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Repeatability and Reproducibility of Skin Test Endpoint Titration

Within-tester Repeatability and Between-tester Reproducibility of Skin Test Endpoint Titration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03489694
Enrollment
17
Registered
2018-04-05
Start date
2018-05-04
Completion date
2018-07-25
Last updated
2018-10-11

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

Conditions

Allergic Reaction

Keywords

skin test endpoint

Brief summary

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.

Interventions

PROCEDURESkin test endpoint titration

An allergen that is suitable to cause skin reactions when introduced to the forearm through pricking will be administered in doubling concentrations.

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* must have allergic sensitivities confirmed by a skin prick test (or historically) to at least one of the study allergens

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Within-tester repeatability10 minutes post skin prickingComparison of wheal size (in mm) of skin reactions caused by a tester (duplicate skin pricking for each concentration of allergen administered)
Between-tester reproducibilityapproximately 3 weeks (one week washout between tests)Comparison of wheal size (in mm) of skin reactions caused by three different testers

Countries

Canada

Outcome results

None listed

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