Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04378569
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2020-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@arcutis.com', 'phone': '+1 (844) 692-6729', 'title': 'Arcutis Medical Information', 'organization': 'Arcutis Biotherapeutics'}, 'certainAgreement': {'otherDetails': 'The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to ~14 weeks', 'description': 'All treated participants are included.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 2, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 2, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 3, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 2, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 1, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohort 1: Number of Participants With ≥1 Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.'}, {'id': 'OG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 weeks', 'description': "The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1 are included.'}, {'type': 'PRIMARY', 'title': 'Cohort 1: Number of Participants With an Application Site Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.'}, {'id': 'OG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 weeks', 'description': 'The number of Cohort 1 participants with AEs coded as application site events is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1 are included.'}, {'type': 'PRIMARY', 'title': 'Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.'}, {'id': 'OG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 weeks', 'description': "The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1 are included.'}, {'type': 'PRIMARY', 'title': 'Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.'}, {'id': 'OG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 weeks', 'description': 'The number of Cohort 1 participants with a significant change in hematology is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1 are included.'}, {'type': 'PRIMARY', 'title': 'Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.'}, {'id': 'OG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 weeks', 'description': 'The number of Cohort 1 participants with a significant change in chemistry is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1 are included.'}, {'type': 'PRIMARY', 'title': "Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream (Pooled)', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.5788', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.53', 'estimateComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data'}, {'pValue': '0.6488', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.33', 'ciUpperLimit': '2.17', 'estimateComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data'}, {'pValue': '0.5653', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.32', 'ciUpperLimit': '2.25', 'estimateComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.'}, {'type': 'SECONDARY', 'title': "Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.5033', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.25', 'ciUpperLimit': '2.78', 'estimateComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data'}, {'pValue': '0.4975', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.25', 'ciUpperLimit': '2.79', 'estimateComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.04', 'ciUpperLimit': '2.55', 'pValueComment': 'P value was not evaluable', 'estimateComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 2, 4, 8 and 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' plus ≥2-point improvement (ie, decrease) from Baseline is presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7237', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.23', 'ciUpperLimit': '2.44', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.8380', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.17', 'ciUpperLimit': '2.10', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.04', 'ciUpperLimit': '2.55', 'pValueComment': 'p-value was unevaluable', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 2, 4, 8 and 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline in IGA score is presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.'}, {'type': 'SECONDARY', 'title': "Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.9604', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.31', 'ciUpperLimit': '3.07', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.9752', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.32', 'ciUpperLimit': '3.25', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.5077', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.11', 'ciUpperLimit': '3.03', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.5916', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.26', 'ciUpperLimit': '2.15', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.3320', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.27', 'ciUpperLimit': '1.57', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.1922', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.14', 'ciUpperLimit': '1.57', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.4188', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.81', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.5520', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.92', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}, {'pValue': '0.69', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.21', 'ciUpperLimit': '2.20', 'estimateComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 2, 4, and 8', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline is presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.'