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Completed

NCT Number: NCT03489694

Repeatability and 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Skin test endpoint titration

Procedure

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

Primary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2018
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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