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

NCT ID: NCT02561429

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-08-31

Brief Summary

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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

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Appropriate concentration of histamine positive control is important in interpretation the result of skin prick test.

Conditions

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Immediate Hypersensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SPT of histamine

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

Group Type EXPERIMENTAL

SPT

Intervention Type PROCEDURE

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

Interventions

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SPT

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Nualanong Visitsunthorn

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nualanong Visitsunthorn, Prof

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 2409121 (View on PubMed)

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.

Reference Type RESULT
PMID: 1460201 (View on PubMed)

Other Identifiers

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si645/2012

Identifier Type: -

Identifier Source: org_study_id

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