}, {'type': 'SECONDARY', 'title': "Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '-0.35', 'spread': '0.143', 'groupId': 'OG003'}, {'value': '-0.48', 'spread': '0.105', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '0.129', 'groupId': 'OG002'}, {'value': '-0.58', 'spread': '0.174', 'groupId': 'OG003'}, {'value': '-0.72', 'spread': '0.129', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.149', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.153', 'groupId': 'OG002'}, {'value': '-0.57', 'spread': '0.203', 'groupId': 'OG003'}, {'value': '-0.78', 'spread': '0.150', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.04', 'spread': '0.149', 'groupId': 'OG001'}, {'value': '-0.93', 'spread': '0.155', 'groupId': 'OG002'}, {'value': '-0.73', 'spread': '0.205', 'groupId': 'OG003'}, {'value': '-0.80', 'spread': '0.150', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.6464', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.21', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'nonInferiorityComment': 'Week 2'}, {'pValue': '0.8881', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.25', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.4360', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.46', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.8196', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.36', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.9217', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.34', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.4783', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.53', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.7725', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.43', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.7861', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.33', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.3521', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.68', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.2166', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.14', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.5262', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.27', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}, {'pValue': '0.7575', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.54', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The mean change from baseline in IGA score is presented, with lower scores indicating a reduction in symptom severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 are included.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.43', 'spread': '0.365', 'groupId': 'OG001'}, {'value': '-2.25', 'spread': '0.360', 'groupId': 'OG002'}, {'value': '-3.16', 'spread': '0.469', 'groupId': 'OG003'}, {'value': '-1.80', 'spread': '0.355', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '0.359', 'groupId': 'OG001'}, {'value': '-2.48', 'spread': '0.372', 'groupId': 'OG002'}, {'value': '-3.75', 'spread': '0.504', 'groupId': 'OG003'}, {'value': '-2.49', 'spread': '0.373', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.39', 'spread': '0.338', 'groupId': 'OG001'}, {'value': '-2.85', 'spread': '0.361', 'groupId': 'OG002'}, {'value': '-3.48', 'spread': '0.476', 'groupId': 'OG003'}, {'value': '-2.64', 'spread': '0.362', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.71', 'spread': '0.323', 'groupId': 'OG001'}, {'value': '-3.39', 'spread': '0.349', 'groupId': 'OG002'}, {'value': '-3.87', 'spread': '0.444', 'groupId': 'OG003'}, {'value': '-3.08', 'spread': '0.354', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': 'The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean change from baseline in WI-NRS is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 with data available are included.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2662', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.64', 'ciUpperLimit': '4.70', 'estimateComment': 'Stratified', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified'}, {'pValue': '0.3798', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '0.59', 'ciUpperLimit': '4.00', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0611', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.18', 'ciLowerLimit': '0.90', 'ciUpperLimit': '11.17', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3129', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '0.64', 'ciUpperLimit': '3.93', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9586', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.35', 'ciUpperLimit': '2.74', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0643', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.65', 'ciLowerLimit': '0.87', 'ciUpperLimit': '15.29', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0932', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '0.84', 'ciUpperLimit': '6.88', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5730', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.44', 'ciUpperLimit': '4.59', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0389', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.96', 'ciLowerLimit': '0.96', 'ciUpperLimit': '25.66', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2813', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '0.60', 'ciUpperLimit': '5.53', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6841', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.17', 'ciUpperLimit': '3.03', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3113', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '0.49', 'ciUpperLimit': '9.21', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': 'The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours (higher scores indicate higher itch severity). The mean change from baseline in WI-NRS is reported. The number of participants with a baseline WI-NRS score of ≥4 who achieved a ≥4-point reduction is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Cohort 2 with data available and who had baseline WI-NRS scores ≥4 are included.