Registry for the Atopic Dermatitis Research Network
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|ClinicalTrials.gov Identifier: NCT01494142|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : September 19, 2018
|Condition or disease|
|Atopic Dermatitis Eczema Herpeticum|
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 National 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.
Recruitment emphasis will include Non-Hispanic Caucasian, Non-Hispanic African American, and Mexican American since these 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.
|Study Type :||Observational|
|Actual Enrollment :||3387 participants|
|Official Title:||Registry for the Atopic Dermatitis Research Network (ADRN-02)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 7, 2018|
|Actual Study Completion Date :||February 7, 2018|
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.
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.
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
Atopic Dermatitis with previous or current Eczema Vaccinatum. ADEV+ sub-phenotype is very rare so all eligible participants will be enrolled.
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.
- Genotype and sequence data from ADEH+ and ADEH- participants. [ Time Frame: Day 1 ]
- Genotype and sequence data from ADEH- participants with and without bacterial colonization with S. aureus. [ Time Frame: Day 1 ]
- 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 ]
- 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 ]
- Targeted deep resequencing of candidate genes, including but not limited to CLDN1. [ Time Frame: Day 1 ]
- Analysis of S. aureus isolates for antibiotic sensitivity [ Time Frame: Day 1 ]
- Analysis of S. aureus isolates for staphylococcal cassette chromosome (SCC) mec DNA elements. [ Time Frame: Day 1 ]
- Analysis of S. aureus isolates for expression of virulence or other factors. [ Time Frame: Day 1 ]
- Expression of biomarkers, including but not limited to serum biomarkers, among AD sub-phenotypes. [ Time Frame: Day 1 ]
- Analysis of microbial composition by 16S ribosomal Deoxyribonucleic Acid (rDNA) amplicon sequencing. [ Time Frame: Day 1 ]
- Analysis of DNA methylation profiles [ Time Frame: Day 1 ]
- Analysis of messenger Ribonucleic Acid (mRNA) expression profiles in whole blood samples. [ Time Frame: Day 1 ]
- Frequency of commensal Staphylococcus species producing antimicrobial activity [ Time Frame: Day 1 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494142
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Lisa Beck, MD||University of Rochester|
|Study Chair:||Kathleen Barnes, PhD||Johns Hopkins Asthma and Allergy Center|