Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT05032859
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pdrl@organon.com', 'phone': '551-430-6000', 'title': 'Clinical Lead, Late-Stage Clinical Development', 'organization': 'Organon and Co'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, up to 9 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 55, 'seriousNumAtRisk': 271, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 13, 'seriousNumAtRisk': 133, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Psychogenic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}, {'value': '18.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.27', 'ciLowerLimit': '1.54', 'ciUpperLimit': '3.32', 'estimateComment': 'Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.', 'groupDescription': 'H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Baseline vIGA-AD Score and Age Group'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.\n\nStatistics are based on 100 imputed datasets.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (MI Estimand)'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.14', 'ciLowerLimit': '1.53', 'ciUpperLimit': '3.00', 'estimateComment': 'Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.\n\nStatistics are based on 100 imputed datasets.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (MI Estimand)'}, {'type': 'SECONDARY', 'title': 'Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.36', 'spread': '0.540', 'groupId': 'OG000'}, {'value': '-3.14', 'spread': '0.676', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.60', 'ciLowerLimit': '-8.17', 'ciUpperLimit': '-5.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.803', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'age\\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'Assessment of percent body surface area (%BSA) is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% \\[10 handprints\\], upper extremities = 20% \\[20 handprints\\], trunk (including axillae and groin) = 30% \\[30 handprints\\], lower extremities, including buttocks, = 40% \\[40 handprints\\]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.', 'unitOfMeasure': 'Change in affected BSA percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (MI Estimand)'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.34', 'ciLowerLimit': '1.39', 'ciUpperLimit': '3.94', 'estimateComment': 'Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Baseline vIGA-AD Score and Age Group', 'otherAnalysisDescription': 'Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.\n\nStatistics are based on 100 imputed datasets.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (MI Estimand)'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects ≥ 12 Years Old With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the Average Weekly PP-NRS From Baseline to Week 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily'}, {'id': 'OG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '1.34', 'ciUpperLimit': '3.50', 'estimateComment': 'Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Baseline vIGA-AD Score and Age Group'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.\n\nStatistics are based on 100 imputed datasets.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (MI Estimand)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily'}, {'id': 'FG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}], 'recruitmentDetails': 'Participants from the main study (DMVT-505-3102) had the option to participate in the open label extension study (DMVT-505-3103, NCT05142774).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tapinarof Cream', 'description': 'tapinarof cream, 1%, applied topically once daily'}, {'id': 'BG001', 'title': 'Vehicle Cream', 'description': 'vehicle cream, applied topically once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '16.24', 'groupId': 'BG000'}, {'value': '16.7', 'spread': '16.05', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '16.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '2-6 Years', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': '7-11 Years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': '12-17 Years', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': '≥18 Years', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Count of participants'}, {'title': 'Validated Investigator Global Assessment for Atopic Dermatitis', 'classes': [{'categories': [{'title': '0 - Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '1 - Almost Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '2 - Mild', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '3 - Moderate', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}, {'title': '4 - Severe', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Grading (per protocol score definition):\n\n* 0: Clear - No inflammatory signs of atopic dermatitis.\n* 1: Almost Clear - Barely perceptible erythema, induration/papulation, and/or minimal lichenification.\n* 2: Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification.\n* 3: Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification.\n* 4: Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.', 'unitOfMeasure': 'Participants'}, {'title': 'Percent Body Surface Area (BSA)', 'classes': [{'categories': [{'measurements': [{'value': '17.13', 'spread': '8.743', 'groupId': 'BG000'}, {'value': '15.84', 'spread': '7.888', 'groupId': 'BG001'}, {'value': '16.70', 'spread': '8.480', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of Affected BSA', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Eczema Area and Severity Index (EASI)', 'classes': [{'categories': [{'measurements': [{'value': '13.45', 'spread': '5.615', 'groupId': 'BG000'}, {'value': '13.09', 'spread': '4.689', 'groupId': 'BG001'}, {'value': '13.33', 'spread': '5.322', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-09', 'size': 7183091, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-13T18:12', 'hasProtocol': True}, {'date': '2023-02-17', 'size': 15994700, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-13T18:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator, study center staff, subject, and sponsor will be blinded to treatment assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Following a 30-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive once daily treatment with tapinarof cream, 1% or vehicle cream.