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-18.3', 'spread': '27.39', 'groupId': 'OG001'}, {'value': '-13.6', 'spread': '21.67', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '22.37', 'groupId': 'OG003'}, {'value': '-12.4', 'spread': '31.84', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-21.3', 'spread': '28.38', 'groupId': 'OG001'}, {'value': '-21.0', 'spread': '24.78', 'groupId': 'OG002'}, {'value': '-8.8', 'spread': '20.22', 'groupId': 'OG003'}, {'value': '-14.6', 'spread': '30.89', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-22.7', 'spread': '29.50', 'groupId': 'OG001'}, {'value': '-19.7', 'spread': '27.12', 'groupId': 'OG002'}, {'value': '-8.3', 'spread': '25.16', 'groupId': 'OG003'}, {'value': '-17.8', 'spread': '33.15', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-25.8', 'spread': '30.25', 'groupId': 'OG001'}, {'value': '-26.3', 'spread': '29.85', 'groupId': 'OG002'}, {'value': '-14.5', 'spread': '19.19', 'groupId': 'OG003'}, {'value': '-18.6', 'spread': '36.12', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': 'The HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) on 5 areas of the hand (fingertips, fingers \\[except tips\\], palm, back of hand, wrists) by use of a standard scale. Each subscale is scored from 0 to 60; the total HECSI score ranges from 0 to 360 with higher scores indicating greater symptom severity. The mean change from baseline in HECSI is reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 with data available are included.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '2.368', 'groupId': 'OG001'}, {'value': '-1.74', 'spread': '2.464', 'groupId': 'OG002'}, {'value': '-1.86', 'spread': '2.923', 'groupId': 'OG003'}, {'value': '-0.71', 'spread': '2.298', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.18', 'spread': '2.611', 'groupId': 'OG001'}, {'value': '-1.66', 'spread': '2.704', 'groupId': 'OG002'}, {'value': '-2.34', 'spread': '2.897', 'groupId': 'OG003'}, {'value': '-0.88', 'spread': '2.176', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.15', 'spread': '2.722', 'groupId': 'OG001'}, {'value': '-1.64', 'spread': '3.062', 'groupId': 'OG002'}, {'value': '-2.29', 'spread': '3.224', 'groupId': 'OG003'}, {'value': '-0.89', 'spread': '2.205', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.58', 'spread': '2.700', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '2.708', 'groupId': 'OG002'}, {'value': '-2.11', 'spread': '3.439', 'groupId': 'OG003'}, {'value': '-1.06', 'spread': '2.602', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': "The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The mean change from baseline NRS Pain score is reported.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 with data available are included.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2674', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '0.46', 'ciUpperLimit': '10.67', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.2850', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '0.44', 'ciUpperLimit': '17.54', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.3086', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '0.42', 'ciUpperLimit': '16.52', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.1655', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.33', 'ciLowerLimit': '0.46', 'ciUpperLimit': '40.83', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.7154', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.26', 'ciUpperLimit': '7.67', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.5371', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '0.27', 'ciUpperLimit': '14.64', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.2170', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.00', 'ciLowerLimit': '0.43', 'ciUpperLimit': '57.83', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.3408', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.74', 'ciLowerLimit': '0.41', 'ciUpperLimit': '18.22', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.3270', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '0.41', 'ciUpperLimit': '14.20', 'estimateComment': 'Stratified by pooled site group and baseline IGA grade', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.0719', 'groupIds': ['OG001', 'OG004'], 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.8527', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.07', 'ciUpperLimit': '8.43', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}, {'pValue': '0.3545', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.20', 'ciLowerLimit': '0.37', 'ciUpperLimit': '13.11', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by pooled site group and baseline IGA grade'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': "The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The number of participants with ≥4-point reduction from baseline NRS Pain score is reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who had baseline NRS Pain scores ≥4 and with data available are included.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-13.7', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '-15.1', 'spread': '1.92', 'groupId': 'OG002'}, {'value': '-11.0', 'spread': '2.64', 'groupId': 'OG003'}, {'value': '-9.3', 'spread': '1.86', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-17.4', 'spread': '2.44', 'groupId': 'OG001'}, {'value': '-18.5', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '-15.3', 'spread': '3.45', 'groupId': 'OG003'}, {'value': '-13.4', 'spread': '2.56', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-16.6', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '-19.6', 'spread': '2.61', 'groupId': 'OG002'}, {'value': '-20.8', 'spread': '3.65', 'groupId': 'OG003'}, {'value': '-12.0', 'spread': '2.67', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-19.2', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-24.9', 'spread': '2.95', 'groupId': 'OG002'}, {'value': '-22.3', 'spread': '3.89', 'groupId': 'OG003'}, {'value': '-15.3', 'spread': '3.04', 'groupId': 