Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

NCT01782703 | Active Not Recruiting

• 1 other identifier: 2013-15143
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Atopic Dermatitis; Eczema

Keywords

Atopic Dermatitis; Filaggrin; Biomarkers; Eczema

Outcome Measures

Primary Outcomes (2)

• Cellular infiltrates

  We will examine skin and blood samples for various immune cells known to be involved in atopic dermatitis.

  One year

• Gene expression

  We will examine skin and blood samples for various genes known to contribute to atopic dermatitis by analyzing RNA and cytokines.

  One Year

Secondary Outcomes (1)

• Correlation of biomarkers to quality of life

  One year

Other Outcomes (1)

• Development of a panel of non-invasive biomarkers from tape strip samples

  Two years

Study Arms (3)

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

Eligibility Criteria

• Age: 0 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

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)

Sponsors & Collaborators

• Northwestern University: lead
• Rockefeller University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (4)

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

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northbrook Lurie Children's Outpatient Clinic

Northbrook, Illinois, 60062, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10065, United States

Location

Related Publications (3)

• Bieber T. Atopic dermatitis. Ann Dermatol. 2010 May;22(2):125-37. doi: 10.5021/ad.2010.22.2.125. Epub 2010 May 17.

  PMID: 20548901 BACKGROUND

• Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part II: immune cell subsets and therapeutic concepts. J Allergy Clin Immunol. 2011 Jun;127(6):1420-32. doi: 10.1016/j.jaci.2011.01.054. Epub 2011 Mar 21.

  PMID: 21419481 BACKGROUND

• Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part I: clinical and pathologic concepts. J Allergy Clin Immunol. 2011 May;127(5):1110-8. doi: 10.1016/j.jaci.2011.01.053. Epub 2011 Mar 8.

  PMID: 21388665 BACKGROUND

Related Links

• Eczema: MedlinePlus

Biospecimen

Retention: SAMPLES WITH DNA

We have retained whole blood and tissue samples (skin and cheek swabs)

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Amy Paller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Emma Guttman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Dermatology, Professor of Pediatrics

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: January 1, 2013
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (4)