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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

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

NCT ID

NCT02561429

First Posted

September 15, 2015

Last Updated

May 2, 2016

Sponsor

Mahidol University

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

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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