'OG004'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-20.9', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-22.9', 'spread': '2.89', 'groupId': 'OG002'}, {'value': '-18.9', 'spread': '3.81', 'groupId': 'OG003'}, {'value': '-15.6', 'spread': '3.04', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0725', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '0.4', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.0183', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.8', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '-1.0', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.5701', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '4.3', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.2116', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-10.4', 'ciUpperLimit': '2.3', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.1235', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-11.5', 'ciUpperLimit': '1.4', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.6334', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-9.7', 'ciUpperLimit': '5.9', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.1788', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '2.1', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.0292', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.6', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '-0.8', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.0371', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-17.1', 'ciUpperLimit': '-0.5', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.2971', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-11.3', 'ciUpperLimit': '3.5', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.0150', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '-1.9', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.1245', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '1.9', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.1591', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '2.1', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.0600', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-14.8', 'ciUpperLimit': '0.3', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}, {'pValue': '0.4640', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '5.5', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, and baseline IGA were independent variables'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 8, 12, 13', 'description': "The QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. The scoring ranges from 0 ('no eczema') to 117 ('most severe eczema').", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 with data available are included.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'OG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'OG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'OG004', 'title': 'Cohort 2: Vehicle Cream Pooled', 'description': 'Participants applied ARQ-252 Vehicle Cream QD or BID to both hands for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.185', 'spread': '0.0517', 'groupId': 'OG001'}, {'value': '-0.132', 'spread': '0.0559', 'groupId': 'OG002'}, {'value': '-0.028', 'spread': '0.0697', 'groupId': 'OG003'}, {'value': '-0.119', 'spread': '0.0509', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.310', 'spread': '0.0583', 'groupId': 'OG001'}, {'value': '-0.319', 'spread': '0.0634', 'groupId': 'OG002'}, {'value': '-0.151', 'spread': '0.0818', 'groupId': 'OG003'}, {'value': '-0.139', 'spread': '0.0616', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.319', 'spread': '0.0746', 'groupId': 'OG001'}, {'value': '-0.273', 'spread': '0.0808', 'groupId': 'OG002'}, {'value': '-0.241', 'spread': '0.1039', 'groupId': 'OG003'}, {'value': '-0.223', 'spread': '0.0744', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.429', 'spread': '0.0681', 'groupId': 'OG001'}, {'value': '-0.409', 'spread': '0.0759', 'groupId': 'OG002'}, {'value': '-0.296', 'spread': '0.0948', 'groupId': 'OG003'}, {'value': '-0.307', 'spread': '0.0751', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.3184', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.066', 'ciLowerLimit': '-0.196', 'ciUpperLimit': '0.064', 'estimateComment': 'Treatment group, pooled site group, and baseline IGA were independent variables', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.8514', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.013', 'ciLowerLimit': '-0.149', 'ciUpperLimit': '0.123', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.2603', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.091', 'ciLowerLimit': '-0.068', 'ciUpperLimit': '0.249', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.0273', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.171', 'ciLowerLimit': '-0.323', 'ciUpperLimit': '-0.019', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.0266', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.180', 'ciLowerLimit': '-0.339', 'ciUpperLimit': '-0.021', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.9023', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.196', 'ciUpperLimit': '0.173', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.3298', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.291', 'ciUpperLimit': '0.098', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.6205', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.050', 'ciLowerLimit': '-0.251', 'ciUpperLimit': '0.150', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.8817', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.018', 'ciLowerLimit': '-0.253', 'ciUpperLimit': '0.217', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.1837', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.122', 'ciLowerLimit': '-0.302', 'ciUpperLimit': '0.058', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.2896', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.102', 'ciLowerLimit': '-0.293', 