Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-30 @ 3:09 AM
Study NCT ID:
NCT00795951
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2008-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Sponsor:
Organization:
Raw JSON
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Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Neomycin Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Wool Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Potassium Dichromate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. 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Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Fragrance Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Colophony', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Paraben Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Negative Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Balsam of Peru', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Ethylenediamine Dihydrochloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. 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Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Black Rubber Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Cl+Me-Isothiazolinone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Quaternium-15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Mercaptobenzothiazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: p-Phenylenediamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Formaldehyde', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Mercapto Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Thimerosal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Thiuram Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Diazolidinyl Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Imidazolidinyl Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Tixocortol-21-pivalate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Positive Reactions: Quinoline Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Late Reactions: Nickel Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. 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Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Balsam of Peru', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Ethylenediamine Dihydrochloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Cobalt Dichloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: P-tert Butylphenol Formadehyde Resin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Epoxy Resin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Carba Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Black Rubber Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Cl+Me-Isothiazolinone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Quaternium-15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: p-Phenylenediamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Formaldehyde', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Mercapto Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Thimerosal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Thiuram Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Diazolidinyl Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Imidazolidinyl Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Tixocortol-21-pivalate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Quinoline Mix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Persistent Reactions: Mercaptobenzothiazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes all subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Panel Adhesion Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'title': 'Panel 1 Adhesion Scores', 'categories': [{'title': 'Excellent', 'measurements': [{'value': '71', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Fair', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Fell off', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Panel 2 Adhesion Scores', 'categories': [{'title': 'Excellent', 'measurements': [{'value': '72', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Fair', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Fell off', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Panel 3 Adhesion Scores', 'categories': [{'title': 'Excellent', 'measurements': [{'value': '82', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Fair', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Fell off', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (day 1) prior to panel removal.', 'description': 'Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the study are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Panel Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'title': 'Panel 1 Irritation', 'categories': [{'title': 'None', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Weak', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Strong', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Panel 2 Irritation', 'categories': [{'title': 'None', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Weak', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Strong', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Panel 3 Irritation', 'categories': [{'title': 'None', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Weak', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Strong', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (day 1) following to panel removal.', 'description': 'Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the study are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subject Reported Itching and Burning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test allergen panel evaluations'}], 'classes': [{'title': 'Panel 1 Itching and Burning', 'categories': [{'title': 'None', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Weak', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Strong', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Panel 2 Itching and Burning', 'categories': [{'title': 'None', 'measurements': [{'value': '44', 'groupId': 'OG000'}]}, {'title': 'Weak', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Strong', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Panel 3 Itching and Burning', 'categories': [{'title': 'None', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}, {'title': 'Weak', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Strong', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (day 1) following to panel removal.', 'description': 'Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the study are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'T.R.U.E. Test Allergen Panel evaluations'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Single Site- Rady Children's Hospital Recruiting Period-09 December 2008 (first subject enrolled) 27 October 2009 (last subject exited)", 'preAssignmentDetails': 'No significant events or approaches'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Study', 'description': 'All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '3.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2008-11-20', 'resultsFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-19', 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Reactions: Nickel Sulfate', 'timeFrame': 'Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Neomycin Sulfate', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Wool Alcohol', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Potassium Dichromate', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Caine Mix', 'timeFrame': 'Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Fragrance Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Colophony', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Paraben Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Negative Control', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4.'