Atopic DermatitisNCT02552979
Atopy Patch Test in Children With Atopic Dermatitis
An observational study of Atopic Dermatitis and Food Allergy, run by Mahidol University.
Trial summary
Positive reactions in atopy patch test in children with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Atopic Dermatitis, Food Allergy
- What is being tested?
- atopic patch test
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 2015
- 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 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with atopic dermatitis
Who may be able to join
- Patients who had history of atopic dermatitis
Who cannot join
- Who have dermographism
- Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease
- Pregnant women
- Who receive antihistamine, topical steroid and systemic steroid > 20 mg/day within 7 days prior study
About this study
Positive reactions in atopy patch test in children with atopic dermatitis.
Read the detailed description
The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate:
(i) The prevalence of positive reaction of APTs for atopic dermatitis (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse
- Conditions
- Atopic Dermatitis, Food Allergy
- Being tested
- atopic patch test
- Keywords
- atopic dermatitis, atopic patch test
- Medical subject headings
- Dermatitis, Atopic, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atopic patch testOther
What is being measured
The primary outcome is the main question the study is designed to answer.
atopic patch test in atopic dermatitis children
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552979
- Sponsor's protocol ID
- Si524/2011
- Status last verified
- May 2016
- First submitted
- 16 Sep 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atopy Patch Test in Children With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02552979
- Acronym / sponsor ID
- Si524/2011
- Conditions
- Atopic Dermatitis, Food Allergy
- Keywords
- atopic dermatitis, atopic patch test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Sep 2015 (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.
Positive reactions in atopy patch test in children with atopic dermatitis.
Detailed description
The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate:
(i) The prevalence of positive reaction of APTs for atopic dermatitis (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with atopic dermatitis
Key inclusion criteria (1 listed)
- Patients who had history of atopic dermatitis
Key exclusion criteria (4 listed)
- Who have dermographism
- Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease
- Pregnant women
- Who receive antihistamine, topical steroid and systemic steroid > 20 mg/day within 7 days prior study
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 |
|---|---|---|
| atopic patch test | Other | – |
Primary outcome
atopic patch test in atopic dermatitis children
Time frame: 1 year
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 3 May 2016.
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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.
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 and Food Allergy, run by Mahidol 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 4 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 3 May 2016. 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.
What does the primary outcome measure?
atopic patch test in atopic dermatitis children (time frame: 1 year). 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 3 May 2016.