Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

Running, not enrolling

Conditions studied: Atopic Dermatitis, Eczema

In brief

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.

Key facts

Study ID

NCT01782703

Run by

Northwestern University

People needed

505

Starts

2013-01-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-27

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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