Etiology of Eczema Herpeticum (EH)

NCT03038932 | Completed

• 1 other identifier: DAIT ADRN-06
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis, also called eczema, is a disease with dry, scaly, itchy skin. Those with atopic dermatitis may have complications from skin infections such as eczema herpeticum after herpes simplex virus (HSV) infection. Symptoms of eczema herpeticum include fever and clusters of itchy blisters which crust over and form sores. Although exposure to HSV is widespread, most people clear the virus and only a subset of individuals with atopic dermatitis develop eczema herpeticum. The purpose of this study is to determine why some individuals with atopic dermatitis are at higher risk for recurrent skin infections with HSV. The study team will compare how people with atopic dermatitis with a history of recurrent eczema herpeticum, people with atopic dermatitis without a history of eczema herpeticum, and people without atopic dermatitis respond to HSV.

Conditions

Eczema Herpeticum

Keywords

whole genome sequencing (WGS)

Outcome Measures

Primary Outcomes (2)

• The Difference in Frequency of Rare Deleterious Coding Genetic Variants between Subjects with Recurrent Atopic Dermatitis (AD) and a History of Eczema Herpeticum (ADEH+) Compared to Controls - Using Whole Genome Sequencing

  Whole genome sequencing methodology will be used to identify differences in frequency of rare deleterious coding genetic variants between recurrent Atopic Dermatitis (AD) subjects with a history of Eczema Herpeticum (ADEH+) and ≥3 Eczema Herpeticum (EH) episodes, versus controls. Controls will include (1) AD subjects without a history of EH (ADEH-); (2) non-atopic (NA) subjects without AD; and (3) general population controls from the Thousand Genomes Project.

  3 years

• The Difference in Frequency of Rare Deleterious Non-Coding Genetic Variants between Subjects with Recurrent Atopic Dermatitis (AD) and a History of Eczema Herpeticum (ADEH+) Compared to Controls - Using Whole Genome Sequencing

  Whole genome sequencing methodology will be used to identify differences in frequency of rare deleterious non-coding genetic variants between subjects with recurrent Atopic Dermatitis (AD) subjects and a history of Eczema Herpeticum (ADEH+) with ≥3 Eczema Herpeticum (EH) episodes, versus controls. Controls will include (1) AD subjects without a history of EH (ADEH-); (2) non-atopic (NA) subjects without AD; and (3) general population controls from the Thousand Genomes Project.

  3 years

Secondary Outcomes (27)

• Gene expression profiles in the dermis

  3 years

• Gene expression profiles in the epidermis

  3 years

• Gene expression profiles in in keratinocytes

  3 years

• Gene expression profiles in fibroblasts

  3 years

• Gene expression profiles in peripheral blood Plasmacytoid Dendritic Cells(pDCs)

  3 years

Study Arms (2)

Discovery Cohort

A minimum of 50 recurrent Atopic Dermatitis with a history of Eczema Herpeticum(ADEH+), 500 Atopic Dermatitis without a history of Eczema Herpeticum (ADEH-), and 237 Non-Atopic (NA) European American participants from the Atopic Dermatitis Research Network (ADRN) DNA Repository. The study will learn from this cohort: 1. All Single Nucleotide Variants (SNVs) in ADEH+ 2. ADEH+ specific deleterious SNVs The study will determine the function of: 4\. ADEH+ risk variants

Independent populations of participants

Two independent populations of participants: 1. Children, aged 3-17 years and 2. Adults 18-64 years of age. A minimum of 12 recurrent Atopic Dermatitis with a history of Eczema Herpeticum (ADEH+) with ≥3 Eczema Herpeticum (EH) episodes, 12 Atopic Dermatitis without a history of Eczema Herpeticum (ADEH-) and 12 Non-Atopic (NA) participants will be enrolled in each of the two populations.

Eligibility Criteria

• Age: 3 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 50 recurrent Atopic Dermatitis with a history of Eczema Herpeticum(ADEH+), 500 Atopic Dermatitis without a history of Eczema Herpeticum (ADEH-), and 237 Non-Atopic (NA) European American participants from the Atopic Dermatitis Research Network (ADRN) DNA Repository. The protocol will also enroll two independent populations of participants 1) children, 3-17 years of age and 2) adults 18-64 years of age. A minimum of 12 recurrent ADEH+ with ≥3 EH episodes, 12 ADEH- and 12 NA participants will be enrolled in each of the two populations.

You may qualify if:

• Must be a participant already enrolled in the ADRN Registry and provided DNA (ClinicalTrials.gov ID: NCT01494142);
• Participant and/or parent guardian must be able to understand and provide informed consent;
• A history of Atopic Dermatitis (AD) with a history of eczema herpeticum (ADEH+), as diagnosed using the Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria, with ≥3 episodes of Eczema Herpeticum (EH)
• A history of AD without a history of eczema herpeticum (ADEH-), as diagnosed using the ADRN Standard Diagnostic Criteria, and no immediate family members (mother, father, full siblings, half-siblings, offspring, aunts, uncles, cousins, or grandparents) with a history of EH
• Non-atopic as diagnosed using the ADRN Standard Diagnostic Criteria.
• Anti-Herpes Simplex Virus (HSV)-1 or Anti-HSV-2 Immunoglobulin G (IgG) seropositive.

You may not qualify if:

• Inability or unwillingness of a participant and/or parent guardian to give written informed consent or comply with study protocol;
• Pregnant or lactating women;
• Known or suspected immunosuppression;
• Severe concomitant illness(es);
• History of keloid formation (adults only);
• History of lidocaine or Novocain allergy (adults only);
• History of serious life-threatening reaction to latex, tape, or adhesives;
• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
• Use of biologics within 5 half-lives (if known) or 16 weeks of the Screening Visit;
• Use of an investigational drug within 5 half-lives (if known) or 8 weeks of the Screening Visit.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis Research Network: collaborator
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (1)

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, 80206, United States

Location

Related Links

• ClinicalTrials.gov Record for Atopic Dermatitis Research Network Registry
• National Institute of Allergy and Infectious Diseases (NIAID) website
• Atopic Dermatitis Research Network (ADRN) information

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Skin Tissue

MeSH Terms

Conditions

Kaposi Varicelliform Eruption

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Donald Leung, M.D., Ph.D.

  National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 1, 2017
• Study Start: February 22, 2017
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1)