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Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01782703
Recruitment Status : Recruiting
First Posted : February 4, 2013
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Rockefeller University
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Amy Paller, Northwestern University

January 31, 2013
February 4, 2013
October 11, 2018
January 2013
December 2019   (Final data collection date for primary outcome measure)
  • Cellular infiltrates [ Time Frame: One year ]
    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 ]
    We will examine your skin and blood samples for various genes known to contribute to atopic dermatitis by analyzing RNA and cytokines.
Same as current
Complete list of historical versions of study NCT01782703 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis
Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

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.

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.
Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
We have retained whole blood and tissue samples (skin and cheek swabs)
Non-Probability Sample

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.
  • Atopic Dermatitis
  • Eczema
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
100
December 2019
December 2019   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
up to 17 Years   (Child)
Yes
Contact: DermatologyCTU 312-503-5944 NUderm-research@northwestern.edu
United States
 
 
NCT01782703
2013-15143
No
Not Provided
Not Provided
Amy Paller, Northwestern University
Northwestern University
  • Rockefeller University
  • Icahn School of Medicine at Mount Sinai
Principal Investigator: Amy Paller, MD Northwestern University
Principal Investigator: Emma Guttman, MD Icahn School of Medicine at Mount Sinai
Northwestern University
October 2018