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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197274
First Posted: September 9, 2010
Last Update Posted: September 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Siriraj Hospital
  Purpose
The purpose of this study is to compare the results skin prick tests using simple blood lancet (Vitrex®) with DuoTips among mite-sensitized subjects.

Condition Intervention Phase
Skin Prick Test Device: Simple blood lancet Phase 1 Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Devices for Skin Prick Test Among Mite-sensitized Subjects

Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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®)


Enrollment: 42
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Vitrex®

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197274


Locations
Thailand
Department of Pediatrics, Siriraj hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Investigators
Study Director: Professor Pakit Vichyanond, MD Siriraj Hospital
  More Information

Responsible Party: Professor Pakit Vichyanond, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01197274     History of Changes
Other Study ID Numbers: 186/2553(EC4)
First Submitted: September 8, 2010
First Posted: September 9, 2010
Last Update Posted: September 9, 2010
Last Verified: June 2010

Keywords provided by Siriraj Hospital:
allergy
skin prick test
mite sensitivity