Atopic Dermatitis, Serum Skin TestNCT01238263
Autologous Serum Skin Testing in Patients With Atopic Dermatitis Autologous Serum Skin Testing in Patients With Atopic Dermatitis
An observational study of Atopic Dermatitis, Serum Skin Test, run by Yuzuncu Yil University.
Trial summary
Recently, IgE-type autoantibodies against self proteins have been detected in the serum of the atopic dermatitis patients. The role of this IgE autoantibodies involved in the pathogenesis of atopic dermatitis is not known, yet. Read more about this study
- Who is it for?
- Ages 1 year to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Serum Skin Test
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Aug 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 1 year to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 90
Who may be able to join
- Sixty AD patients and 30 healthy individuals
Who cannot join
- . The patients showing evidence of any other disease are not included to our study. No drug was allowed fourteen days prior to the test, including antihistamines and steroids.
About this study
Recently, IgE-type autoantibodies against self proteins have been detected in the serum of the atopic dermatitis patients. The role of this IgE autoantibodies involved in the pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between the severity of the disease and the serum levels of this autoantibodies. The autologous serum skin testing is applied to both atopic dermatitis patients and healthy control and the results are estimated in this study.The investigators detected 70% positive autologous serum skin testing in atopic dermatitis patients and test positivity was higher in patients with atopy history, moderately severe disease calculated by SCORAD index and high serum IgE levels.
- Conditions
- Atopic Dermatitis, Serum Skin Test
- Keywords
- Atopic dermatitis, autologous serum skin testing, IgE autoantibodies
- Medical subject headings
- Dermatitis, Atopic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis, Serum Skin TestStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238263
- Sponsor's protocol ID
- yavuzyesilova
- Status last verified
- May 2009
- First submitted
- 9 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Serum Skin Testing in Patients With Atopic Dermatitis Autologous Serum Skin Testing in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01238263
- Acronym / sponsor ID
- yavuzyesilova
- Conditions
- Atopic Dermatitis, Serum Skin Test
- Keywords
- Atopic dermatitis, autologous serum skin testing, IgE autoantibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Nov 2010 (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.
Recently, IgE-type autoantibodies against self proteins have been detected in the serum of the atopic dermatitis patients. The role of this IgE autoantibodies involved in the pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between the severity of the disease and the serum levels of this autoantibodies. The autologous serum skin testing is applied to both atopic dermatitis patients and healthy control and the results are estimated in this study.The investigators detected 70% positive autologous serum skin testing in atopic dermatitis patients and test positivity was higher in patients with atopy history, moderately severe disease calculated by SCORAD index and high serum IgE levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 90
Key inclusion criteria (1 listed)
- Sixty AD patients and 30 healthy individuals
Key exclusion criteria (1 listed)
- . The patients showing evidence of any other disease are not included to our study. No drug was allowed fourteen days prior to the test, including antihistamines and steroids.
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
Not reported in the source record.
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 10 Nov 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, Serum Skin Test, run by Yuzuncu Yil University.
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 1 inclusion and 1 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 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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 10 Nov 2010.