Registry for the Atopic Dermatitis Research Network

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01494142
First received: October 31, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

People with atopic dermatitis (AD), also known as eczema, experience hot, dry, scaly skin with severe itching. In addition, people with AD are prone to skin infections and inflammation. Little is known about the causes of AD or why people with AD are more prone to infections. The purpose of this multi-center, clinical registry study is to determine genetic markers associated with susceptibility of AD patients to infections and to also serve as a potential participant database for future studies.

Study procedures will usually be completed in one visit to the clinic; however, participants may need to return for one or more additional visits to provide blood and skin swabs if they do not meet sampling criteria at the initial Screening Visit. A subset of participants from Natioanl Jewish Health may be asked to return to clinic for 2 additional visits approximately 7 and 14 days after the original sample collection for collection of skin swabs for assessment of antimicrobial activity. All participants may also be asked to return for an Unscheduled Visit to provide additional blood and/or skin swabs. Atopic Dermatitis with previous or current Eczema Herpeticum (ADEH+), Atopic Dermatitis with previous or current Eczema Vaccinatum (ADEV+) and Methicillin-Resistant S. Aureus (MRSA+) participants will be contacted every 6 months for the duration of the study.

We will target Non-Hispanic Caucasian, Non-Hispanic African American, and Mexican American because they constitute the three largest racial/ethnic populations according to the U.S. Census Bureau 2009 data; however, no racial/ethnic groups will be excluded. Our scientific rationale for targeting these three racial/ethnic groups is to ensure that we are able to recruit sufficient numbers of participants in each group to perform meaningful tests for genetic association.


Condition
Atopic Dermatitis
Eczema Herpeticum

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Registry for the Atopic Dermatitis Research Network (ADRN-02)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Genotype and sequence data from ADEH+ and ADEH- participants. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Genotype and sequence data from ADEH- participants with and without bacterial colonization with S. aureus. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Single Nucleotide Polymorphism (SNP) and Copy Number Variant (CNV) genotype data for candidate genes, including but not limited to Claudin-1 (CLDN1) and Filaggrin (FLG). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • SNP genotype data for candidate genes, including but not limited to CLDN1 and FLG, validated in samples from an independent AD population. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Targeted deep resequencing of candidate genes, including but not limited to CLDN1. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Analysis of S. aureus isolates for antibiotic sensitivity [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Analysis of S. aureus isolates for SCC mec DNA elements. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Analysis of S. aureus isolates for expression of virulence or other factors. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Expression of biomarkers, including but not limited to serum biomarkers, among AD sub-phenotypes. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Analysis of microbial composition by 16S rDNA amplicon sequencing. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Analysis of DNA methylation profiles [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Analysis of mRNA expression profiles in whole blood samples. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Frequency of commensal Staphylococcus species producing antimicrobial activity [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood DNA, whole blood RNA,blood cards, blood clots, serum, skin swabs, and skin swab isolates will be retained.


Estimated Enrollment: 2600
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ADEH-Staph+
Atopic Dermatitis without a history of Eczema Herpeticum and with S. aureus skin colonization. A minimum of 1100 participants will be enrolled; we will target 500 Non-Hispanic Caucasian, 300 Non-Hispanic African American, and 300 Mexican American Caucasian ADEH-Staph+ participants. Although we will target these three groups, no racial/ethnic groups will be excluded.
ADEH-Staph-
Atopic Dermatitis without a history of Eczema Herpeticum and without S. aureus skin colonization. A minimum of 1100 participants will be enrolled; we will target 500 Non-Hispanic Caucasian, 300 Non-Hispanic African American, and 300 Mexican American Caucasian ADEH-Staph- participants. Although we will target these three groups, no racial/ethnic groups will be excluded.
ADEH+
Atopic Dermatitis with previous or current Eczema Herpeticum.We will try to include a minimum of 150 Non-Hispanic Caucasian ADEH+ participants. ADEH+ participants of other racial/ethnic groups will not be excluded
ADEV+
Atopic Dermatitis with previous or current Eczema Vaccinatum.ADEV+ sub-phenotype is very rare so all eligible partticipants will be enrolled.
Non-atopic
Non-atopic healthy participants. A minimum of 250 non-atopic participants will be enrolled. Non-atopic participants will serve as a control group for the genetic, biomarker, Staph characterization, and microbiome studies.

