Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-01 @ 6:37 AM
Study NCT ID:
NCT00640250
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2008-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+45 65 41 27 08', 'title': 'Evy Paulsen, MD', 'organization': 'Institute of Clinical Research, Department of Dermoto Venerology and Allergy Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were no limitations or caveats which led to unreadable or uninterpretable data.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Day 21', 'description': 'Serious or possibly related events were to be followed until they resolved or assessed as chronic or stable', 'eventGroups': [{'id': 'EG000', 'title': 'All Subjects', 'otherNumAtRisk': 48, 'otherNumAffected': 2, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upset stomach', 'notes': 'Event was not related to the investigational panel.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'notes': 'Event could not be attributed to a single allergen or allergen concentration. It was determined to be related to the the entire panel.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Performance: Optimal Test Allergen Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Disperse Blue 0.017 mg/cm2', 'description': 'Percentage of positive test responses'}, {'id': 'OG001', 'title': 'Disperse Blue 0.050 mg/cm2', 'description': 'Percentage of positive test responses'}, {'id': 'OG002', 'title': 'Disperse Blue 0.150 mg/cm2', 'description': 'Percentage of positive test responses'}, {'id': 'OG003', 'title': 'Bronopol 0.125 mg/cm2', 'description': 'Percentage of positive test responses'}, {'id': 'OG004', 'title': 'Bronopol 0.250 mg/cm2', 'description': 'Percentage of positive test responses'}, {'id': 'OG005', 'title': 'Bronopol 0.500 mg/cm2', 'description': 'Percentage of positive test responses'}, {'id': 'OG006', 'title': 'Bronopol 0.750 mg/cm2', 'description': 'Percentage of positive test responses'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}, {'value': '47.6', 'groupId': 'OG001'}, {'value': '52.4', 'groupId': 'OG002'}, {'value': '30.8', 'groupId': 'OG003'}, {'value': '23.1', 'groupId': 'OG004'}, {'value': '46.2', 'groupId': 'OG005'}, {'value': '61.5', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visits 3-5: 3-21 days after application', 'description': 'Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage is based on subjects sensitive to each allergen. Results from one subject not included due to no past history of positive patch test.'}, {'type': 'PRIMARY', 'title': 'Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}, {'value': '48', 'groupId': 'OG009'}, {'value': '48', 'groupId': 'OG010'}, {'value': '48', 'groupId': 'OG011'}, {'value': '48', 'groupId': 'OG012'}, {'value': '48', 'groupId': 'OG013'}, {'value': '48', 'groupId': 'OG014'}, {'value': '48', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Disperse Blue 0.017 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who 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'OG007', 'title': 'Negative Control Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 3'}, {'id': 'OG008', 'title': 'Disperse Blue 0.017 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG009', 'title': 'Disperse Blue 0.050 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG010', 'title': 'Disperse Blue 0.150 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG011', 'title': 'Negative Control Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG012', 'title': 'Disperse Blue 0.017 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}, {'id': 'OG013', 'title': 'Disperse Blue 0.050 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}, {'id': 'OG014', 'title': 'Disperse Blue 0.150 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}, {'id': 'OG015', 'title': 'Negative Control Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '30.2'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '32.6'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '39.6'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '11.1'}, {'value': '75.0', 'groupId': 'OG004', 'lowerLimit': '60.4', 'upperLimit': '86.4'}, {'value': '77.1', 'groupId': 'OG005', 'lowerLimit': '62.7', 'upperLimit': '88.0'}, {'value': '72.9', 'groupId': 'OG006', 'lowerLimit': 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'Disperse Blue 0.017 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG001', 'title': 'Disperse Blue 0.050 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG002', 'title': 'Disperse Blue 0.150 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG003', 'title': 'Negative Control Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG004', 'title': 'Disperse Blue 0.017 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG005', 'title': 'Disperse Blue 0.050 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG006', 'title': 'Disperse Blue 0.150 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG007', 'title': 'Negative