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

Immediate Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561429
• Other study ID #: si645/2012
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: May 2, 2016
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypersensitivity
• Hypersensitivity, Immediate
• Immediate Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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. — View Citation

Ménardo JL, Bousquet J, Rodière M, Astruc J, Michel FB. Skin test reactivity in infancy. J Allergy Clin Immunol. 1985 Jun;75(6):646-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean wheal diameters of SPT of different histamine concentrations.	compare mean wheal diameters of histamine concentration 1,5, and 10 mg/ml	1 years	Yes
Secondary	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	1 year	Yes