Skin Prick TestNCT01197274
Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Skin Prick Test Devices Among Mite-sensitized Subjects
An observational study of Skin Prick Test, run by Siriraj Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Prick Test
- What is being tested?
- Simple blood lancet
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at least)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pediatrics, Siriraj hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Devices for Skin Prick Test 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.
Read the 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.
- Conditions
- Skin Prick Test
- Being tested
- Simple blood lancet
- Keywords
- allergy, skin prick test, mite sensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple blood lancetDevice
Also called Vitrex®
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
| Study group | Role | What they receive |
|---|---|---|
| Mite-sensitized person | Not described Receives: Device: Simple blood lancet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Secondary outcomes (1)
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®)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Prick TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Professor Pakit Vichyanond, MD, Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197274
- Sponsor's protocol ID
- 186/2553(EC4)
- Status last verified
- Jun 2010
- First submitted
- 8 Sep 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Devices for Skin Prick Test Among Mite-sensitized Subjects
- ClinicalTrials.gov ID
- NCT01197274
- Acronym / sponsor ID
- 186/2553(EC4)
- Conditions
- Skin Prick Test
- Keywords
- allergy, skin prick test, mite sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mite-sensitized person | – | Device: Simple blood lancet |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at least)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple blood lancetAlso: Vitrex®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 | Device | Mite-sensitized person |
Primary outcome
Wheal and flare reaction to Der p results of skin prick test by simple blood lancet (Vitrex®)
Time frame: 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
1 secondary outcome
Determine transfer of allergen by simple blood lancet and Duotips.
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Pakit Vichyanond, MD study director
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Prick Test, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheal and flare reaction to Der p results of skin prick test by simple blood lancet (Vitrex®) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2010.