. Correlate the biomarker candidates from tape strips and blood with the "gold standard" set of biomarkers derived from age-matched skin biopsy samples

Connect with a study center

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Glenbrook Hospital

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Northbrook Lurie Children's Outpatient Clinic

    Northbrook, Illinois 60062
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10065
    United States

    Active - Recruiting

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