NCT04060550

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 9, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

August 7, 2019

Last Update Submit

March 4, 2021

Conditions

Atopic Dermatitis With a History of Eczema HerpeticumAtopic Dermatitis Without a History of Eczema HerpeticumHealth Controls Without Atopy

Keywords

Atopic dermatitisEczema herpeticumImmunoglobulin EHerpes simplex virus

Outcome Measures

Primary Outcomes (1)

  • Monocytes surface bound IgE quantities

    Relative quantities of surface bound IgE

    One day

Study Arms (3)

Normal controls

No history of skin disease and atopy

Biological: Xolair

ADEH-

Atopic dermatitis without a history of eczema herpeticum

Biological: Xolair

ADEH+

Atopic dermatitis with a history of eczema herpeticum

Biological: Xolair

Interventions

XolairBIOLOGICAL

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

Also known as: omalizumab
ADEH+ADEH-Normal controls

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One of the following groups: 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.

You may qualify if:

  • 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:
  • A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.
  • 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.
  • Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood, monocytes purified from peripheral blood

MeSH Terms

Conditions

Dermatitis, AtopicKaposi Varicelliform EruptionHerpes Simplex

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, Infectious

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Central Study Contacts

Lianghua Bin, MD&PhD

CONTACT

3032702055binl@njhealth.org

Donald Leung, MD&PhD

CONTACT

3033981886leungd@njhealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 19, 2019

Study Start

January 9, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

US(1)