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

Status

Completed

Conditions

Intervention / Treatment

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

  • Thailand
    • 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
Procedure: SPT
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

Mahidol University

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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