'ciUpperLimit': '0.088', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}, {'pValue': '0.9190', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '-0.205', 'ciUpperLimit': '0.227', 'estimateComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 8, 12', 'description': "The percentage of total body surface area (BSA) affected by chronic hand eczema (CHE) is a measure of the area of the subject's hands that is affected by CHE lesions, expressed as a percentage of total BSA. Based on the subject's hand method, the BSA of 1 side of 1 hand is assumed to be 1% of total BSA. The surface area of lesions on both sides of both hands are added to calculate the total BSA affected by CHE. The total BSA affected by CHE ranges from 0% (no CHE lesions) to 4% (the entire front and back sides of both hands are affected by CHE lesions).", 'unitOfMeasure': 'Percentage of Total BSA', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 with data available are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'FG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'FG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'FG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'FG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.'}, {'id': 'FG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Lack of response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 36 centers in the United States, Canada, and Australia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks.'}, {'id': 'BG001', 'title': 'Cohort 2: ARQ-252 Cream 0.3% QD', 'description': 'Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks.'}, {'id': 'BG002', 'title': 'Cohort 2: ARQ-252 Cream 0.3% BID', 'description': 'Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks.'}, {'id': 'BG003', 'title': 'Cohort 2: ARQ-252 Cream 0.1% QD', 'description': 'Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks.'}, {'id': 'BG004', 'title': 'Cohort 2: Vehicle Cream QD', 'description': 'Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks.'}, {'id': 'BG005', 'title': 'Cohort 2: Vehicle Cream BID', 'description': 'Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '45.4', 'spread': '9.18', 'groupId': 'BG000'}, {'value': '41.6', 'spread': '15.08', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '15.05', 'groupId': 'BG002'}, {'value': '41.6', 'spread': '15.33', 'groupId': 'BG003'}, {'value': '40.3', 'spread': '12.06', 'groupId': 'BG004'}, {'value': '43.3', 'spread': '13.36', 'groupId': 'BG005'}, {'value': '42.2', 'spread': '14.24', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '140', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '180', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Investigator Global Assessment (IGA) Categorical Scores at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'categories': [{'title': '0 - Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': '1 - Almost Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': '2 - Mild', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}, {'title': '3 - Moderate', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '157', 'groupId': 'BG006'}]}, {'title': '4 - Severe', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity.", 'unitOfMeasure': 'Participants'}, {'title': 'IGA Mean Scores at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.58', 'groupId': 'BG000'}, {'value': '2.9', 'spread': '0.56', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '0.53', 'groupId': 'BG002'}, {'value': '2.8', 'spread': '0.57', 'groupId': 'BG003'}, {'value': '2.9', 'spread': '0.61', 'groupId': 'BG004'}, {'value': '2.8', 'spread': '0.55', 'groupId': 'BG005'}, {'value': '2.9', 'spread': '0.56', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': "The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '227', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '2.56', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '2.45', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '2.75', 'groupId': 'BG002'}, {'value': '6.0', 'spread': '3.19', 'groupId': 'BG003'}, {'value': '5.5', 'spread': '2.83', 'groupId': 'BG004'}, {'value': '5.0', 'spread': '2.80', 'groupId': 'BG005'}, {'value': '5.7', 'spread': '2.74', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours (higher scores indicate higher itch severity).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants with baseline data available are included.'}, {'title': 'Hand Eczema Severity Index (HECSI) Mean Baseline Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '230', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '57.4', 'spread': '58.35', 'groupId': 'BG000'}, {'value': '43.7', 'spread': '31.43', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '35.74', 'groupId': 'BG002'}, {'value': '37.1', 'spread': '34.51', 'groupId': 'BG003'}, {'value': '45.8', 'spread': '50.31', 'groupId': 'BG004'}, {'value': '38.9', 'spread': '32.72', 'groupId': 'BG005'}, {'value': '42.9', 'spread': '37.08', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'The HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) on 5 areas of the hand (fingertips, fingers \\[except tips\\], palm, back of hand, wrists) by use of a standard scale. Each subscale is scored from 0 to 60; the total HECSI score ranges from 0 to 360 with higher scores indicating greater symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-30', 'size': 976398, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-15T08:40', 'hasProtocol': True}, {'date': '2021-04-09', 'size': 3217891, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-15T08:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 2 cohorts of subjects.\n\n* Cohort 1 (Phase 1) is a multiple dose cohort in which subjects with chronic hand eczema will be assigned to ARQ-252 cream 0.3% QD x 2 weeks to be applied to both hands (approximately 4% of BSA).\n* Cohort 2 (Phase 2b) is a parallel group, double blind, vehicle-controlled cohort in which subjects with chronic hand eczema will be randomized to ARQ-252 cream 0.3% QD, ARQ-252 cream 0.3% BID, ARQ-252 cream 0.1% QD, vehicle cream BID or vehicle cream QD x 12 weeks to be applied to both hands (approximately 4% of BSA).