Repeatability and Reproducibility of Skin Test Endpoint Titration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-04

Study Completion Date

2018-07-25

Brief Summary

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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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Detailed Description

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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

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Allergic Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects

Each subject will undergo skin test endpoint titrations with three different testers.

Skin test endpoint titration

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No