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

Skin Prick Test Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197274
• Other study ID #: 186/2553(EC4)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 8, 2010
• Last updated: September 8, 2010
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: June 2010
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Skin Prick Test

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Pediatrics, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes