Immediate HypersensitivityNCT02561429
Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control
A study testing SPT in people with Immediate Hypersensitivity, run by Mahidol University at 1 site in Thailand.
Trial summary
Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy and safety of SPT were proved. The positive control of SPT is histamine. In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some practice they use other concentration (1, 2.5 mg/ml). Read more about this study
- Who is it for?
- Ages 7 to 60 years
- Conditions the study is for
- Immediate Hypersensitivity
- What is being tested?
- SPT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2013to Aug 2015
- Phase
- Interventional
- 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 7 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parcitipate person who attented allergy clinic, ENT clinic
- Legible in Thai language
Who cannot join
- Patient cannot withhold antihistamine drug
- Pragnancy and lactation mother
- comorbid disease such as cardiac disease, liver, renal, hypertension and severe asthma
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Positive Control of Skin Prick Test
Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy and safety of SPT were proved. The positive control of SPT is histamine.
In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some practice they use other concentration (1, 2.5 mg/ml).
This study will find the proper concentration of histamine for positive control use in SPT.
Read the detailed description
Appropriate concentration of histamine positive control is important in interpretation the result of skin prick test.
- Conditions
- Immediate Hypersensitivity
- Being tested
- SPT
- Medical subject headings
- Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPTProcedure or surgery
SPT of histamine concentration 1, 5 and 10 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| SPT of histamine | Experimental | SPT of histamine concentration 1, 5 and 10 mg/ml Receives: Procedure: SPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean wheal diameters of SPT of different histamine concentrations.
compare mean wheal diameters of histamine concentration 1,5, and 10 mg/ml
Measured: 1 years
Secondary outcomes (1)
Mean wheal diameters of SPT of local and imported histamine positive concentration
compare mean wheal diameters of imported histamine 1 mg/ml to local histamine
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 posted28 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionAug 2015
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 Immediate HypersensitivityStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, Prof, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561429
- Sponsor's protocol ID
- si645/2012
- Status last verified
- May 2016
- First submitted
- 15 Sep 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Menardo JL, Bousquet J, Rodiere M, Astruc J, Michel FB. Skin test reactivity in infancy. J Allergy Clin Immunol. 1985 Jun;75(6):646-51. doi: 10.1016/0091-6749(85)90088-0.
PubMed 2409121Berkowitz RB, Tinkelman DG, Lutz C, Crummie A, Smith K. Evaluation of the Multi-Test device for immediate hypersensitivity skin testing. J Allergy Clin Immunol. 1992 Dec;90(6 Pt 1):979-85. doi: 10.1016/0091-6749(92)90471-d.
PubMed 1460201
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
- Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Positive Control of Skin Prick Test
- ClinicalTrials.gov ID
- NCT02561429
- Acronym / sponsor ID
- si645/2012
- Conditions
- Immediate Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 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.
Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy and safety of SPT were proved. The positive control of SPT is histamine.
In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some practice they use other concentration (1, 2.5 mg/ml).
This study will find the proper concentration of histamine for positive control use in SPT.
Detailed description
Appropriate concentration of histamine positive control is important in interpretation the result of skin prick test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPT of histamine | Experimental | Procedure: SPTSPT of histamine concentration 1, 5 and 10 mg/ml |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Parcitipate person who attented allergy clinic, ENT clinic
- Legible in Thai language
Key exclusion criteria (3 listed)
- Patient cannot withhold antihistamine drug
- Pragnancy and lactation mother
- comorbid disease such as cardiac disease, liver, renal, hypertension and severe asthma
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 |
|---|---|---|
| SPTSPT of histamine concentration 1, 5 and 10 mg/ml | Procedure or surgery | SPT of histamine |
Primary outcome
Mean wheal diameters of SPT of different histamine concentrations.
Time frame: 1 years
compare mean wheal diameters of histamine concentration 1,5, and 10 mg/ml
1 secondary outcome
Mean wheal diameters of SPT of local and imported histamine positive concentration
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.
- Background: PubMed 2409121Menardo JL, Bousquet J, Rodiere M, Astruc J, Michel FB. Skin test reactivity in infancy. J Allergy Clin Immunol. 1985 Jun;75(6):646-51. doi: 10.1016/0091-6749(85)90088-0.
- Results publication: PubMed 1460201Berkowitz RB, Tinkelman DG, Lutz C, Crummie A, Smith K. Evaluation of the Multi-Test device for immediate hypersensitivity skin testing. J Allergy Clin Immunol. 1992 Dec;90(6 Pt 1):979-85. doi: 10.1016/0091-6749(92)90471-d.
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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, Prof principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPT in people with Immediate Hypersensitivity, 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 2 inclusion and 3 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.
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.
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?
Mean wheal diameters of SPT of different histamine concentrations. (time frame: 1 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 NCT02561429, 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 3 May 2016.