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2021-12-20', 'completionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2020-04-30', 'resultsFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2020-05-04', 'dispFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-03', 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: Number of Participants With ≥1 Adverse Event (AE)', 'timeFrame': 'Up to 3 weeks', 'description': "The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research."}, {'measure': 'Cohort 1: Number of Participants With an Application Site Reaction', 'timeFrame': 'Up to 3 weeks', 'description': 'The number of Cohort 1 participants with AEs coded as application site events is reported.'}, {'measure': 'Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)', 'timeFrame': 'Up to 3 weeks', 'description': "The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health."}, {'measure': 'Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters', 'timeFrame': 'Up to 3 weeks', 'description': 'The number of Cohort 1 participants with a significant change in hematology is reported.'}, {'measure': 'Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters', 'timeFrame': 'Up to 3 weeks', 'description': 'The number of Cohort 1 participants with a significant change in chemistry is reported.'}, {'measure': "Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12", 'timeFrame': 'Week 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented."}], 'secondaryOutcomes': [{'measure': "Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline", 'timeFrame': 'Weeks 2, 4, 8 and 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' plus ≥2-point improvement (ie, decrease) from Baseline is presented."}, {'measure': 'Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline', 'timeFrame': 'Weeks 2, 4, 8 and 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline in IGA score is presented."}, {'measure': "Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'", 'timeFrame': 'Weeks 2, 4, and 8', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline is presented."}, {'measure': "Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score", 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': "The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The mean change from baseline in IGA score is presented, with lower scores indicating a reduction in symptom severity."}, {'measure': 'Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': 'The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean change from baseline in WI-NRS is reported.'}, {'measure': 'Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': 'The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours (higher scores indicate higher itch severity). The mean change from baseline in WI-NRS is reported. The number of participants with a baseline WI-NRS score of ≥4 who achieved a ≥4-point reduction is reported.'}, {'measure': 'Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': 'The HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) on 5 areas of the hand (fingertips, fingers \\[except tips\\], palm, back of hand, wrists) by use of a standard scale. Each subscale is scored from 0 to 60; the total HECSI score ranges from 0 to 360 with higher scores indicating greater symptom severity. The mean change from baseline in HECSI is reported.'}, {'measure': 'Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': "The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The mean change from baseline NRS Pain score is reported."}, {'measure': 'Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score', 'timeFrame': 'Weeks 2, 4, 8, and 12', 'description': "The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The number of participants with ≥4-point reduction from baseline NRS Pain score is reported."}, {'measure': 'Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit', 'timeFrame': 'Weeks 2, 4, 8, 12, 13', 'description': "The QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. The scoring ranges from 0 ('no eczema') to 117 ('most severe eczema')."}, {'measure': 'Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease', 'timeFrame': 'Weeks 2, 4, 8, 12', 'description': "The percentage of total body surface area (BSA) affected by chronic hand eczema (CHE) is a measure of the area of the subject's hands that is affected by CHE lesions, expressed as a percentage of total BSA. Based on the subject's hand method, the BSA of 1 side of 1 hand is assumed to be 1% of total BSA. The surface area of lesions on both sides of both hands are added to calculate the total BSA affected by CHE. The total BSA affected by CHE ranges from 0% (no CHE lesions) to 4% (the entire front and back sides of both hands are affected by CHE lesions)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hand Eczema']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema', 'detailedDescription': 'This is a Phase 1/2b multiple dose, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Participants legally competent to sign and give informed consent.\n* Males and females 18 years of age and older (inclusive) at the time of consent.\n* Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more than 3 months, or returned twice or more within the last 12 months. Generally stable disease for 6 weeks.\n* Chronic hand eczema involving at least 0.3% body surface area total (i.e., approximately a third of one handprint) lesions on both hands added together\n* Female subjects of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. For FOCBP involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method for at least 4 weeks prior to Day 1. Additionally, from Day 1 until at least 4 weeks after the last investigational product administration, these subjects must agree to use at least 1 highly effective contraceptive method in addition to 1 barrier method according to the Contraception Requirements Section of the protocol.