Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT03489694
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2018-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeatability and Reproducibility of Skin Test Endpoint Titration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015927', 'term': 'Skin Test End-Point Titration'}], 'ancestors': [{'id': 'D007428', 'term': 'Intradermal Tests'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-03-29', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Within-tester repeatability', 'timeFrame': '10 minutes post skin pricking', 'description': 'Comparison of wheal size (in mm) of skin reactions caused by a tester (duplicate skin pricking for each concentration of allergen administered)'}, {'measure': 'Between-tester reproducibility', 'timeFrame': 'approximately 3 weeks (one week washout between tests)', 'description': 'Comparison of wheal size (in mm) of skin reactions caused by three different testers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skin test endpoint'], 'conditions': ['Allergic Reaction']}, 'referencesModule': {'references': [{'pmid': '30326324', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the within-tester repeatability and between-tester reproducibility of skin test endpoint titrations performed in those with allergic sensitivities.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from the local community.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must have allergic sensitivities confirmed by a skin prick test (or historically) to at least one of the study allergens\n\nExclusion Criteria:\n\n* skin condition on the forearms\n* if there is a situation where interpretation of skin reactions would be difficult (e.g. sleeve tattoos, scarring)\n* regular use of anti-histamines (assessed on a case-by-case basis)'}, 'identificationModule': {'nctId': 'NCT03489694', 'briefTitle': 'Repeatability and Reproducibility of Skin Test Endpoint Titration', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Within-tester Repeatability and Between-tester Reproducibility of Skin Test Endpoint Titration', 'orgStudyIdInfo': {'id': 'STE-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects', 'description': 'Each subject will undergo skin test endpoint titrations with three different testers.', 'interventionNames': ['Procedure: Skin test endpoint titration']}], 'interventions': [{'name': 'Skin test endpoint titration', 'type': 'PROCEDURE', 'description': 'An allergen that is suitable to cause skin reactions when introduced to the forearm through pricking will be administered in doubling concentrations.', 'armGroupLabels': ['Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Asthma Research Lab - University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Dr. Don Cockcroft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, College of Medicine', 'investigatorFullName': 'Don Cockcroft', 'investigatorAffiliation': 'University of Saskatchewan'}}}}