NCT02561429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

September 15, 2015

Last Update Submit

May 2, 2016

Conditions

Immediate Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Mean wheal diameters of SPT of different histamine concentrations.

    compare mean wheal diameters of histamine concentration 1,5, and 10 mg/ml

    1 years

Secondary Outcomes (1)

  • Mean wheal diameters of SPT of local and imported histamine positive concentration

    1 year

Study Arms (1)

SPT of histamine

EXPERIMENTAL

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

Procedure: SPT

Interventions

SPTPROCEDURE

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

SPT of histamine

Eligibility Criteria

Age7 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parcitipate person who attented allergy clinic, ENT clinic
  • Legible in Thai language

You may not qualify if:

  • Patient cannot withhold antihistamine drug
  • Pragnancy and lactation mother
  • comorbid disease such as cardiac disease, liver, renal, hypertension and severe asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 2409121BACKGROUND

  • 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.

    PMID: 1460201RESULT

MeSH Terms

Conditions

Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

HypersensitivityImmune System Diseases

Study Officials

  • Nualanong Visitsunthorn, Prof

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 28, 2015

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

TH(1)