Repeatability and Reproducibility of Skin Test Endpoint Titration
Within-tester Repeatability and Between-tester Reproducibility of Skin Test Endpoint Titration
1 other identifier
observational
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedStudy Start
First participant enrolled
May 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2018
CompletedOctober 11, 2018
October 1, 2018
3 months
March 29, 2018
October 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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)
Study Arms (1)
Subjects
Each subject will undergo skin test endpoint titrations with three different testers.
Interventions
An allergen that is suitable to cause skin reactions when introduced to the forearm through pricking will be administered in doubling concentrations.
Eligibility Criteria
Participants will be recruited from the local community.
You may qualify if:
- must have allergic sensitivities confirmed by a skin prick test (or historically) to at least one of the study allergens
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (1)
Blais CM, Davis BE, Cockcroft DW. Within-tester repeatability and between-tester reproducibility of skin test endpoint titration: A quality assurance study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):220-222. doi: 10.1016/j.anai.2018.10.009. Epub 2018 Oct 14. No abstract available.
PMID: 30326324DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Don Cockcroft, MD
University of Saskatchewan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, College of Medicine
Study Record Dates
First Submitted
March 29, 2018
First Posted
April 5, 2018
Study Start
May 4, 2018
Primary Completion
July 25, 2018
Study Completion
July 25, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share