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2023-03-23', 'completionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2021-08-27', 'resultsFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2021-08-27', 'dispFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-19', 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.', 'timeFrame': 'Baseline to Week 8', 'description': 'The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.\n\nStatistics are based on 100 imputed datasets.'}], 'secondaryOutcomes': [{'measure': 'Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.', 'timeFrame': 'Baseline to Week 8', 'description': 'The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.\n\nStatistics are based on 100 imputed datasets.'}, {'measure': 'Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8.', 'timeFrame': 'Baseline to Week 8', 'description': 'Assessment of percent body surface area (%BSA) is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% \\[10 handprints\\], upper extremities = 20% \\[20 handprints\\], trunk (including axillae and groin) = 30% \\[30 handprints\\], lower extremities, including buttocks, = 40% \\[40 handprints\\]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.'}, {'measure': 'Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.', 'timeFrame': 'Baseline to Week 8', 'description': 'The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.\n\nStatistics are based on 100 imputed datasets.'}, {'measure': 'Percent of Subjects ≥ 12 Years Old With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the Average Weekly PP-NRS From Baseline to Week 8.', 'timeFrame': 'Baseline to Week 8', 'description': 'The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.\n\nStatistics are based on 100 imputed datasets.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eczema', 'pediatric', 'tapinarof', 'phase 3', 'topical'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '38777187', 'type': 'RESULT', 'citation': 'Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.'}, {'pmid': '40696240', 'type': 'DERIVED', 'citation': 'Alexis AF, Kircik L, Chovatiya R, Rice ZP, Soong W, Bhutani T, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM, Armstrong AW. Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials. Dermatol Ther (Heidelb). 2025 Sep;15(9):2667-2682. doi: 10.1007/s13555-025-01489-w. Epub 2025 Jul 22.'}, {'pmid': '40600584', 'type': 'DERIVED', 'citation': 'Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.'}, {'pmid': '39799945', 'type': 'DERIVED', 'citation': 'Gold LS, Del Rosso J, Ehst BD, Zirwas MJ, Green LJ, Brown PM, Rubenstein DS, Piscitelli SC, Tallman AM. Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials. J Dermatolog Treat. 2025 Dec;36(1):2444489. doi: 10.1080/09546634.2024.2444489. Epub 2025 Jan 12.'}, {'pmid': '39777610', 'type': 'DERIVED', 'citation': 'Simpson EL, Hebert AA, Browning J, Serrao RT, Sofen H, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM. Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children. Dermatol Ther (Heidelb). 2025 Jan;15(1):111-124. doi: 10.1007/s13555-024-01318-6. Epub 2025 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.', 'detailedDescription': 'This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects ages 2 and above with clinical diagnosis of AD\n* Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA\n* A vIGA-AD score of ≥3 at screening and baseline\n* An EASI score of ≥6 at screening and baseline\n* Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old\n* Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods\n* Must not be pregnant\n* Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent\n\nExclusion Criteria:\n\n* Immunocompromised at screening\n* Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit\n* Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).\n* Screening total bilirubin \\> 1.5x ULN\n* Current or chronic history of liver disease\n* Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix\n* Subjects who would not be considered suitable for topical therapy\n* Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)\n* History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.\n* Pregnant or lactating females\n* History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation\n* Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)"}, 'identificationModule': {'nctId': 'NCT05032859', 'briefTitle': 'Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults', 'orgStudyIdInfo': {'id': 'DMVT-505-3102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tapinarof cream', 'description': 'tapinarof cream, 1%, applied topically once daily', 'interventionNames': ['Drug: tapinarof cream, 1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'vehicle cream', 'description': 'vehicle cream, applied topically once daily', 'interventionNames': ['Drug: vehicle cream']}], 'interventions': [{'name': 'tapinarof cream, 1%', 'type': 'DRUG', 'description': 'applied topically once daily', 'armGroupLabels': ['tapinarof cream']}, {'name': 'vehicle cream', 'type': 'DRUG', 'description': 'applied topically once daily', 'armGroupLabels': ['vehicle cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': 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