Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Northwestern University
Sponsor:
Collaborator:
Rockefeller University
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT01782703
First received: January 31, 2013
Last updated: December 25, 2015
Last verified: December 2015
  Purpose

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.


Condition
Atopic Dermatitis
Eczema

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Cellular infiltrates [ Time Frame: One year ] [ Designated as safety issue: No ]
    We will examine your skin and blood samples for various immune cells known to be involved in atopic dermatitis.

  • Gene expression [ Time Frame: One Year ] [ Designated as safety issue: No ]
    We will examine your skin and blood samples for various genes known to contribute to atopic dermatitis by analyzing RNA and cytokines.


Secondary Outcome Measures:
  • Correlation of biomarkers to quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
    We will analyze the blood and tissue biomarkers to determine whether they are comparable to quality of life and itch (pruritus) measures.


Biospecimen Retention:   Samples With DNA
We have retained whole blood and tissue samples (skin and cheek swabs)

Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited at Ann and Robert H. Lurie Children's Hospital of Chicago Division of Dermatology outpatient clinics.

  • 100 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 will be enrolled to obtain blood samples.
  • AD subjects between the ages of 0 months to 4 years of age will be asked to give buccal (cheek) swabs to test for a mutation in filaggrin, a common skin protein.
  • 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, who may or may not have participated in the aforementioned assessments, for imaging evaluation.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782703

Contacts
Contact: Thy Huynh, MD 312-227-6486 thy.huynh@northwestern.edu

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Thy Huynh, MD    312-227-6486    thy.huynh@northwestern.edu   
Principal Investigator: Amy Paller, MD         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Amy Paller, MD    312-227-6060    apaller@northwestern.edu   
Principal Investigator: Amy Paller, MD         
Northbrook Lurie Children's Outpatient Clinic Recruiting
Northbrook, Illinois, United States, 60062
Contact: Amy Paller    312-227-7600    apaller@northwestern.edu   
United States, New York
Rockefeller University Recruiting
New York, New York, United States, 10065
Contact: Emma Guttman, MD, PhD    212-327-8232    eguttman@mail.rockefeller.edu   
Principal Investigator: Emma Guttman, MD, PhD         
Sponsors and Collaborators
Northwestern University
Rockefeller University
Investigators
Principal Investigator: Amy Paller, MD Northwestern University
Principal Investigator: Emma Guttman, MD The Rockefeller University
  More Information

Additional Information:
Publications:
Responsible Party: Amy Paller, Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01782703     History of Changes
Other Study ID Numbers: 2013-15143 
Study First Received: January 31, 2013
Last Updated: December 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Atopic Dermatitis
Filaggrin
Biomarkers
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on February 07, 2016