Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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.)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01782703
• Other study ID #: 2013-15143
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: DermatologyCTU
• Phone: 312-503-5944
• Email: NUderm-research[@]northwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 930
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Icahn School of Medicine at Mount Sinai, Rockefeller University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Development of a panel of non-invasive biomarkers from tape strip samples	Development of a panel of non-invasive biomarkers from tape strip samples	Two years
Primary	Cellular infiltrates	We will examine skin and blood samples for various immune cells known to be involved in atopic dermatitis.	One year
Primary	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	Correlation of biomarkers to quality of life	We will analyze the blood and tissue biomarkers to determine whether they are comparable to quality of life and itch (pruritus) measures.	One year

External Links

•   Eczema: MedlinePlus