  Eligibility

Ages Eligible for Study:   8 Months to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A minimum of 1100 ADEH-Staph+ participants and a minimum of 1100 ADEH-Staph- participants 3-80 years of age will be enrolled. In addition, ADEH+, ADEV+, and Non-atopic participants 8 months to 80 years of age will be enrolled.

It is unknown whether Staph colonization status will change as younger participants get older. For this reason, the lower age limit for inclusion of ADEH- participants is 3 years rather than 8 months to ensure that characterization of their Staph+ vs. Staph- state is more accurate

Criteria

Inclusion Criteria:

Participants who meet all of the following criteria are eligible for enrollment. Participants may be reassessed if not initially eligible.

  • ADEH+ and Non-atopic males and females ages 8 months to 80 years, inclusive, at the time of Enrollment, and ADEH- males and females ages 3 years to 80 years, inclusive, at the time of Enrollment.
  • Who are willing to sign the informed consent form or whose parent or legal guardian is willing to sign the informed consent form (age appropriate) prior to initiation of any study procedures.
  • Who are willing to sign the assent form, if age appropriate.
  • Who meet criteria for one of the diagnostic groups (ADEH-Staph+, ADEH-Staph-, ADEH+, ADEV+, Non-atopic) as defined in the ADRN Standard Diagnostic Criteria and the Staphylococcus aureus Colonization Criteria.

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for enrollment.

  • Who have an active systemic malignancy; uncomplicated non-melanoma skin cancer and melanoma in situ with documentation of complete excision are not exclusionary.
  • Who have any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
  • Who have a history of systemic immunological illness (e.g., immunodeficiency disorders such as human immunodeficiency virus [HIV] or lupus erythematosus) other than the condition being studied.
  • Who have a first degree relative already enrolled in the study.
  • Who are determined not to be eligible in the opinion of the Investigator.
  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: NCT01494142

Contacts
Contact: Judy Lairsmith 303-398-1067 lairsmithj@njhealth.org

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: ADRN Clinical Coordinator    323-361-4537    ADRN@chla.usc.edu   
Principal Investigator: Peck Ong, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: ADRN Clinical Coordinator    303-398-1409    ADRN@njhealth.org   
Principal Investigator: Donald Leung, MD, PhD         
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
Ann & Robert H. Lurie Children's Hospital of Chicago Active, not recruiting
Chicago, Illinois, United States, 60614
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: ADRN Clinical Coordinator    617-355-4344    ADRNStudy@childrens.harvard.edu   
Principal Investigator: Lynda Schneider, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: ADRN Clinical Coordinator    212-241-6033    ADRN@mssm.edu   
Principal Investigator: Emma Guttman, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: ADRN Clinical Coordinator    585-275-0374    ADRN@URMC.Rochester.edu   
Principal Investigator: Lisa Beck, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: ADRN Clinical Coordinator    503-228-7350    ADRN@ohsu.edu   
Principal Investigator: Jon Hanifin, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Terminated
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Study Chair: Lisa Beck, MD University of Rochester
Study Chair: Kathleen Barnes, PhD Johns Hopkins Asthma and Allergy Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01494142     History of Changes
Other Study ID Numbers: DAIT ADRN-02
Study First Received: October 31, 2011
Last Updated: July 10, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Registry
Atopic Dermatitis
Eczema Herpeticum
GWAS
Staphylococcus aureus

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Kaposi Varicelliform Eruption
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on September 18, 2014