Atopic DermatitisNCT00438022
Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis
An observational study of Atopic Dermatitis and Eczema Herpeticum, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Germany.
Trial summary
Atopic Dermatitis (AD), also known as eczema, is a skin disease that causes the skin to be hot, dry and scaly, and have severe itching. There are different kinds of eczema. Eczema herpeticum (EH) is a type of eczema that spreads due to an underlying herpes virus infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema Herpeticum
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Jan 2010
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People of good general health, living in Germany
Who may be able to join
- Diagnosis of AD as defined by ADVN standardized diagnostic criteria who fall into one of the following categories:
- Recurrent, clinically manifested HSV infection with EH
- Recurrent, clinically manifested HSV infection without EH
- No recurrent, clinically manifested HSV infection or EH infection
- Residing in Germany
- Good general health other than having an atopic disease
- Caucasian
- Individuals between 18-60 years of age
Who cannot join
- Subjects with atopy but lacking stringent AD features, allowing only a presumptive diagnosis of AD
- Individuals under 18 or over 60 years of age
- Systemic immunosuppressive drugs or chemotherapy 30 days prior to study entry
- Oral and topical corticosteroids (including inhaled agents), antibiotics, antivirals, anti-inflammatory biologics (e.g., alefacept, etanercept), topical doxepin, topical coal tar preparations, or topical phosphodiesterase inhibitors 14 days prior to study entry
- Immunotherapy
- Antibiotics, antivirals, immune enhancers (e.g., imiquimod), or calcineurin inhibitors within 7 days prior to study entry
Show all 16Show fewer
- Phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA]) 30 days prior to study entry
- Cancer, autoimmune diseases, or immunodeficiency
- Active fungal, bacterial, or viral infections at screening
- Any skin diseases other than AD that might compromise the stratum corneum barrier (e.g., ichthyosis, bullous disease, psoriasis, skin cancer)
- Mental illness or a history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
- Inability or unwillingness of a subject to give written informed consent
- Weigh less than 40 kg (88.2 lb)
- Anxiolytic agents
- Antidepressants
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum
Atopic Dermatitis (AD), also known as eczema, is a skin disease that causes the skin to be hot, dry and scaly, and have severe itching. There are different kinds of eczema. Eczema herpeticum (EH) is a type of eczema that spreads due to an underlying herpes virus infection. The purpose of this research study is to identify the risk factors that may cause EH.
Read the detailed description
AD is characterized by chronic skin inflammation and infections. It is hypothesized that AD is caused by irritants in the environment and that symptoms of EH become worse with stress and changes in hormone levels. This study will examine skin cells collected from study participants to determine the risk factors for EH that are present in people with AD who develop EH.
This study will examine dendritic cells (DC) from the skin and blood of study participants to determine the differences between DCs of study participants. This study will recruit four types of participants:
- Group 1 will include participants with AD, EH, and recurrent herpes simplex virus (HSV)
- Group 2 will include participants with AD and recurring HSV infections but without EH
- Group 3 will include participants with AD but without EH or HSV infection
- Group 4 will include participants in good general health without AD, EH, or HSV infection
At the single study visit, skin and blood collection will occur.
- Conditions
- Atopic Dermatitis, Eczema Herpeticum
- Keywords
- Atopic Dermatitis, Eczema Herpeticum
- Medical subject headings
- Dermatitis, Atopic, Kaposi Varicelliform Eruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group 1 will include participants with AD, EH, and recurrent herpes simplex virus (HSV) | |
| 2 | Group 2 will include participants with AD and recurring HSV infections but without EH | |
| 3 | Group 3 will include participants with AD but without EH or HSV infection | |
| 4 | Group 4 will include participants in good general health without AD, EH, or HSV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendritic Cells.
Measured: 3 years
Secondary outcomes (5)
The capacity of myeloid and plasmacytoid DCs to produce IFN-α/IFN-β and of myeloid DCs to produce IL-10, IL-12, and IL-18 will be evaluated.
Measured: 3 years
Expression of HSV-receptors cluster of differentiation, costimulatory molecules, major histocompatibility complex, Toll-like receptor (TLR), and structures involved in antigen presentation of myeloid and plasmacytoid DCs.
Measured: 3 years
Evaluate the capacity of T-cells, stimulated and unstimulated myeloid DCs or plasmacytoid DCs to produce the T-helper cell 2 (Th2) cytokines IL-4, IL-5 and IL-13 and the T-helper cell 1 (Th1) cytokines IL-2 and IFN-γ and IL-10/TGF-β.
Measured: 3 years
The phenotype of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be evaluated by flow cytometry.
Measured: 3 years
The proliferation of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be measured with the help of flow cytometry by proliferating cell nuclear antigen.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startMar 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Atopic Dermatitis and Vaccinia Network
- Responsible party
- Sponsor
- Investigators
- Thomas Bieber, MD, PhD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438022
- Sponsor's protocol ID
- DAIT ADVN ADEH 06
- Other IDs
- HHSN266200400029C
- Status last verified
- Oct 2016
- First submitted
- 20 Feb 2007
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participant level data access is available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Peng WM, Yu CF, Allam JP, Oldenburg J, Bieber T, Hoch J, Eis-Hubinger AM, Novak N. Inhibitory oligodeoxynucleotides downregulate herpes simplex virus-induced plasmacytoid dendritic cell type I interferon production and modulate cell function. Hum Immunol. 2007 Nov;68(11):879-87. doi: 10.1016/j.humimm.2007.10.008. Epub 2007 Nov 5.
