Atopic Dermatitis With a History of Eczema HerpeticumNCT04060550
Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum
An observational study of Atopic Dermatitis With a History of Eczema Herpeticum and Atopic Dermatitis Without a History of Eczema Herpeticum, run by National Jewish Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis With a History of Eczema Herpeticum, Atopic Dermatitis Without a History of Eczema Herpeticum, Health Controls Without Atopy
- What is being tested?
- Xolair
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Patricia Taylor, NP-C, 303-398-1067 ext. 1067, taylorp@njhealth.org
Lianghua Bin, MD & PhD
About this study
Official title: Investigate the Impact of Increased IgE on Innate Anti-herpes Simplex Virus 1 Responses in the Eczema Herpeticum Patients
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.
Read the 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
- Being tested
- Xolair
- Keywords
- Atopic dermatitis, Eczema herpeticum, Immunoglobulin E, Herpes simplex virus
- Medical subject headings
- Dermatitis, Atopic, Kaposi Varicelliform Eruption, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolairBiological
Also called omalizumab
This is in vitro mechanistic study. No drug will be given in vivo to patients.
| Study group | Role | What they receive |
|---|---|---|
| Normal controls | No history of skin disease and atopy Receives: Biological: Xolair | |
| ADEH- | Atopic dermatitis without a history of eczema herpeticum Receives: Biological: Xolair | |
| ADEH+ | Atopic dermatitis with a history of eczema herpeticum Receives: Biological: Xolair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocytes surface bound IgE quantities
Relative quantities of surface bound IgE
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start9 Jan 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis With a History of Eczema HerpeticumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060550
- Sponsor's protocol ID
- ML41620
- Status last verified
- Mar 2021
- First submitted
- 7 Aug 2019
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Impact of Increased IgE on Innate Anti-herpes Simplex Virus 1 Responses in the Eczema Herpeticum Patients
- ClinicalTrials.gov ID
- NCT04060550
- Acronym / sponsor ID
- ML41620
- Conditions
- Atopic Dermatitis With a History of Eczema Herpeticum, Atopic Dermatitis Without a History of Eczema Herpeticum, Health Controls Without Atopy
- Keywords
- Atopic dermatitis, Eczema herpeticum, Immunoglobulin E, Herpes simplex virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal controls | – | Biological: XolairNo history of skin disease and atopy |
| ADEH- | – | Biological: XolairAtopic dermatitis without a history of eczema herpeticum |
| ADEH+ | – | Biological: XolairAtopic dermatitis with a history of eczema herpeticum |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolairAlso: omalizumabThis is in vitro mechanistic study. No drug will be given in vivo to patients. | Biological | ADEH+, ADEH-, Normal controls |
Primary outcome
Monocytes surface bound IgE quantities
Time frame: One day
Relative quantities of surface bound IgE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis With a History of Eczema Herpeticum and Atopic Dermatitis Without a History of Eczema Herpeticum, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lianghua Bin, MD&PhD (3032702055, binl@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocytes surface bound IgE quantities (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.