Repeatability and Reproducibility of Skin Test Endpoint Titration

Allergic Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489694
• Other study ID #: STE-2018
• Status: Completed
• Start date: May 4, 2018
• Est. completion date: July 25, 2018

Study information

• Verified date: October 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 25, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Allergic Reaction
• Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Canada	Asthma Research Lab - University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	10 minutes post skin pricking
Primary	Between-tester reproducibility	Comparison of wheal size (in mm) of skin reactions caused by three different testers	approximately 3 weeks (one week washout between tests)