Atopic DermatitisGeneticsNCT00515047
Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH) following exposure to the herpes simplex virus (HSV). Read more about this study
- Who is it for?
- Ages 8 months to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 900 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2006to Jan 2011
- 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 8 months to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: African-American, Caucasian, and Non-Hispanic people ages 8 months to 80 years
Who may be able to join
- Enrollment in ADVN Biomarker Registry Study
- Non-Hispanic and only African American or only Caucasian race
- Parent or guardian willing to provide informed consent, if necessary
Who cannot join
- History of any systemic illness, excluding AD
- Participation of a first degree relative already enrolled in the genotyping study unless the subject in question fulfills the diagnostic criteria for ADEH+. More information on this criterion can be found in the protocol.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Children's Memorial Hospital
Chicago, Illinois
Northwestern University
Chicago, Illinois
National Jewish Health
Denver, Colorado, 80206
University of California at San Diego
La Jolla, California, 92037
Oregon Health & Sciences University
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Genetics of Atopic Dermatitis - Eczema Herpeticum
People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH) following exposure to the herpes simplex virus (HSV). The purpose of this study is to identify the genetic determinants that lead people with AD to develop EH and similar conditions caused by other viruses.
Read the detailed description
AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. However, people with AD do not all develop the same infections. For example, some people with AD who receive the smallpox vaccine develop a life-threatening condition known as eczema vaccinatum (EV). This study focuses on individuals with AD who also have a history of eczema herpeticum (ADEH+), a condition similar to EV. It is unlikely that the differences in the development of skin infections are due to differences in viral exposure, and instead due to differences in each individual's response to viruses. The purpose of this study is to determine the genetic pathways which are responsible for the development of viral skin infections in people with AD.
Participants in this study will also be enrolled in the ADVN Biomarker Registry Study. There will be only one clinical visit for this study at which blood and/or skin samples may be collected. The samples will then have high-throughput genotyping to define genetic markers in individuals susceptible to viral infections.
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Eczema, Eczema Herpeticum, Molluscum Contagiousum, Herpes Simplex, Vaccinia
- Medical subject headings
- Dermatitis, Atopic, Eczema, Kaposi Varicelliform Eruption, Herpes Simplex, Vaccinia
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 |
|---|---|---|
| Eczema Herpeticum (EH) | Participants with AD who currently have or have had EH | |
| Non-EH | Participants with AD who do not have and have never had EH | |
| Healthy Controls | Healthy participants without a history of AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH
Measured: Throughout Study
Secondary outcomes (1)
Identification and prioritization of novel genes induced in response to viral infection (HSV/Vaccinia and MCV) in AD participants and relevant control groups
Measured: Throughout Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startMay 2006
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa Beck, MD, Principal investigator, University of RochesterKathleen Barnes, PhD, Principal investigator, Johns Hopkins Allergy and Asthma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515047
- Sponsor's protocol ID
- DAIT ADVN GENE 04
- Other IDs
- HHSN266200400033
- Acronym
- Genetics
- Status last verified
- Apr 2014
- First submitted
- 10 Aug 2007
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baker BS. The role of microorganisms in atopic dermatitis. Clin Exp Immunol. 2006 Apr;144(1):1-9. doi: 10.1111/j.1365-2249.2005.02980.x.
PubMed 16542358Kim BE, Leung DY, Streib JE, Kisich K, Boguniewicz M, Hamid QA, Howell MD. Macrophage inflammatory protein 3alpha deficiency in atopic dermatitis skin and role in innate immune response to vaccinia virus. J Allergy Clin Immunol. 2007 Feb;119(2):457-63. doi: 10.1016/j.jaci.2006.10.005. Epub 2006 Dec 4.
PubMed 17141855Porter CD, Muhlemann MF, Cream JJ, Archard LC. Molluscum contagiosum: characterization of viral DNA and clinical features. Epidemiol Infect. 1987 Oct;99(2):563-6. doi: 10.1017/s0950268800068072.
PubMed 2824227Umene K, Yoshida M, Sakaoka H. Comparison of the association with eczema herpeticum in the two predominant genotypes of herpes simplex virus type 1. J Med Virol. 1996 Aug;49(4):329-32. doi: 10.1002/(SICI)1096-9071(199608)49:43.0.CO;2-5.
PubMed 8877767Gao PS, Leung DY, Rafaels NM, Boguniewicz M, Hand T, Gao L, Hata TR, Schneider LC, Hanifin JM, Beaty TH, Beck LA, Weinberg A, Barnes KC. Genetic variants in interferon regulatory factor 2 (IRF2) are associated with atopic dermatitis and eczema herpeticum. J Invest Dermatol. 2012 Mar;132(3 Pt 1):650-7. doi: 10.1038/jid.2011.374. Epub 2011 Nov 24.
PubMed 22113474Gao PS, Rafaels NM, Mu D, Hand T, Murray T, Boguniewicz M, Hata T, Schneider L, Hanifin JM, Gallo RL, Gao L, Beaty TH, Beck LA, Leung DY, Barnes KC. Genetic variants in thymic stromal lymphopoietin are associated with atopic dermatitis and eczema herpeticum. J Allergy Clin Immunol. 2010 Jun;125(6):1403-1407.e4. doi: 10.1016/j.jaci.2010.03.016. Epub 2010 May 13. No abstract available.
PubMed 20466416
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Atopic Dermatitis - Eczema Herpeticum
- ClinicalTrials.gov ID
- NCT00515047
- Acronym / sponsor ID
- Genetics / DAIT ADVN GENE 04
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Eczema, Eczema Herpeticum, Molluscum Contagiousum, Herpes Simplex, Vaccinia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- May 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Aug 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.
People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH) following exposure to the herpes simplex virus (HSV). The purpose of this study is to identify the genetic determinants that lead people with AD to develop EH and similar conditions caused by other viruses.
Detailed description
AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. However, people with AD do not all develop the same infections. For example, some people with AD who receive the smallpox vaccine develop a life-threatening condition known as eczema vaccinatum (EV). This study focuses on individuals with AD who also have a history of eczema herpeticum (ADEH+), a condition similar to EV. It is unlikely that the differences in the development of skin infections are due to differences in viral exposure, and instead due to differences in each individual's response to viruses. The purpose of this study is to determine the genetic pathways which are responsible for the development of viral skin infections in people with AD.
Participants in this study will also be enrolled in the ADVN Biomarker Registry Study. There will be only one clinical visit for this study at which blood and/or skin samples may be collected. The samples will then have high-throughput genotyping to define genetic markers in individuals susceptible to viral infections.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eczema Herpeticum (EH) | – | –Participants with AD who currently have or have had EH |
| Non-EH | – | –Participants with AD who do not have and have never had EH |
| Healthy Controls | – | –Healthy participants without a history of AD |
Who may qualify
- Ages
- 8 months to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- African-American, Caucasian, and Non-Hispanic people ages 8 months to 80 years
Key inclusion criteria (3 listed)
- Enrollment in ADVN Biomarker Registry Study
- Non-Hispanic and only African American or only Caucasian race
- Parent or guardian willing to provide informed consent, if necessary
Key exclusion criteria (2 listed)
- History of any systemic illness, excluding AD
- Participation of a first degree relative already enrolled in the genotyping study unless the subject in question fulfills the diagnostic criteria for ADEH+. More information on this criterion can be found in the protocol.
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
Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH
Time frame: Throughout Study
1 secondary outcome
Identification and prioritization of novel genes induced in response to viral infection (HSV/Vaccinia and MCV) in AD participants and relevant control groups
Time frame: Throughout Study
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 2 Apr 2014.
- Background: PubMed 16542358Baker BS. The role of microorganisms in atopic dermatitis. Clin Exp Immunol. 2006 Apr;144(1):1-9. doi: 10.1111/j.1365-2249.2005.02980.x.
- Background: PubMed 17141855Kim BE, Leung DY, Streib JE, Kisich K, Boguniewicz M, Hamid QA, Howell MD. Macrophage inflammatory protein 3alpha deficiency in atopic dermatitis skin and role in innate immune response to vaccinia virus. J Allergy Clin Immunol. 2007 Feb;119(2):457-63. doi: 10.1016/j.jaci.2006.10.005. Epub 2006 Dec 4.
- Background: PubMed 2824227Porter CD, Muhlemann MF, Cream JJ, Archard LC. Molluscum contagiosum: characterization of viral DNA and clinical features. Epidemiol Infect. 1987 Oct;99(2):563-6. doi: 10.1017/s0950268800068072.
- Background: PubMed 8877767Umene K, Yoshida M, Sakaoka H. Comparison of the association with eczema herpeticum in the two predominant genotypes of herpes simplex virus type 1. J Med Virol. 1996 Aug;49(4):329-32. doi: 10.1002/(SICI)1096-9071(199608)49:43.0.CO;2-5.
- Results publication: PubMed 22113474Gao PS, Leung DY, Rafaels NM, Boguniewicz M, Hand T, Gao L, Hata TR, Schneider LC, Hanifin JM, Beaty TH, Beck LA, Weinberg A, Barnes KC. Genetic variants in interferon regulatory factor 2 (IRF2) are associated with atopic dermatitis and eczema herpeticum. J Invest Dermatol. 2012 Mar;132(3 Pt 1):650-7. doi: 10.1038/jid.2011.374. Epub 2011 Nov 24.
- Results publication: PubMed 20466416Gao PS, Rafaels NM, Mu D, Hand T, Murray T, Boguniewicz M, Hata T, Schneider L, Hanifin JM, Gallo RL, Gao L, Beaty TH, Beck LA, Leung DY, Barnes KC. Genetic variants in thymic stromal lymphopoietin are associated with atopic dermatitis and eczema herpeticum. J Allergy Clin Immunol. 2010 Jun;125(6):1403-1407.e4. doi: 10.1016/j.jaci.2010.03.016. Epub 2010 May 13. No abstract available.
- Click here for more information about the Atopic Dermatitis and Vaccinia NetworkLink provided by the sponsor.
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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.
Lisa Beck, MD principal investigator
University of Rochester
Kathleen Barnes, PhD principal investigator
Johns Hopkins Allergy and Asthma Center
7 sites 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, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites 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 3 inclusion and 2 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 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH (time frame: Throughout Study). 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 NCT00515047, which also lists 6 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 2 Apr 2014.