\n* Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.\n* Males, if engaging in sexual intercourse with a female who is pregnant or a female of childbearing potential, must agree to use a condom every time during the study and every and every time subsequently until 4 weeks after the last dose of investigational product.\n* Subjects in good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.\n\nExclusion Criteria\n\n* Concurrent skin diseases on the hands which, in the opinion of the Investigator, could confound the study (e.g., tinnea manuum).\n* Subjects with any presence or history of psoriasis.\n* History of a positive patch test with continued exposure to allergen. Subjects must have undergone diagnostic patch testing within 3 years prior to Baseline (Visit 2).\n* Subjects who cannot discontinue systemic and/or topical therapies for the treatment of chronic hand eczema prior to Baseline and during the study\n* Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Baseline\n* Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of investigational product.\n* Subjects with any serious medical condition or clinically significant laboratory, ECG, vital signs or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.'}, 'identificationModule': {'nctId': 'NCT04378569', 'briefTitle': 'Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcutis Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 1/2b, Multiple Dose and 12-Week, Parallel Group, Double Blind, Dose Ranging, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.1% and ARQ-252 Cream 0.3% in Subjects With Chronic Hand Eczema', 'orgStudyIdInfo': {'id': 'ARQ-252-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARQ-252 cream 0.3% QD (once daily)', 'description': 'Active Comparator', 'interventionNames': ['Drug: ARQ-252 cream 0.3%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ARQ-252 cream 0.3% BID (twice daily)', 'description': 'Active Comparator', 'interventionNames': ['Drug: ARQ-252 cream 0.3%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ARQ-252 cream 0.1% QD (once daily)', 'description': 'Active Comparator', 'interventionNames': ['Drug: ARQ-252 cream 0.1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle cream BID (twice daily)', 'description': 'Placebo Comparator', 'interventionNames': ['Drug: ARQ-252 Vehicle Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle cream QD (once daily)', 'description': 'Placebo Comparator', 'interventionNames': ['Drug: ARQ-252 Vehicle Cream']}], 'interventions': [{'name': 'ARQ-252 cream 0.3%', 'type': 'DRUG', 'description': 'ARQ-252 cream 0.3%', 'armGroupLabels': ['ARQ-252 cream 0.3% BID (twice daily)', 'ARQ-252 cream 0.3% QD (once daily)']}, {'name': 'ARQ-252 cream 0.1%', 'type': 'DRUG', 'description': 'ARQ-252 cream 0.1%', 'armGroupLabels': ['ARQ-252 cream 0.1% QD (once daily)']}, {'name': 'ARQ-252 Vehicle Cream', 'type': 'DRUG', 'description': 'ARQ-252 Vehicle Cream', 'armGroupLabels': ['Vehicle cream BID (twice daily)', 'Vehicle cream QD (once daily)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 239', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 225', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 112', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92797', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 120', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 208', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 174', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 167', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 104', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Arcutis Clinical Site 214', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Arcutis Clinical Site 217', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arcutis Clinical Site 213', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Arcutis Clinical Site 125', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 212', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55112', 'city': 'New Brighton', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Arcutis Clinical Site 216', 'geoPoint': {'lat': 45.06552, 'lon': -93.20189}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Arcutis Clinical Site 171', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Arcutis Clinical Site 115', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Arcutis Clinical Site 173', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Arcutis Clinical Site 135', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 162', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 104', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 164', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 163', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 161', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 110', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Arcutis Clinical Site 169', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Arcutis Clinical Site 306', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Arcutis Clinical Site 303', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 207', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 205', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 218', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 103', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 133', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 165', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 109', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 241', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 106', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Arcutis Clinical Site 242', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'David Berk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arcutis Biotherapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcutis Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}