Allergic ReactionNCT03489694
Repeatability and Reproducibility of Skin Test Endpoint Titration
An observational study of Allergic Reaction, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This study will examine the within-tester repeatability and between-tester reproducibility of skin test endpoint titrations performed in those with allergic sensitivities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic Reaction
- What is being tested?
- Skin test endpoint titration
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2018to 25 Jul 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the local community.
Who may be able to join
- must have allergic sensitivities confirmed by a skin prick test (or historically) to at least one of the study allergens
Who cannot join
- skin condition on the forearms
- if there is a situation where interpretation of skin reactions would be difficult (e.g. sleeve tattoos, scarring)
- regular use of anti-histamines (assessed on a case-by-case basis)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Within-tester Repeatability and Between-tester Reproducibility of Skin Test Endpoint Titration
This study will examine the within-tester repeatability and between-tester reproducibility of skin test endpoint titrations performed in those with allergic sensitivities.
Read the detailed description
Participants will be recruited from the local community. Participants with a previous history of skin prick testing in our lab will not be required to undergo preliminary skin prick testing, as the allergen to be used for skin prick titrations is known. New participants will undergo skin prick testing. The procedures for skin prick testing and skin test endpoint (STE) titration will be guided by the AllerGen CIC Allergen Skin Titration by Epicutaneous Method (Prick) Standard Operating Procedure. Different allergen extracts for the skin prick test or different doubling doses of an allergen in duplicate for the STE will be applied to the forearm, pricked with a lancet, and assessed ten minutes later by measuring the wheal sizes produced. The study will require three visits to the lab (i.e. three testers), each separated by one week and lasting roughly 30 minutes. Each visit will entail the duplicate STE procedure performed by a different tester. If a participant is new to the lab, they will undergo skin prick testing during their first lab visit prior to undergoing the skin prick titration and so, their first study visit may last up to one hour.
- Conditions
- Allergic Reaction
- Being tested
- Skin test endpoint titration
- Keywords
- skin test endpoint
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin test endpoint titrationProcedure or surgery
An allergen that is suitable to cause skin reactions when introduced to the forearm through pricking will be administered in doubling concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Each subject will undergo skin test endpoint titrations with three different testers. Receives: Procedure: Skin test endpoint titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-tester repeatability
Comparison of wheal size (in mm) of skin reactions caused by a tester (duplicate skin pricking for each concentration of allergen administered)
Measured: 10 minutes post skin pricking
Between-tester reproducibility
Comparison of wheal size (in mm) of skin reactions caused by three different testers
Measured: approximately 3 weeks (one week washout between tests)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start4 May 2018
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic ReactionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Dr. Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489694
- Sponsor's protocol ID
- STE-2018
- Status last verified
- Oct 2018
- First submitted
- 29 Mar 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blais CM, Davis BE, Cockcroft DW. Within-tester repeatability and between-tester reproducibility of skin test endpoint titration: A quality assurance study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):220-222. doi: 10.1016/j.anai.2018.10.009. Epub 2018 Oct 14. No abstract available.
PubMed 30326324
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Within-tester Repeatability and Between-tester Reproducibility of Skin Test Endpoint Titration
- ClinicalTrials.gov ID
- NCT03489694
- Acronym / sponsor ID
- STE-2018
- Conditions
- Allergic Reaction
- Keywords
- skin test endpoint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 5 Apr 2018 (actual)
- 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.
This study will examine the within-tester repeatability and between-tester reproducibility of skin test endpoint titrations performed in those with allergic sensitivities.
Detailed description
Participants will be recruited from the local community. Participants with a previous history of skin prick testing in our lab will not be required to undergo preliminary skin prick testing, as the allergen to be used for skin prick titrations is known. New participants will undergo skin prick testing. The procedures for skin prick testing and skin test endpoint (STE) titration will be guided by the AllerGen CIC Allergen Skin Titration by Epicutaneous Method (Prick) Standard Operating Procedure. Different allergen extracts for the skin prick test or different doubling doses of an allergen in duplicate for the STE will be applied to the forearm, pricked with a lancet, and assessed ten minutes later by measuring the wheal sizes produced. The study will require three visits to the lab (i.e. three testers), each separated by one week and lasting roughly 30 minutes. Each visit will entail the duplicate STE procedure performed by a different tester. If a participant is new to the lab, they will undergo skin prick testing during their first lab visit prior to undergoing the skin prick titration and so, their first study visit may last up to one hour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Procedure: Skin test endpoint titrationEach subject will undergo skin test endpoint titrations with three different testers. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the local community.
Key inclusion criteria (1 listed)
- must have allergic sensitivities confirmed by a skin prick test (or historically) to at least one of the study allergens
Key exclusion criteria (3 listed)
- skin condition on the forearms
- if there is a situation where interpretation of skin reactions would be difficult (e.g. sleeve tattoos, scarring)
- regular use of anti-histamines (assessed on a case-by-case basis)
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 |
|---|---|---|
| Skin test endpoint titrationAn allergen that is suitable to cause skin reactions when introduced to the forearm through pricking will be administered in doubling concentrations. | Procedure or surgery | Subjects |
Primary outcome
Within-tester repeatability
Time frame: 10 minutes post skin pricking
Comparison of wheal size (in mm) of skin reactions caused by a tester (duplicate skin pricking for each concentration of allergen administered)
Between-tester reproducibility
Time frame: approximately 3 weeks (one week washout between tests)
Comparison of wheal size (in mm) of skin reactions caused by three different testers
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 11 Oct 2018.
- Derived from this study: PubMed 30326324Blais CM, Davis BE, Cockcroft DW. Within-tester repeatability and between-tester reproducibility of skin test endpoint titration: A quality assurance study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):220-222. doi: 10.1016/j.anai.2018.10.009. Epub 2018 Oct 14. No abstract available.
- Individual participant dataSharing planned: No
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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.
Dr. Don Cockcroft, MD principal investigator
University of Saskatchewan
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 Allergic Reaction, run by University of Saskatchewan at 1 site in Canada.
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 1 inclusion and 3 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 11 Oct 2018. 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 Canada. 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?
Within-tester repeatability (time frame: 10 minutes post skin pricking). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489694, which also lists 1 linked publication.
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 11 Oct 2018.