Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum

• Conditions: Health Controls Without Atopy; Atopic Dermatitis With a History of Eczema Herpeticum; Atopic Dermatitis Without a History of Eczema Herpeticum
• Interventions: Biological: Xolair

• Registration Number: NCT04060550
• Lead Sponsor: National Jewish Health

Brief Summary

This study investigates whether blood monocytes' surface bound- immunoglobulin E affects the innate immune responses against herpes simplex viruses in atopic dermatitis patients with eczema herpeticum.

Detailed Description

Some of atopic dermatitis patients (AD) have severe herpes simplex viral (HSV) infections, which could cause erosive skin lesions all over the body. This condition is termed as eczema herpeticum (ADEH+). Scientists have found that ADEH+ patients have significantly increased blood immunoglobulin (Ig) E compared to AD patients without eczema herpeticum and healthy people. Increased IgE in blood could bound to immune cells' surface, such as monocytes. Since monocytes serve as the first line defense to fight viral infection, their surface-bound IgE may interfere their anti-viral immune responses, and consequently results in more severe viral infections. The purpose of this study is to learn more about how increased IgE affect body's immune ability to fight herpes simplex viruses. This study includes three groups: AD patient without eczema herpeticum complication(ADEH-); AD patient with eczema herpeticum complication(ADEH+) and healthy controls. Study results will be compared between groups.

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Study Start: 2020-01-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-05
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age 16-65 years old, age, sex and race match among non-atopic, ADEH- and ADEH+.

• Participant and/or parent guardian must be able to understand and provide informed consent, and fits in one of the following conditions:

  1. A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.
  2. A history of AD without a history of eczema herpeticum, ADEH-, as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria, and no first degree relatives with a history of EH.
  3. Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.

Exclusion Criteria

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• Known or suspected immunosuppression
• Severe concomitant illness(es)
• Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
• Known sensitivity to study drug(s) or class of study drug(s)
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
• Use of any other investigational agent in the last 30 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal controls	Xolair	No history of skin disease and atopy
ADEH-	Xolair	Atopic dermatitis without a history of eczema herpeticum
ADEH+	Xolair	Atopic dermatitis with a history of eczema herpeticum

Primary Outcome Measures

Name	Time	Method
Monocytes surface bound IgE quantities	One day	Relative quantities of surface bound IgE

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States