Trial record 10 of 47 for:    Open Studies | "Eczema"

Defining the Unique Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 20, 2014
Last verified: February 2014
  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 Unique 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: 100
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (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 3 months to 12 years of age that are age and sex matched to our atopic dermatitis subjects.
Atopic Dermatitis
Children with atopic dermatitis from 3 months to 12 years of age.

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:   3 Months to 12 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.

Subjects will be between the ages of 3 months to 12 years old. Both male and female subjects will be recruited.

A total of 30 subjects with moderate to severe AD, and 30 age-matched and sex-matched healthy (no evidence of atopy: atopic dermatitis, asthma, or allergic rhinitis) controls will be enrolled to obtain blood samples.

20 children with moderate to severe AD and 20 age-and sex-matched healthy (no evidence of atopy: atopic dermatitis, asthma, or allergic rhinitis) controls will be enrolled to obtain skin biopsies.

Criteria

Inclusion Criteria:

  • Subjects may be of either sex and must be between the ages of 3 months and 12 years at the time of enrollment (controls and AD patients)
  • Controls may have no inflammatory disease or atopy (urticaria, food allergy, allergic rhinitis or conjunctivitis, asthma)
  • 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
  • Subjects have moderate to severe atopic dermatitis, (assessed by Scoring Atopic Dermatitis (SCORAD) clinical tool with a score of greater than 25), with either new onset disease within the last 6 months or with an acute exacerbation of AD
  • Subjects should not have administered systemic immunosuppressant therapy in the month before the study
  • Subjects should not use more potent topical steroids in the week before the study, but may use class IV-VII topical steroids or calcineurin inhibitors in the week prior to blood and biopsy sampling
  • Subjects should not have applied topical immunomodulators (steroid or calcineurin inhibitors) to the planned biopsy sites and the surrounding 4-5 cm of skin within 1 week of the biopsy
  • Subject should not have applied emollients to the planned biopsy sites within 12 hours before biopsy, but can have been applied elsewhere
  • Subjects and guardians of minors must sign Institutional Review Board (IRB)-approved consent form(s) prior to initiation of the study protocol

Exclusion Criteria:

  • Subjects who are unable to give informed consent or assent
  • Subjects who have mild atopic dermatitis (assessed by SCORAD questionnaire by study personnel and with a score of less than 25)
  • Subjects who administered anti-inflammatory systemic and topical therapy or emollients that do not comply with inclusion criteria prior to blood and biopsy sampling
  • Subjects whose main diagnosis is deemed unsafe by the study investigator for study participation
  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: Gil Abramovici, MD 312-227-6484 gabramovici@luriechildrens.org
Contact: Lori Asztalos 312-227-6486 MAsztalos@luriechildrens.org

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Gil Abramovici, MD    312-227-6484    gabramovici@luriechildrens.org   
Principal Investigator: Amy Paller, MD         
Sub-Investigator: Gil Abramovici, MD         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Amy Paller, MD    312-227-6060    apaller@northwestern.edu   
Principal Investigator: Amy Paller, MD         
Sub-Investigator: Gil Abramovici, MD         
Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60026
Contact: Amy Paller, MD    312-227-6060    apaller@northwestern.edu   
Principal Investigator: Amy Paller, MD         
Sub-Investigator: Gil Abramovici, MD         
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: February 20, 2014
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
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014