Control Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG008', 'title': 'Disperse Blue 0.017 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG009', 'title': 'Disperse Blue 0.050 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG010', 'title': 'Disperse Blue 0.150 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG011', 'title': 'Negative Control Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG012', 'title': 'Disperse Blue 0.017 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}, {'id': 'OG013', 'title': 'Disperse Blue 0.050 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}, {'id': 'OG014', 'title': 'Disperse Blue 0.150 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}, {'id': 'OG015', 'title': 'Negative Control Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '32.6'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '32.6'}, {'value': '27.1', 'groupId': 'OG002', 'lowerLimit': '15.3', 'upperLimit': '41.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '75.0', 'groupId': 'OG004', 'lowerLimit': '60.4', 'upperLimit': '86.4'}, {'value': '72.9', 'groupId': 'OG005', 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subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '47', 'groupId': 'OG009'}, {'value': '47', 'groupId': 'OG010'}, {'value': '47', 'groupId': 'OG011'}, {'value': '47', 'groupId': 'OG012'}, {'value': '47', 'groupId': 'OG013'}, {'value': '47', 'groupId': 'OG014'}, {'value': '47', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Bronopol 0.1 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 3'}, {'id': 'OG001', 'title': 'Bronopol 0.250 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 3'}, {'id': 'OG002', 'title': 'Bronopol 0.500 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 3'}, {'id': 'OG003', 'title': 'Bronopol 0.750 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 3'}, {'id': 'OG004', 'title': 'Bronopol 0.1 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 3'}, {'id': 'OG005', 'title': 'Bronopol 0.250 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 3'}, {'id': 'OG006', 'title': 'Bronopol 0.500 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 3'}, {'id': 'OG007', 'title': 'Bronopol 0.750 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 3'}, {'id': 'OG008', 'title': 'Bronopol 0.1 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG009', 'title': 'Bronopol 0.250 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG010', 'title': 'Bronopol 0.500 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG011', 'title': 'Bronopol 0.750 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 3'}, {'id': 'OG012', 'title': 'Bronopol 0.1 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}, {'id': 'OG013', 'title': 'Bronopol 0.250 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}, {'id': 'OG014', 'title': 'Bronopol 0.500 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}, {'id': 'OG015', 'title': 'Bronopol 0.750 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 3'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '27.8'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '27.8'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '39.6'}, {'value': '45.8', 'groupId': 'OG003', 'lowerLimit': '31.4', 'upperLimit': '60.8'}, {'value': '79.2', 'groupId': 'OG004', 'lowerLimit': '65.0', 'upperLimit': '89.5'}, {'value': '72.9', 'groupId': 'OG005', 'lowerLimit': '58.2', 'upperLimit': '84.7'}, {'value': '58.3', 'groupId': 'OG006', 'lowerLimit': '43.2', 'upperLimit': '72.4'}, {'value': '37.5', 'groupId': 'OG007', 'lowerLimit': '24.0', 'upperLimit': '52.6'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '2.1', 'groupId': 'OG010', 'lowerLimit': '0.1', 'upperLimit': '11.1'}, {'value': '0.0', 'groupId': 'OG011', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '6.3', 'groupId': 'OG012', 'lowerLimit': '1.3', 'upperLimit': '17.2'}, {'value': '12.5', 'groupId': 'OG013', 'lowerLimit': '4.7', 'upperLimit': '25.2'}, {'value': '14.6', 'groupId': 'OG014', 'lowerLimit': '6.1', 'upperLimit': '27.8'}, {'value': '16.7', 'groupId': 'OG015', 'lowerLimit': '7.5', 'upperLimit': '30.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3 days after application', 'description': 'Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject not included because subject did not have a past positive response to either allergen.'}, {'type': 'PRIMARY', 'title': 'Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '47', 'groupId': 'OG009'}, {'value': '47', 'groupId': 'OG010'}, {'value': '47', 'groupId': 'OG011'}, {'value': '47', 'groupId': 'OG012'}, {'value': '47', 'groupId': 'OG013'}, {'value': '47', 'groupId': 'OG014'}, {'value': '47', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Bronopol 0.125 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG001', 'title': 'Bronopol 0.250 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG002', 'title': 'Bronopol 0.500 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG003', 'title': 'Bronopol 0.750 mg/cm2 Positive Reactions', 'description': 'Percentage of subjects who exhibited positive reactions at visit 4'}, {'id': 'OG004', 'title': 'Bronopol 0.125 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG005', 'title': 'Bronopol 0.250 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG006', 'title': 'Bronopol 0.500 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG007', 'title': 'Bronopol 0.750 mg/cm2 Negative Reactions', 'description': 'Percentage of subjects who exhibited negative reactions at visit 4'}, {'id': 'OG008', 'title': 'Bronopol 0.125 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG009', 'title': 'Bronopol 0.250 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG010', 'title': 'Bronopol 0.500 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG011', 'title': 'Bronopol 0.750 mg/cm2 Irritant Reactions', 'description': 'Percentage of subjects who exhibited irritant reactions at visit 4'}, {'id': 'OG012', 'title': 'Bronopol 0.125 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}, {'id': 'OG013', 'title': 'Bronopol 0.250 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}, {'id': 'OG014', 'title': 'Bronopol 0.500 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}, {'id': 'OG015', 'title': 'Bronopol 0.750 mg/cm2 Doubtful Reactions', 'description': 'Percentage of subjects who exhibited doubtful reactions at visit 4'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '28.3'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '30.8'}, {'value': '21.3', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '35.7'}, {'value': '29.8', 'groupId': 'OG003', 'lowerLimit': '17.3', 'upperLimit': '44.9'}, {'value': '78.7', 'groupId': 'OG004', 'lowerLimit': '64.3', 'upperLimit': '89.3'}, {'value': '74.5', 'groupId': 'OG005', 'lowerLimit': '59.7', 'upperLimit': '86.1'}, {'value': '59.6', 'groupId': 'OG006', 'lowerLimit': '44.3', 'upperLimit': '73.6'}, {'value': '57.4', 'groupId': 'OG007', 'lowerLimit': '42.2', 'upperLimit': '71.7'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '4.3', 'groupId': 'OG010', 'lowerLimit': '0.5', 'upperLimit': '14.5'}, {'value': '8.5', 'groupId': 'OG011', 'lowerLimit': '2.4', 'upperLimit': '20.4'}, {'value': '6.4', 'groupId': 'OG012', 'lowerLimit': '1.3', 'upperLimit': '17.5'}, {'value': '8.5', 'groupId': 'OG013', 'lowerLimit': '2.4', 'upperLimit': '20.4'}, {'value': '14.9', 'groupId': 'OG014', 'lowerLimit': '6.2', 'upperLimit': '28.3'}, {'value': '4.3', 'groupId': 'OG015', 'lowerLimit': '0.5', 'upperLimit': '14.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 4: 7 days after application', 'description': 'Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject not included because subject did not have past positive response to either allergen.'}, {'type': 'PRIMARY', 'title': 'Concordance Between Investigational Allergen and Reference Allergen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Disperse Blue 0.017 mg/cm2', 'description': 'Concordance between disperse blue and the reference petrolatum allergen'}, {'id': 'OG001', 'title': 'Disperse Blue 0.050 mg/cm2', 'description': 'Concordance between disperse blue and the reference petrolatum allergen'}, {'id': 'OG002', 'title': 'Disperse Blue 0.150 mg/cm2', 'description': 'Concordance between disperse blue and the reference petrolatum allergen'}, {'id': 'OG003', 'title': 'Bronopol 0.125 mg/cm2', 'description': 'Concordance between bronopol and the reference petrolatum allergen'}, {'id': 'OG004', 'title': 'Bronopol 0.250 mg/cm2', 'description': 'Concordance between bronopol and the reference petrolatum allergen'}, {'id': 'OG005', 'title': 'Bronopol 0.500 mg/cm2', 'description': 'Concordance between bronopol and the reference petrolatum allergen'}, {'id': 'OG006', 'title': 'Bronopol 0.750 mg/cm2', 'description': 'Concordance between bronopol and the reference petrolatum allergen'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '58.1', 'upperLimit': '94.6'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '99.9'}, {'value': '90.5', 'groupId': 'OG002', 'lowerLimit': '69.6', 'upperLimit': '98.8'}, {'value': '84.6', 'groupId': 'OG003', 'lowerLimit': '65.1', 'upperLimit': '95.6'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '86.8', 'upperLimit': '100.0'}, {'value': '76.9', 'groupId': 'OG005', 'lowerLimit': '56.4', 'upperLimit': '91.0'}, {'value': '61.5', 'groupId': 'OG006', 'lowerLimit': '40.6', 'upperLimit': '79.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 5: 21 days after patch application', 'description': 'Concordance between disperse blue or bronopol and the respective reference petrolatum allergen', 'unitOfMeasure': 'percentage of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject not included because subject did not have past positive response to either allergen.'