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Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control

Primary Purpose

Immediate Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
SPT
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Immediate Hypersensitivity

Eligibility Criteria

7 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPT of histamine

Arm Description

SPT of histamine concentration 1, 5 and 10 mg/ml

Outcomes

Primary Outcome Measures

Mean wheal diameters of SPT of different histamine concentrations.
compare mean wheal diameters of histamine concentration 1,5, and 10 mg/ml

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2015
Last Updated
May 2, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02561429
Brief Title
Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control
Official Title
Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Positive Control of Skin Prick Test
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immediate Hypersensitivity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPT of histamine
Arm Type
Experimental
Arm Description
SPT of histamine concentration 1, 5 and 10 mg/ml
Intervention Type
Procedure
Intervention Name(s)
SPT
Intervention Description
SPT of histamine concentration 1, 5 and 10 mg/ml
Primary Outcome Measure Information:
Title
Mean wheal diameters of SPT of different histamine concentrations.
Description
compare mean wheal diameters of histamine concentration 1,5, and 10 mg/ml
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Mean wheal diameters of SPT of local and imported histamine positive concentration
Description
compare mean wheal diameters of imported histamine 1 mg/ml to local histamine
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nualanong Visitsunthorn, Prof
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
2409121
Citation
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.
Results Reference
background
PubMed Identifier
1460201
Citation
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.
Results Reference
result

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Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control

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