Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

Status:	Recruiting
Conditions:	Psoriasis, Skin and Soft Tissue Infections, Dermatology
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	Any - 17
Updated:	10/13/2018
Start Date:	January 2013
End Date:	December 2019
Contact:	DermatologyCTU
Email:	NUderm-research@northwestern.edu
Phone:	312-503-5944

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.

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)

We found this trial at

sites

Northwestern University

303 East Superior Street
Chicago, Illinois 60611

Principal Investigator: Amy Paller, MD

Phone: 312-695-3721

from

Chicago, IL