Etiology of Eczema Herpeticum (EH)



Status:Recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:3 - 64
Updated:3/15/2019
Start Date:February 22, 2017
End Date:June 2020

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Integrated Extreme Trait Analysis to Understand the Etiology of Eczema Herpeticum (ADRN-06)

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.

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.

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.
We found this trial at
1
site
1400 Jackson Street
Denver, Colorado 80206
Phone: 303-398-1409
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mi
from
Denver, CO
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