Registry for the Atopic Dermatitis Research Network

Atopic Dermatitis Clinical Trial

Official title:

Registry for the Atopic Dermatitis Research Network (ADRN-02)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494142
• Other study ID #: DAIT ADRN-02
• Status: Completed
• Start date: August 2011
• Est. completion date: February 7, 2018

Study information

• Verified date: September 2018
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Other known NCT identifiers

• NCT00550316

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3387
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Months to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema Herpeticum

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Atopic Dermatitis Research Network

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gao L, Bin L, Rafaels NM, Huang L, Potee J, Ruczinski I, Beaty TH, Paller AS, Schneider LC, Gallo R, Hanifin JM, Beck LA, Geha RS, Mathias RA, Barnes KC, Leung DYM. Targeted deep sequencing identifies rare loss-of-function variants in IFNGR1 for risk of a — View Citation

Merriman JA, Mueller EA, Cahill MP, Beck LA, Paller AS, Hanifin JM, Ong PY, Schneider L, Babineau DC, David G, Lockhart A, Artis K, Leung DY, Schlievert PM. Temporal and Racial Differences Associated with Atopic Dermatitis Staphylococcusaureus and Encoded — View Citation

Nakatsuji T, Chen TH, Narala S, Chun KA, Two AM, Yun T, Shafiq F, Kotol PF, Bouslimani A, Melnik AV, Latif H, Kim JN, Lockhart A, Artis K, David G, Taylor P, Streib J, Dorrestein PC, Grier A, Gill SR, Zengler K, Hata TR, Leung DY, Gallo RL. Antimicrobials — View Citation

Nakatsuji T, Chen TH, Two AM, Chun KA, Narala S, Geha RS, Hata TR, Gallo RL. Staphylococcus aureus Exploits Epidermal Barrier Defects in Atopic Dermatitis to Trigger Cytokine Expression. J Invest Dermatol. 2016 Nov;136(11):2192-2200. doi: 10.1016/j.jid.20 — View Citation

Shi B, Bangayan NJ, Curd E, Taylor PA, Gallo RL, Leung DYM, Li H. The skin microbiome is different in pediatric versus adult atopic dermatitis. J Allergy Clin Immunol. 2016 Oct;138(4):1233-1236. doi: 10.1016/j.jaci.2016.04.053. Epub 2016 Jun 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotype and sequence data from ADEH+ and ADEH- participants.		Day 1
Primary	Genotype and sequence data from ADEH- participants with and without bacterial colonization with S. aureus.		Day 1
Secondary	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).		Day 1
Secondary	SNP genotype data for candidate genes, including but not limited to CLDN1 and FLG, validated in samples from an independent AD population.		Day 1
Secondary	Targeted deep resequencing of candidate genes, including but not limited to CLDN1.		Day 1
Secondary	Analysis of S. aureus isolates for antibiotic sensitivity		Day 1
Secondary	Analysis of S. aureus isolates for staphylococcal cassette chromosome (SCC) mec DNA elements.		Day 1
Secondary	Analysis of S. aureus isolates for expression of virulence or other factors.		Day 1
Secondary	Expression of biomarkers, including but not limited to serum biomarkers, among AD sub-phenotypes.		Day 1
Secondary	Analysis of microbial composition by 16S ribosomal Deoxyribonucleic Acid (rDNA) amplicon sequencing.		Day 1
Secondary	Analysis of DNA methylation profiles		Day 1
Secondary	Analysis of messenger Ribonucleic Acid (mRNA) expression profiles in whole blood samples.		Day 1
Secondary	Frequency of commensal Staphylococcus species producing antimicrobial activity		Day 1

External Links

•   Atopic Dermatitis Research Network (ADRN)
•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)