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

Completed

• Conditions: Skin Prick Test
• Interventions: Device: Simple blood lancet

• Registration Number: NCT01197274
• Lead Sponsor: Siriraj Hospital

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.

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Last Update Submitted: 2010-09-08
• Study First Posted: 2010-09-09
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mite-sensitized person	Simple blood lancet	-

Primary Outcome Measures

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

Name	Time	Method
Determine transfer of allergen by simple blood lancet and Duotips.	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®)

Trial Locations

Locations (1)

Department of Pediatrics, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand