Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-26 @ 4:27 AM
Study NCT ID:
NCT00612768
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2008-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003877', 'term': 'Dermatitis, Contact'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013849', 'term': 'Thimerosal'}], 'ancestors': [{'id': 'D005035', 'term': 'Ethylmercury Compounds'}, {'id': 'D000479', 'term': 'Alkylmercury Compounds'}, {'id': 'D009941', 'term': 'Organomercury Compounds'}, {'id': 'D009942', 'term': 'Organometallic Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kshannon@smarthealth.com', 'phone': '602-225-0595', 'title': 'Kathy Shannon', 'phoneExt': '7208', 'organization': 'SmartPractice'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 0-21', 'eventGroups': [{'id': 'EG000', 'title': 'Sensitives', 'description': 'subjects per allergen with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.', 'otherNumAtRisk': 50, 'otherNumAffected': 5, 'seriousNumAtRisk': 50, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bladder Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching and burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching on/around site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reports burning sensation, she thinks it might be due to the tape', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching at positive patch sites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Right femoral sheath placed secondary to tronsientischemic attack/carotid stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Analysis of Bioequivalence: Concordance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fragrance Mix', 'description': 'Percent agreement between T.R.U.E. Test allergen in PVP vs HPC'}, {'id': 'OG001', 'title': 'Thimerosol', 'description': 'Percent agreement between T.R.U.E. Test allergen in PVP vs HPC'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '61.8', 'upperLimit': '86.9'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit', 'unitOfMeasure': 'percentage of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The data from 50 subjects enrolled in the study was analyzed'}, {'type': 'PRIMARY', 'title': 'Agreement Between TRUE Test Allergen and Reference Allergen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensitivity: Fragrance Mix in HPC', 'description': 'Agreement between positive results for the test and reference allergen'}, {'id': 'OG001', 'title': 'Sensitivity: Fragrance Mix in PVP', 'description': 'Agreement between positive results for the test and reference allergen'}, {'id': 'OG002', 'title': 'Sensitivity: Thimerosal in HPC', 'description': 'Agreement between positive results for the test and reference allergen'}, {'id': 'OG003', 'title': 'Sensitivity: Thimerosol in PVP', 'description': 'Agreement between positive results for the test and reference allergen'}, {'id': 'OG004', 'title': 'Specificity: Fragrance Mix in HPC', 'description': 'Agreement between negative results for the test and reference allergen'}, {'id': 'OG005', 'title': 'Specificity: Fragrance Mix in PVP', 'description': 'Agreement between negative results for the test and reference allergen'}, {'id': 'OG006', 'title': 'Specificity: Thimerosal in HPC', 'description': 'Agreement between negative results for the test and reference allergen'}, {'id': 'OG007', 'title': 'Specificity: Thimerosal in PVP', 'description': 'Agreement between negative results for the test and reference allergen'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '59.1', 'groupId': 'OG001', 'lowerLimit': '36.4', 'upperLimit': '79.3'}, {'value': '61.5', 'groupId': 'OG002', 'lowerLimit': '40.6', 'upperLimit': '79.8'}, {'value': '65.4', 'groupId': 'OG003', 'lowerLimit': '44.3', 'upperLimit': '82.8'}, {'value': '92.9', 'groupId': 'OG004', 'lowerLimit': '76.5', 'upperLimit': '99.1'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '87.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '85.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '85.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen', 'unitOfMeasure': 'percentage of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The data from all enrolled subjects was analyzed.'}, {'type': 'SECONDARY', 'title': 'Irritation, Adhesion, Itching/Burning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tape Irritation: TRUE Test Panel', 'description': 'Percentage of participants who exhibited tape-induced irritation at visit 2.'}, {'id': 'OG001', 'title': 'Incomplete Panel Adhesion: TRUE Test', 'description': 'Percentage of participants whose panels were not 100% adhered at visit 2.'}, {'id': 'OG002', 'title': 'Incomplete Panel Adhesion: Reference Allergen', 'description': 'Percentage of participants whose panels were not 100% adhered at visit 2.'}, {'id': 'OG003', 'title': 'Itching and Burning', 'description': 'Percentage of participants who reported patch related itching and/or burning at visit 2'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2: 48 hours after patch application', 'description': 'Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Late and Persistent Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Late Reactions: Fragrance Mix in HPC', 'description': 'Late reactions occur 7-10 days after patch application'}, {'id': 'OG001', 'title': 'Late Reactions: Fragrance Mix in PVP', 'description': 'Late reactions occur 7-10 days after patch application'}, {'id': 'OG002', 'title': 'Late Reactions: Thimerosal in HPC', 'description': 'Late reactions occur 7-10 days after patch application'}, {'id': 'OG003', 'title': 'Late Reactions: Thimerosol in PVP', 'description': 'Late reactions occur 7-10 days after patch application'}, {'id': 