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Completed

NCT Number: NCT01197274

Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Skin Prick Test Devices 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.

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Key information

Conditions

Skin Prick Test Hypersensitivity Immune System Diseases

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simple blood lancet

Device

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®

Primary outcomes

  1. Wheal and flare reaction to Der p results of skin prick test by simple blood lancet (Vitrex®)

    Time frame: 15 minutes

    To determine

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

Secondary outcomes

  1. Determine transfer of allergen by simple blood lancet and Duotips.

    Time frame: 15 minutes

    To determine

    • Transfer of allergen(Der p)performed by simple blood lancet(Vitrex®)
    • Pain assessment by using visual analog scale
    • Wheal and flare diameter to histamine performed by simple blood lancet(Vitrex®)

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2010
Registry last updated
Sep 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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