Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

April 22, 2026 updated by: Amy Paller, Northwestern University

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.)

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Northbrook, Illinois, United States, 60062
        • Northbrook Lurie Children's Outpatient Clinic
    • New York
      • New York, New York, United States, 10065
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Healthy subjects with no history of atopy (atopic dermatitis, asthma, or allergic rhinitis) from 0 months to 17 years of age that are age and sex matched to our atopic dermatitis subjects.
Atopic Dermatitis
Children with atopic dermatitis from 0 months to 17 years of age.
Control with Atopy history
Healthy subjects from 0 months to 17 years of age with history of asthma, food allergies, or allergic rhinitis, but no atopic dermatitis or with positive family history of atopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular infiltrates
Time Frame: One year
We will examine skin and blood samples for various immune cells known to be involved in atopic dermatitis.
One year
Gene expression
Time Frame: One Year
We will examine skin and blood samples for various genes known to contribute to atopic dermatitis by analyzing RNA and cytokines.
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of biomarkers to quality of life
Time Frame: One year
We will analyze the blood and tissue biomarkers to determine whether they are comparable to quality of life and itch (pruritus) measures.
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of a panel of non-invasive biomarkers from tape strip samples
Time Frame: Two years
Development of a panel of non-invasive biomarkers from tape strip samples
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Icahn School of Medicine at Mount Sinai
Rockefeller University

Investigators

  • Principal Investigator: Emma Guttman, MD, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Amy Paller, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimated)

February 4, 2013

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-15143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eczema

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe