Registry for the Atopic Dermatitis Research Network
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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 |
- 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 ]
- 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 |
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.
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| Contact: Judy Lairsmith | 303-270-2413 | lairsmithj@NJHealth.org |
| 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 | |
| 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:
|
Dermatitis Dermatitis, Atopic Eczema 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 May 22, 2013