Registry for the Atopic Dermatitis Research Network

This study is currently recruiting participants.
Verified September 2012 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: September 27, 2012
Last verified: September 2012
  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. 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+) and Atopic Dermatitis with previous or current Eczema Vaccinatum (ADEV+) participants will be contacted every 6 months for the duration of the study.


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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Expand the database of clinical and diagnostic information on participants with AD from the Atopic Dermatitis Vaccinia Network. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Genetic variants associated with susceptibility of AD patients to cutaneous viral dissemination. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Genetic variants associated with susceptibility of ADEH- patients to bacterial colonization and/or infection with S. aureus. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AD patients' S. aureus isolate characterization for factors including but not limited to antibiotic resistance and virulence factors. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Creation of a repository of serum samples for assessment of biomarkers associated with atopic dermatitis or susceptibility to cutaneous colonization and/or infections. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • The diversity of bacterial species in the skin microbiome of AD patients versus non-atopic individuals. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • S. aureus colonization effect on the susceptibility to colonization and infection with other organisms in ADEH- patients. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • EH infection effect on the susceptibility to colonization and infection with other organisms in AD patients. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 2200
Study Start Date: August 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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.
ADEH-Staph-
Atopic Dermatitis without a history of Eczema Herpeticum and without S. aureus skin colonization.
ADEH+
Atopic Dermatitis with previous or current Eczema Herpeticum.
ADEV+
Atopic Dermatitis with previous or current Eczema Vaccinatum.
Non-atopic
Non-atopic healthy control.

  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.

Criteria

Inclusion Criteria:

  • ADEH+ and Non-atopic males and females ages 8 month to 80 years, inclusive, at the time of Recruitment, and ADEH- males and females ages 3 years to 80 years, inclusive, at the time of Recruitment.
  • 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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494142

Contacts
Contact: Judy Lairsmith 303-270-2413 lairsmithj@NJHealth.org

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Sandra Figueroa     323-361-4537     sfigueroa@chla.usc.edu    
Contact: Dalila Ortega     323-361-4537     dlopez@chla.usc.edu    
Principal Investigator: Peck Ong, MD            
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Patricia Taylor     303-398-1067     taylorp@NJHealth.org    
Contact: Judy Lairsmith     303-270-2413     lairsmithj@NJHealth.org    
Principal Investigator: Donald Leung, MD, PhD            
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Victoria Godinez-Puig, MD     312-227-6484     victoria.godinez-puig@northwestern.edu    
Principal Investigator: Amy Paller, MD            
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Victoria Godinez-Puig, MD     312-227-6484     victoria.godinez-puig@northwestern.edu    
Principal Investigator: Amy Paller, MD            
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Heughan     617-355-6127     lisa.heughan@childrens.harvard.edu    
Principal Investigator: Lynda Schneider, MD            
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jean Sauvain     585-275-0374     jean_sauvain@urmc.rochester.edu    
Principal Investigator: Lisa Beck, MD            
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Emma Hill     503-494-4770     hillem@ohsu.ed    
Principal Investigator: Jon Hanifin, MD            
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: ADRN-02
Study First Received: October 31, 2011
Last Updated: September 27, 2012
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:
Hypersensitivity, Immediate
Hypersensitivity
Dermatitis
Dermatitis, Atopic
Eczema
Kaposi Varicelliform Eruption
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on May 23, 2013