NCT03489694

Repeatability and Reproducibility of Skin Test Endpoint Titration

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Reaction

Interventions

Type	Name	Description
PROCEDURE	Skin 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.

Timeline

• Start date: 2018-05-04
• Primary completion: 2018-07-25
• Completion: 2018-07-25
• First posted: 2018-04-05
• Last updated: 2018-10-11

Locations

1 site across 1 country: Canada