Etiology of Eczema Herpeticum (EH)

NCT ID: NCT03038932

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2020-11-24

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.

Detailed Description

This study uses whole genome sequencing (WGS) technology to identify genetic variants that confer risk of recurrent atopic dermatitis with a history of eczema herpeticum (ADEH+), with ≥3 eczema herpeticum (EH) episodes.

A small subgroup of individuals with atopic dermatitis (AD) suffer from life-threatening disseminated herpes simplex virus (HSV) skin infections, termed eczema herpeticum (ADEH+). The manifestation of ADEH+ however is not simply a consequence of herpes simplex virus type 1 (HSV-1) infections, since the majority of the US population is latently infected with HSV-1 from an early age. Most importantly, there is a bimodality in the recurrence of eczema herpeticum (EH) episodes; most individuals have only a single episode but a subgroup of ADEH+ individuals has 3 or more episodes.

This study aims to conduct an extreme trait investigation of ADEH+ with recurrent EH, ≥3 episodes, compared to AD without a history of eczema herpeticum (ADEH-), using whole genome sequencing.

Conditions

Eczema Herpeticum

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Must be a participant already enrolled in the ADRN Registry and provided DNA (ClinicalTrials.gov ID: NCT01494142);

2. Participant and/or parent guardian must be able to understand and provide informed consent;

3. 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)

OR

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

OR

Non-atopic as diagnosed using the ADRN Standard Diagnostic Criteria.

4. Anti-Herpes Simplex Virus (HSV)-1 or Anti-HSV-2 Immunoglobulin G (IgG) seropositive.

Exclusion Criteria

1. Inability or unwillingness of a participant and/or parent guardian to give written informed consent or comply with study protocol;

2. Pregnant or lactating women;

3. Known or suspected immunosuppression;

4. Severe concomitant illness(es);

5. History of keloid formation (adults only);

6. History of lidocaine or Novocain allergy (adults only);

7. History of serious life-threatening reaction to latex, tape, or adhesives;

8. 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.

9. Use of biologics within 5 half-lives (if known) or 16 weeks of the Screening Visit;

10. Use of an investigational drug within 5 half-lives (if known) or 8 weeks of the Screening Visit.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atopic Dermatitis Research Network

OTHER

Sponsor Role: collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald Leung, M.D., Ph.D.

Role: STUDY_CHAIR

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Locations

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, United States

Countries

United States

Related Links

https://clinicaltrials.gov/ct2/show/NCT01494142

ClinicalTrials.gov Record for Atopic Dermatitis Research Network Registry

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID) website

https://www.niaid.nih.gov/research/atopic-dermatitis-research-network

Atopic Dermatitis Research Network (ADRN) information

Other Identifiers

DAIT ADRN-06

Identifier Type: -

Identifier Source: org_study_id