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

Atopic Dermatitis With a History of Eczema Herpeticum Clinical Trial

Official title:

Investigate the Impact of Increased IgE on Innate Anti-herpes Simplex Virus 1 Responses in the Eczema Herpeticum Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04060550
• Other study ID #: ML41620
• Status: Recruiting
• Start date: January 9, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2021
• Source: National Jewish Health
• Contact: Lianghua Bin, MD&PhD
• Phone: 3032702055
• Email: binl[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis With a History of Eczema Herpeticum
• Atopic Dermatitis Without a History of Eczema Herpeticum
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Health Controls Without Atopy
• Herpes Simplex

Intervention

Biological:
• Xolair
This is in vitro mechanistic study. No drug will be given in vivo to patients.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocytes surface bound IgE quantities	Relative quantities of surface bound IgE	One day