PubMed 18082566Hinz T, Zaccaro D, Byron M, Brendes K, Krieg T, Novak N, Bieber T. Atopic dermo-respiratory syndrome is a correlate of eczema herpeticum. Allergy. 2011 Jul;66(7):925-33. doi: 10.1111/j.1398-9995.2010.02538.x. Epub 2011 Jan 24.
PubMed 21255038
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum
- ClinicalTrials.gov ID
- NCT00438022
- Acronym / sponsor ID
- DAIT ADVN ADEH 06
- Conditions
- Atopic Dermatitis, Eczema Herpeticum
- Keywords
- Atopic Dermatitis, Eczema Herpeticum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Atopic Dermatitis and Vaccinia Network
- Study start
- Mar 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Feb 2007 (estimated)
- 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.
Atopic Dermatitis (AD), also known as eczema, is a skin disease that causes the skin to be hot, dry and scaly, and have severe itching. There are different kinds of eczema. Eczema herpeticum (EH) is a type of eczema that spreads due to an underlying herpes virus infection. The purpose of this research study is to identify the risk factors that may cause EH.
Detailed description
AD is characterized by chronic skin inflammation and infections. It is hypothesized that AD is caused by irritants in the environment and that symptoms of EH become worse with stress and changes in hormone levels. This study will examine skin cells collected from study participants to determine the risk factors for EH that are present in people with AD who develop EH.
This study will examine dendritic cells (DC) from the skin and blood of study participants to determine the differences between DCs of study participants. This study will recruit four types of participants:
- Group 1 will include participants with AD, EH, and recurrent herpes simplex virus (HSV)
- Group 2 will include participants with AD and recurring HSV infections but without EH
- Group 3 will include participants with AD but without EH or HSV infection
- Group 4 will include participants in good general health without AD, EH, or HSV infection
At the single study visit, skin and blood collection will occur.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Group 1 will include participants with AD, EH, and recurrent herpes simplex virus (HSV) |
| 2 | – | –Group 2 will include participants with AD and recurring HSV infections but without EH |
| 3 | – | –Group 3 will include participants with AD but without EH or HSV infection |
| 4 | – | –Group 4 will include participants in good general health without AD, EH, or HSV infection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People of good general health, living in Germany
Key inclusion criteria (8 listed)
- Diagnosis of AD as defined by ADVN standardized diagnostic criteria who fall into one of the following categories:
- Residing in Germany
- Good general health other than having an atopic disease
- Caucasian
- Individuals between 18-60 years of age
Key exclusion criteria (16 listed)
- Subjects with atopy but lacking stringent AD features, allowing only a presumptive diagnosis of AD
- Individuals under 18 or over 60 years of age
- Systemic immunosuppressive drugs or chemotherapy 30 days prior to study entry
- Oral and topical corticosteroids (including inhaled agents), antibiotics, antivirals, anti-inflammatory biologics (e.g., alefacept, etanercept), topical doxepin, topical coal tar preparations, or topical phosphodiesterase inhibitors 14 days prior to study entry
- Immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendritic Cells.
Time frame: 3 years
5 secondary outcomes
The capacity of myeloid and plasmacytoid DCs to produce IFN-α/IFN-β and of myeloid DCs to produce IL-10, IL-12, and IL-18 will be evaluated.
Time frame: 3 years
Expression of HSV-receptors cluster of differentiation, costimulatory molecules, major histocompatibility complex, Toll-like receptor (TLR), and structures involved in antigen presentation of myeloid and plasmacytoid DCs.
Time frame: 3 years
Evaluate the capacity of T-cells, stimulated and unstimulated myeloid DCs or plasmacytoid DCs to produce the T-helper cell 2 (Th2) cytokines IL-4, IL-5 and IL-13 and the T-helper cell 1 (Th1) cytokines IL-2 and IFN-γ and IL-10/TGF-β.
Time frame: 3 years
The phenotype of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be evaluated by flow cytometry.
Time frame: 3 years
The proliferation of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be measured with the help of flow cytometry by proliferating cell nuclear antigen.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Results publication: PubMed 18082566Peng WM, Yu CF, Allam JP, Oldenburg J, Bieber T, Hoch J, Eis-Hubinger AM, Novak N. Inhibitory oligodeoxynucleotides downregulate herpes simplex virus-induced plasmacytoid dendritic cell type I interferon production and modulate cell function. Hum Immunol. 2007 Nov;68(11):879-87. doi: 10.1016/j.humimm.2007.10.008. Epub 2007 Nov 5.
- Results publication: PubMed 21255038Hinz T, Zaccaro D, Byron M, Brendes K, Krieg T, Novak N, Bieber T. Atopic dermo-respiratory syndrome is a correlate of eczema herpeticum. Allergy. 2011 Jul;66(7):925-33. doi: 10.1111/j.1398-9995.2010.02538.x. Epub 2011 Jan 24.
- National Institute of Allergy and Infectious Diseases (NIAID) WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data access is available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Thomas Bieber, MD, PhD principal investigator
University of Bonn
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 and Eczema Herpeticum, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Germany.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 6 Oct 2016. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendritic Cells. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00438022, which also lists 2 linked publications.
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 6 Oct 2016.