Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Skin Prick Test Devices Among Mite-sensitized Subjects

September 8, 2010 updated by: Siriraj Hospital

Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Devices for Skin Prick Test Among Mite-sensitized Subjects

The purpose of this study is to compare the results skin prick tests using simple blood lancet (Vitrex®) with DuoTips among mite-sensitized subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We intend to compare results of skin prick tests by using simple blood lancet(Vitrex®) and DuoTips in terms of wheal size, variability, transfer of allergen and pain level, among mite-sensitive subjects.

Study Type

Observational

Enrollment (Actual)

42

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, Thailand, 10700
        • Department of Pediatrics, Siriraj hospital, Mahidol University

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

12 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at least)

Description

Inclusion Criteria:

  • Who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at least)
  • Age 12-60 yrs
  • Written informed consent was obtained from all subjects and their parents

Exclusion Criteria:

  • Who have positive skin prick testing to Der p 10,000 AU/ml above 15 mm.
  • Who have dermographism
  • Who have severe disease eg. severe respiratory disease or severe cardiovascular disease
  • Who have severe eczema
  • Who receive antihistamine, topical steroid within 7 days or ketotifen within 14 days or systemic steroid within 1 month
  • Pregnant women

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mite-sensitized person
Device: Simple blood lancet
Skin prick testing with blood lancet and DuoTip is performed on the back of mite-sensitized person. Allergen(Der p)is placed in 1st and 2nd row whereas histamine is placed in 3rd row. Allergen and normal saline are placed alternately in 4th row. Block randomization were allocated subjects into 2 groups; Group1:blood lancet is performed in 1st row and DuoTip in 2nd row. Group2:DuoTip is performed in 1st row and blood lancet in 2nd row. Blood lancet is applied in 3rd and 4th row in all subjects. A technician performed device applications and another technician who is blinded to device performed all readings. Pain was assessed on a scale from 0 to 10 with 0 being no pain and 10 being the worst imaginable pain
Other Names:
  • Vitrex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wheal and flare reaction to Der p results of skin prick test by simple blood lancet (Vitrex®)
Time Frame: 15 minutes

To determine

  1. Wheal and flare diameter to Der p performed by blood lancet(Vitrex®)compared with DuoTip in mite-sensitized person
  2. Intradevice variability or coefficients of variation of blood lancet compared wtih DuoTip
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine transfer of allergen by simple blood lancet and Duotips.
Time Frame: 15 minutes

To determine

  1. Transfer of allergen(Der p)performed by simple blood lancet(Vitrex®)
  2. Pain assessment by using visual analog scale
  3. Wheal and flare diameter to histamine performed by simple blood lancet(Vitrex®)
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Study Director: Professor Pakit Vichyanond, MD, Siriraj Hospital

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

June 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (ESTIMATE)

September 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2010

Last Update Submitted That Met QC Criteria

September 8, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 186/2553(EC4)

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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