Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

Plain-language summary

This study aims to identify skin and blood biomarkers associated with atopic dermatitis (eczema) in children. It enrolled children aged 0-17 with atopic dermatitis, along with healthy and atopic control groups. It is being carried out as a study without an assigned phase; it is not currently recruiting but is still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Northwestern University

Start date

1/1/2013

Estimated completion

12/1/2027

Countries

United States

Related genes

Locations

• Chicago, United States
• Chicago, United States
• Northbrook, United States
• New York, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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)