}, {'type': 'SECONDARY', 'title': 'Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}, {'value': '21', 'groupId': 'OG009'}, {'value': '21', 'groupId': 'OG010'}, {'value': '21', 'groupId': 'OG011'}, {'value': '26', 'groupId': 'OG012'}, {'value': '26', 'groupId': 'OG013'}, {'value': '26', 'groupId': 'OG014'}, {'value': '26', 'groupId': 'OG015'}, {'value': '26', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '26', 'groupId': 'OG018'}, {'value': '26', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Disperse Blue Irritation Reactions', 'description': 'Percentage of subjects who exhibited irritation (tape reactions) to disperse blue panel'}, {'id': 'OG001', 'title': 'Bronopol Irritation Reactions', 'description': 'Percentage of subjects who exhibited irritation (tape reactions) to bronopol panel'}, {'id': 'OG002', 'title': 'Disperse Blue Itching and/or Burning', 'description': 'Percentage of subjects who exhibited itching and/or burning to disperse blue panel'}, {'id': 'OG003', 'title': 'Bronopol Itching and/or Burning', 'description': 'Percentage of subjects who exhibited itching and/or burning to bronopol panel'}, {'id': 'OG004', 'title': 'Disperse Blue 0.017 Late Reactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG005', 'title': 'Disperse Blue 0.050 mg/cm2 Late Reactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG006', 'title': 'Disperse Blue 0.150 mg/cm2 Late Reactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG007', 'title': 'Negative Control Late Reactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG008', 'title': 'Disperse Blue 0.017 mg/cm2 Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}, {'id': 'OG009', 'title': 'Disperse Blue 0.050 mg/cm2 Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}, {'id': 'OG010', 'title': 'Disperse Blue 0.150 mg/cm2 Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}, {'id': 'OG011', 'title': 'Negative Control Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}, {'id': 'OG012', 'title': 'Bronopol 0.125 mg/cm2 Late Reactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG013', 'title': 'Bronopol 0.250 mg/cm2 Late Reactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG014', 'title': 'Bronopol 0.500 mg/cm2 Late Reactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG015', 'title': 'Bronopol 0.750 mg/cm2 LateReactions', 'description': 'Percentage of subjects who exhibited late reactions'}, {'id': 'OG016', 'title': 'Bronopol 0.125 mg/cm2 Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}, {'id': 'OG017', 'title': 'Bronopol 0.250 mg/cm2 Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}, {'id': 'OG018', 'title': 'Bronopol 0.500 mg/cm2 Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}, {'id': 'OG019', 'title': 'Bronopol 0.750 mg/cm2 Persistent Reactions', 'description': 'Percentage of subjects who exhibited persistent reactions'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '65.4', 'groupId': 'OG001'}, {'value': '76.2', 'groupId': 'OG002'}, {'value': '73.1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '19.0', 'groupId': 'OG008'}, {'value': '19.0', 'groupId': 'OG009'}, {'value': '28.6', 'groupId': 'OG010'}, {'value': '1.9', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '11.5', 'groupId': 'OG016'}, {'value': '15.4', 'groupId': 'OG017'}, {'value': '11.5', 'groupId': 'OG018'}, {'value': '11.5', 'groupId': 'OG019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2-21', 'description': 'Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions.\n\nLate reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject not included because subject did not have past positive response to either allergen.'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adverse Events Related to Investigational Panel', 'description': 'Number of reported adverse events related to investigational or reference allergens.'}, {'id': 'OG001', 'title': 'Adverse Events Not Related', 'description': 'Number of adverse events not related to investigational or reference allergens'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0-21', 'description': 'The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sensitives', 'description': 'Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Dates of recruitment: 16 June 2008 through 7 April 2009. This study was conducted at two investigational sites located in Denmark (E Paulsen) and the United States (J Fowler).', 'preAssignmentDetails': 'There were no significant events or approaches which caused enrolled participants to be excluded from the trial before assignment to a group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sensitives', 'description': 'Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '14.