NormalPhase 1NCT01156038
Atopy Patch Test in Normal Population : Pilot Study
A Phase 1 study testing Atopy patch test with food allergen in people with Normal, run by Mahidol University at 1 site in Thailand.
Trial summary
Atopy patch test in normal population Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal
- What is being tested?
- Atopy patch test with food allergen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2010to May 2010
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Age 18-40 yrs
- Volunteer sign for informed consent
Who cannot join
- who have dermographism
- who have chronic disease eg.autoimmune disease, immune deficiency, cancer or allergic disease
- pregnant women
- who have severe eczema
- who receive antihistamine, topical steroid and systemic steroid > 20 mg/day within 7 days prior study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pediatrics, Siriraj hospital, Mahidol University
Bangkok, 10700
About this study
Atopy patch test in normal population
Read the detailed description
The initial diagnostic work up of suspected food allergy includes patient's history, skin prick test (SPT), measurement of food specific immunoglobulin E (IgE) with serological assays, and more recently the atopy patch test. A positive SPT seems to reflect early reactions to food challenges, whereas the atopy patch test has a high diagnostic efficacy for late phase clinical reactions. The purpose of this study was to evaluate atopy patch test reaction in non-atopic population.
- Conditions
- Normal
- Being tested
- Atopy patch test with food allergen
- Keywords
- Atopy patch test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atopy patch test with food allergenDevice
Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate reaction one day later(72 hrs after applying atopy patch test)
| Study group | Role | What they receive |
|---|---|---|
| Atopy patch test | Experimental | Atopy patches were applied on healthy volunteer's back for 48 hrs then the patches were removed. Reaction was evaluated 48 and 72 hrs after applying atopy patch test Receives: Device: Atopy patch test with food allergen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction of atopy patch test
To evaluate outcome of atopy patch test reaction in non-atopic subject
Measured: 3 days
Secondary outcomes (1)
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen
To compare outcome of atopy patch test reaction using lyophilized allergen and commercial allergen
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormalStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Nualanong Visitsunthorn, Professor, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156038
- Sponsor's protocol ID
- 599/2552(EC4)
- Status last verified
- Jul 2010
- First submitted
- 16 May 2010
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atopy Patch Test in Normal Population : Pilot Study
- ClinicalTrials.gov ID
- NCT01156038
- Acronym / sponsor ID
- 599/2552(EC4)
- Conditions
- Normal
- Keywords
- Atopy patch test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Jul 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.
Atopy patch test in normal population
Detailed description
The initial diagnostic work up of suspected food allergy includes patient's history, skin prick test (SPT), measurement of food specific immunoglobulin E (IgE) with serological assays, and more recently the atopy patch test. A positive SPT seems to reflect early reactions to food challenges, whereas the atopy patch test has a high diagnostic efficacy for late phase clinical reactions. The purpose of this study was to evaluate atopy patch test reaction in non-atopic population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopy patch test | Experimental | Device: Atopy patch test with food allergenAtopy patches were applied on healthy volunteer's back for 48 hrs then the patches were removed. Reaction was evaluated 48 and 72 hrs after applying atopy patch test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteer
- Age 18-40 yrs
- Volunteer sign for informed consent
Key exclusion criteria (5 listed)
- who have dermographism
- who have chronic disease eg.autoimmune disease, immune deficiency, cancer or allergic disease
- pregnant women
- who have severe eczema
- 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 |
|---|---|---|
| Atopy patch test with food allergenAtopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate reaction one day later(72 hrs after applying atopy patch test) | Device | Atopy patch test |
Primary outcome
Reaction of atopy patch test
Time frame: 3 days
To evaluate outcome of atopy patch test reaction in non-atopic subject
1 secondary outcome
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen
Time frame: 3 days
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 Jul 2010.
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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.
Nualanong Visitsunthorn, Professor study director
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atopy patch test with food allergen in people with Normal, run by Mahidol University at 1 site in Thailand.
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 5 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 Jul 2010. 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 Thailand. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reaction of atopy patch test (time frame: 3 days). 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 2 Jul 2010.