Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control
May 2, 2016 updated by: Nualanong Visitsunthorn, Mahidol University
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.
Study Overview
Detailed Description
Appropriate concentration of histamine positive control is important in interpretation the result of skin prick test.
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parcitipate person who attented allergy clinic, ENT clinic
- Legible in Thai language
Exclusion Criteria:
- Patient cannot withhold antihistamine drug
- Pragnancy and lactation mother
- comorbid disease such as cardiac disease, liver, renal, hypertension and severe asthma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SPT of histamine
SPT of histamine concentration 1, 5 and 10 mg/ml
|
SPT of histamine concentration 1, 5 and 10 mg/ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean wheal diameters of SPT of local and imported histamine positive concentration
Time Frame: 1 year
|
compare mean wheal diameters of imported histamine 1 mg/ml to local histamine
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nualanong Visitsunthorn, Prof, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Berkowitz 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 15, 2015
First Submitted That Met QC Criteria
September 25, 2015
First Posted (Estimate)
September 28, 2015
Study Record Updates
Last Update Posted (Estimate)
May 3, 2016
Last Update Submitted That Met QC Criteria
May 2, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- si645/2012
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