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The analysis included all enrolled subjects but it should be noted that subject 5-D220 was not sensitive to either allergen and thus was not included in either population of sensitive subjects; the subject was included in the population of all enrolled subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-06', 'studyFirstSubmitDate': '2008-03-03', 'resultsFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-06', 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Performance: Optimal Test Allergen Concentration', 'timeFrame': 'Visits 3-5: 3-21 days after application', 'description': 'Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects'}, {'measure': 'Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration', 'timeFrame': 'Visit 3: 3 days after application', 'description': 'Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects'}, {'measure': 'Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration', 'timeFrame': 'Visit 4: 7 days after application', 'description': 'Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects'}, {'measure': 'Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration', 'timeFrame': 'Visit 3: 3 days after application', 'description': 'Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects'}, {'measure': 'Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration', 'timeFrame': 'Visit 4: 7 days after application', 'description': 'Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects'}, {'measure': 'Concordance Between Investigational Allergen and Reference Allergen', 'timeFrame': 'Visit 5: 21 days after patch application', 'description': 'Concordance between disperse blue or bronopol and the respective reference petrolatum allergen'}], 'secondaryOutcomes': [{'measure': 'Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning', 'timeFrame': 'Day 2-21', 'description': 'Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions.\n\nLate reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application'}, {'measure': 'Adverse Events', 'timeFrame': 'Days 0-21', 'description': 'The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermatitis, Contact, Bronopol, Disperse Blue 106'], 'conditions': ['Contact Dermatitis']}, 'descriptionModule': {'briefSummary': 'We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").', 'detailedDescription': 'Primary endpoint:\n\nTo evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:\n\n* Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.\n* Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.\n* Concordance/discordance as compared to the corresponding reference petrolatum allergen.\n\nSecondary endpoint:\n\nTo evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:\n\n* The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning.\n* The frequency and characterization of adverse events and serious adverse events.\n* The frequency and characterization of late and/or persistent reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix.\n* All subjects must be adults (18 years of age or older) and otherwise in good health.\n* Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.\n* Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.\n\nExclusion Criteria:\n\n* Subjects unable to meet inclusion requirements.\n* Women who are breastfeeding or pregnant.\n* Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.\n* Systemic treatment during the last 7 days with corticosteroids (equivalent to \\> 10 mg prednisone) or other immunosuppressive agents.\n* Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.\n* Acute dermatitis outbreak or dermatitis on or near the test area on the back.\n* Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).\n* Subject participation in clinical trials of investigational drugs, treatments or devices other than T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.'}, 'identificationModule': {'nctId': 'NCT00640250', 'briefTitle': 'Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allerderm'}, 'officialTitle': 'Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study', 'orgStudyIdInfo': {'id': 'Mekos 07 2P3.2 201'}, 'secondaryIdInfos': [{'id': '2007-007130-19', 'type': 'EUDRACT_NUMBER'}, {'id': 'WIRB Pr. No.: 20072233', 'type': 'OTHER', 'domain': 'Western Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensitives', 'description': 'Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.', 'interventionNames': ['Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens']}], 'interventions': [{'name': 'T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens', 'type': 'BIOLOGICAL', 'otherNames': ['T.R.U.E. TEST® Skin Patch Test: Panel 3.2'], 'description': 'Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2\n\nTest patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.', 'armGroupLabels': ['Sensitives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202-1864', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Dermatology Specialists PSC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': 'DK-5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'overallOfficials': [{'name': 'Evy Paulsen, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Joseph Fowler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Specialists PSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allerderm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}