'OG004', 'title': 'Persistent Reactions: Fragrance Mix in HPC', 'description': 'Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application'}, {'id': 'OG005', 'title': 'Persistent Reactions: Fragrance Mix in PVP', 'description': 'Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application'}, {'id': 'OG006', 'title': 'Persistent Reactions: Thimerosal in HPC', 'description': 'Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application'}, {'id': 'OG007', 'title': 'Persistent Reactions: Thimerosal in PVP', 'description': 'Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2 (48 hours after application) through Day 21', 'description': 'Late 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 subjects with reactions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sensitive Subjects', 'description': 'All subjects recruited to this study were to have had previous positive patch test results to one of the allergens tested on the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 4 centers in the United States. The first subject was enrolled on Jan 2 2008 and the study completed on Dec 12 2008.', 'preAssignmentDetails': 'No subject was excluded from the trial following enrollment but before assignment to a group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sensitive Subjects', 'description': 'Subjects with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise 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': '40', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '16.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-06', 'studyFirstSubmitDate': '2008-01-30', 'resultsFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2008-01-30', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-06', 'studyFirstPostDateStruct': {'date': '2008-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of Bioequivalence: Concordance', 'timeFrame': 'Up to 21 days', 'description': 'Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit'}, {'measure': 'Agreement Between TRUE Test Allergen and Reference Allergen', 'timeFrame': 'Up to 21 days', 'description': 'Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen'}], 'secondaryOutcomes': [{'measure': 'Irritation, Adhesion, Itching/Burning', 'timeFrame': 'Visit 2: 48 hours after patch application', 'description': 'Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.'}, {'measure': 'Frequency of Late and Persistent Reactions', 'timeFrame': 'Day 2 (48 hours after application) through Day 21', 'description': 'Late 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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Thimerosal', 'Fragrance Mix', 'PVP formulation', 'Contact dermatitis'], 'conditions': ['Dermatitis, Contact']}, 'descriptionModule': {'briefSummary': 'Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.', 'detailedDescription': 'Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, '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 fragrance mix AND/OR thimerosal.\n* All subjects must be adults (18 years of age or older) and otherwise in good health.\n* Pre-menopausal 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': 'NCT00612768', 'briefTitle': 'Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allerderm'}, 'officialTitle': 'Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of Polyvinylpyrrolidone (PVP) Formulations', 'orgStudyIdInfo': {'id': 'Mekos 07 2P1/2 401'}, 'secondaryIdInfos': [{'id': '20071738', 'type': 'OTHER', 'domain': 'Western Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T.R.U.E. Test allergens Fragrance Mix and Thimerosol', 'description': 'Concordance (agreement) between positive patch reactions to\n\n1. fragrance mix (0.43 mg/cm2) in polyvinylpyrrolidone (PVP) vs fragrance mix (0.43 mg/cm2) in hydroxypropylcellulose (HPC)\n2. thimerosol (0.008 mg/cm2) in polyvinylpyrrolidone (PVP) vs thimerosol (0.008 mg/cm2) in hydroxypropylcellulose (HPC)\n3. fragrance mix T.R.U.E. Test allergen vs fragrance mix reference allergen (petrolatum)\n4. thimerosol T.R.U.E. Test allergen vs thimerosol reference allergen (petrolatum)\n\nwill be measured', 'interventionNames': ['Biological: TRUE Test allergens Fragrance Mix and Thimerosol']}], 'interventions': [{'name': 'TRUE Test allergens Fragrance Mix and Thimerosol', 'type': 'BIOLOGICAL', 'otherNames': ['T.R.U.E. TEST Skin Patch Test'], 'description': '* Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose\n* Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone\n* Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin\n* Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin\n\nPatches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.', 'armGroupLabels': ['T.R.U.E. Test allergens Fragrance Mix and Thimerosol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'River City Dermatology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '66216', 'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'American Dermatology Associates', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '40202-1864', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Dermatology Specialists PSC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}], 'overallOfficials': [{'name': 'Joseph Fowler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Specialists PSC'}, {'name': 'Luz Fonacier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winthrop University Hospital'}, {'name': 'Donald V. Belsito, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Dermatology Associates'}, {'name': 'Jerri Hoskyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'River City Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allerderm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}