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

NCT ID: NCT04060550

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2021-07-31

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.

Conditions

Atopic Dermatitis With a History of Eczema Herpeticum; Atopic Dermatitis Without a History of Eczema Herpeticum; Health Controls Without Atopy

Study Design

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

Study Groups

Normal controls

No history of skin disease and atopy

Xolair

Intervention Type: BIOLOGICAL

This is in vitro mechanistic study. No drug will be given in vivo to patients.

ADEH-

Atopic dermatitis without a history of eczema herpeticum

Xolair

Intervention Type: BIOLOGICAL

This is in vitro mechanistic study. No drug will be given in vivo to patients.

ADEH+

Atopic dermatitis with a history of eczema herpeticum

Xolair

Intervention Type: BIOLOGICAL

This is in vitro mechanistic study. No drug will be given in vivo to patients.

Interventions

Xolair

This is in vitro mechanistic study. No drug will be given in vivo to patients.

Intervention Type: BIOLOGICAL

Other Intervention Names

omalizumab

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Jewish Health

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lianghua Bin, MD&PhD

Role: CONTACT

binl@njhealth.org

3032702055

Donald Leung, MD&PhD

Role: CONTACT

leungd@njhealth.org

3033981886

Facility Contacts

Patricia Taylor, NP-C

Role: primary

taylorp@njhealth.org

303-398-1067 ext. 1067

Other Identifiers

ML41620

Identifier Type: -

Identifier Source: org_study_id