}, {'measure': 'Positive Reactions: Balsam of Peru', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Ethylenediamine Dihydrochloride', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Cobalt Dichloride', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: P-tert Butylphenol Formadehyde Resin', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Epoxy Resin', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Carba Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Black Rubber Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Cl+Me-Isothiazolinone', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Quaternium-15', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Mercaptobenzothiazole', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: p-Phenylenediamine', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Formaldehyde', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Mercapto Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Thimerosal', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Thiuram Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Diazolidinyl Urea', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Imidazolidinyl Urea', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Budesonide', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Tixocortol-21-pivalate', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions at visit 3 and/or visit 4'}, {'measure': 'Positive Reactions: Quinoline Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application', 'description': 'Number of subjects with positive reactions recorded at visit 3 and/or visit 4'}], 'secondaryOutcomes': [{'measure': 'Late Reactions: Nickel Sulfate', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Neomycin Sulfate', 'timeFrame': 'Visit 4: 7 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Wool Alcohol', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Potassium Dichromate', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Caine Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Fragrance Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Colophony', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Paraben Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Negative Control', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Balsam of Peru', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Ethylenediamine Dihydrochloride', 'timeFrame': 'Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Cobalt Dichloride', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: P-tert Butylphenol Formadehyde Resin', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Epoxy Resin', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Carba Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Black Rubber Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Cl+Me-Isothiazolinone', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Quaternium-15', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Mercaptobenzothiazole', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: p-Phenylenediamine', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Formaldehyde', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Mercapto Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Thimerosal', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Thiuram Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Diazolidinyl Urea', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Imidazolidinyl Urea', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Budesonide', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Tixocortol-21-pivalate', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Late Reactions: Quinoline Mix', 'timeFrame': 'Visit 4: 7 days after patch application or Visit 5: 21 days after patch application', 'description': 'Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.'}, {'measure': 'Persistent Reactions: Nickel Sulfate', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Neomycin Sulfate', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Wool Alcohol', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Potassium Dichromate', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Caine Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Fragrance Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Colophony', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Paraben Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Negative Control', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Balsam of Peru', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Ethylenediamine Dihydrochloride', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Cobalt Dichloride', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: P-tert Butylphenol Formadehyde Resin', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Epoxy Resin', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Carba Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Black Rubber Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Cl+Me-Isothiazolinone', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Quaternium-15', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: p-Phenylenediamine', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Formaldehyde', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Mercapto Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Thimerosal', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Thiuram Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Diazolidinyl Urea', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Imidazolidinyl Urea', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Budesonide', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Tixocortol-21-pivalate', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Quinoline Mix', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Persistent Reactions: Mercaptobenzothiazole', 'timeFrame': 'Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application', 'description': 'Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.'}, {'measure': 'Panel Adhesion Evaluation', 'timeFrame': 'Visit 2 (day 1) prior to panel removal.', 'description': 'Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent.'}, {'measure': 'Panel Irritation', 'timeFrame': 'Visit 2 (day 1) following to panel removal.', 'description': 'Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)'}, {'measure': 'Subject Reported Itching and Burning', 'timeFrame': 'Visit 2 (day 1) following to panel removal.', 'description': 'Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergic', 'contact dermatitis', 'contact allergy', 'Type IV', 'Children', 'TRUE TEST'], 'conditions': ['Dermatitis, Contact']}, 'descriptionModule': {'briefSummary': 'Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.', 'detailedDescription': "Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).\n* Children and adolescents 6 to 18 years of age, and in general good health.\n* Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion.\n* Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations.\n\nExclusion Criteria:\n\n* Topical corticosteroid treatment during the last 7 days on or near the test area.\n* Systemic treatment with corticosteroids or other immunosuppressive during the last 7 days.\n* Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.\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 activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).\n* Subjects unable or unwilling to comply with multiple return visits.\n* Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test.'}, 'identificationModule': {'nctId': 'NCT00795951', 'briefTitle': 'Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allerderm'}, 'officialTitle': 'Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents', 'orgStudyIdInfo': {'id': 'MEKOS 07 29P1/2/3/401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRUE Test panels 1.1, 2.1, 3.1', 'description': 'All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control.', 'interventionNames': ['Biological: T.R.U.E. Test']}], 'interventions': [{'name': 'T.R.U.E. Test', 'type': 'BIOLOGICAL', 'otherNames': ['NA no other names'], 'description': '48 hour application of 28 allergens and negative control', 'armGroupLabels': ['TRUE Test panels 1.1, 2.1, 3.1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Lawrence Eichenfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allerderm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}