Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-04 @ 10:43 PM
Study NCT ID:
NCT03509766
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2013-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012882', 'term': 'Skin Tests'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jodytversky@jhmi.edu', 'phone': '410-550-5949', 'title': 'Jody Tversky', 'organization': 'Johns Hopkins School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Adverse Events', 'description': 'no adverse events or reactions were reported. Events were recorded during the procedure and for 30 days following the procedure. Both serious and and non life threatening adverse vents were recorded.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wheal Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Skin Testing', 'description': 'All subjects both allergic and non-allergic will be tested. There is only one (1) arm.\n\nHistamine skin testing: skin testing using histamine'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Compare Wheal response among devices using 1mm precision. SPT test will be read at 15 min time point. The maximum wheal diameter will be recorded for each of ten skin prick devices. 3mm (and 2mm above negative control) qualify as a positive test.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Skin Testing', 'description': 'All subjects both allergic and non-allergic will be tested. There is only one (1) arm.\n\nHistamine skin testing: skin testing using histamine'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes', 'description': 'Sensitivity is calculated by dividing the true positive wheals divided by true positives plus false negatives and multiplying by 100. For example one false negative out of 24 tests equals a sensitivity of 95.8%.', 'unitOfMeasure': 'percentage of tests true positive', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Prick Techniques/Methodology Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1 Versus 6mg', 'description': '1 versus 6mg histamine'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 24 subjects received DuoTip II with both 1mg/ml and 6mg/ml histamine. This 24 vs 24 SPT in 24 total subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Skin Testing', 'description': 'All subjects both allergic and non-allergic will be tested. There is only one (1) arm.\n\nHistamine skin testing: skin testing using histamine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Skin Testing', 'description': 'All subject both allergic and non-allergic will be tested. There is only one (1) arm.\n\nHistamine skin testing: skin testing using histamine'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Neither the subject nor the technician are masked as to which device is being placed. However, the investigator who reads the skin prick test results is blinded as to which device is which.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2013-12-27', 'resultsFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-14', 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wheal Response', 'timeFrame': '15 minutes', 'description': 'Compare Wheal response among devices using 1mm precision. SPT test will be read at 15 min time point. The maximum wheal diameter will be recorded for each of ten skin prick devices. 3mm (and 2mm above negative control) qualify as a positive test.'}, {'measure': 'Sensitivity', 'timeFrame': '15 minutes', 'description': 'Sensitivity is calculated by dividing the true positive wheals divided by true positives plus false negatives and multiplying by 100. For example one false negative out of 24 tests equals a sensitivity of 95.8%.'}], 'secondaryOutcomes': [{'measure': 'Skin Prick Techniques/Methodology Ratio', 'timeFrame': '15 minutes', 'description': 'Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['allergic', 'rhinitis', 'allergy', 'asthma', 'food allergy', 'skin testing', 'skin prick test'], 'conditions': ['Allergic Rhinitis', 'Asthma', 'Food Allergy', 'Skin Testing']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare ten current and readily available FDA approved allergy skin prick devices to determine the most sensitive and specific product and methods used for the diagnosis of allergic disease. The primary outcome will be to determine the analytical sensitivity and specificity of all ten skin prick devices by measuring wheal and flare response to histamine and control diluent in 1mm increments. Secondary outcomes include comparison of skin prick technique, optimum histamine concentration, patient comfort, reproducibility, and the comparability of high-resolution digital images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-65 with or without allergic disease\n\nExclusion Criteria:\n\n* severe concurrent illness\n* uncontrolled asthma\n* extensive eczema\n* urticaria\n* dermatographism\n* pregnancy\n* those taking antihistamines within the previous 10 days\n* topical steroids\n* immunomodulatory drugs\n* long term use of oral steroids'}, 'identificationModule': {'nctId': 'NCT03509766', 'briefTitle': 'Randomized Evaluation of Ten Allergy Skin Prick Test Devices', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Randomized Evaluation of Ten Allergy Skin Prick Test Devices', 'orgStudyIdInfo': {'id': 'NA_00092406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin testing', 'description': 'All subject both allergic and non-allergic will be tested. There is only one (1) arm.', 'interventionNames': ['Device: Histamine skin testing']}], 'interventions': [{'name': 'Histamine skin testing', 'type': 'DEVICE', 'otherNames': ['skin test device', 'skin prick test device'], 'description': 'skin testing using histamine', 'armGroupLabels': ['Skin testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins Asthma and Allergy Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}