Recruiting

Immunoglobulin E

Sponsor:

National Jewish Health

Code:

NCT04060550

Conditions

Atopic Dermatitis With a History of Eczema Herpeticum

Atopic Dermatitis Without a History of Eczema Herpeticum

Health Controls Without Atopy

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Accepted

Interventions

Xolair

Study Details

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.

Conditions

Atopic Dermatitis With a History of Eczema Herpeticum

Atopic Dermatitis Without a History of Eczema Herpeticum

Health Controls Without Atopy

Study ID

NCT04060550

Start date

Jan 9, 2020

Status verified date

Mar, 2021

Completion date

Jul 31, 2021

Anticipated

Primary completion date

Jul 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Accepted

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

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal controls

No history of skin disease and atopy

ADEH-

Atopic dermatitis without a history of eczema herpeticum

ADEH+

Atopic dermatitis with a history of eczema herpeticum

Interventions

Xolair

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

Primary outcome measure

  • Monocytes surface bound IgE quantities [ Time Frame: One day ]

Central Contacts and Locations

Central contacts

Lianghua Bin, MD&PhD

3032702055binl@njhealth.org

Donald Leung, MD&PhD

3033981886leungd@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Principal Investigator:

Lianghua Bin, MD & PhD

More Information

Sponsor

National Jewish Health

Last update posted

Mar 5, 2021

Last verified

Mar, 2021

Keywords

  • Atopic dermatitis
  • Eczema herpeticum
  • Immunoglobulin E
  • Herpes simplex virus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2021-03-05.