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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01197274
Enrollment
42
Registered
2010-09-09
Start date
2010-06-30
Completion date
2010-08-31
Last updated
2010-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Prick Test

Keywords

allergy, skin prick test, mite sensitivity

Brief summary

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

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.

Interventions

DEVICESimple 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

Sponsors

Siriraj Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Wheal and flare reaction to Der p results of skin prick test by simple blood lancet (Vitrex®)15 minutesTo 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

MeasureTime frameDescription
Determine transfer of allergen by simple blood lancet and Duotips.15 minutesTo 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®)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026