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

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

Detailed Description
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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.

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

Conditions
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Skin Prick Test

Intervention / Treatment
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* Device: Simple blood lancet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mite-sensitized person<br> | Device: Simple blood lancet<br>* 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<br>* Other names: Vitrex®;|

What is the study measuring?
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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®) | 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 | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine transfer of allergen by simple blood lancet and Duotips. | 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®) | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergy, skin prick test, mite sensitivity