Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT05186805
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2021-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
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': 'Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35', 'eventGroups': [{'id': 'EG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 8, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pustule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tranaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Experienced an AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Experienced an SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35', 'description': 'Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Alanine aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '10.80', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '52.95', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Albumin (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.72', 'groupId': 'OG000'}]}]}, {'title': 'Protein (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.20', 'groupId': 'OG000'}]}]}, {'title': 'Ery. mean corpuscular HGB Concentration (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '7.68', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '7.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Bicarbonate (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.16', 'groupId': 'OG000'}]}]}, {'title': 'Calcium (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.0846', 'groupId': 'OG000'}]}]}, {'title': 'Chloride (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.99', 'groupId': 'OG000'}]}]}, {'title': 'Glucose (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.819', 'groupId': 'OG000'}]}]}, {'title': 'Potassium (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.532', 'groupId': 'OG000'}]}]}, {'title': 'Sodium (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.98', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.989', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (Umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Bilirubin (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '3.700', 'groupId': 'OG000'}]}]}, {'title': 'Enzymatic Creatinine (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '7.66', 'groupId': 'OG000'}]}]}, {'title': 'Urate (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '52.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance', 'unitOfMeasure': 'Umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (10^9 Cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Basophils (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.048', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.419', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '2.451', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.095', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.175', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '2.124', 'groupId': 'OG000'}]}]}, {'title': 'Platelets (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-34.8', 'spread': '95.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Basophils/Total cells (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.343', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils/Total cells (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '4.606', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes/Total cells (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '11.023', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes/Total cells (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '2.662', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/Total cells (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '12.693', 'groupId': 'OG000'}]}]}, {'title': 'Reticulocytes/Erythrocytes (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.377', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance', 'unitOfMeasure': '% of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (pg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.787', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Ery. mean corpuscular hemoglobin laboratory values was assessed for clinical relevance', 'unitOfMeasure': 'pg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (fL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'spread': '1.973', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Ery. mean corpuscular volume laboratory values was assessed for clinical relevance', 'unitOfMeasure': 'fL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (10^12 Cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.055', 'spread': '0.2481', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Erythrocytes laboratory values was assessed for clinical relevance', 'unitOfMeasure': '10^12 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Laboratory Values (L/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0228', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Hematocrit laboratory values was assessed for clinical relevance', 'unitOfMeasure': 'L/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Mean Change in Local Tolerability Scale (LTS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale. 0 indicates no irritation and 4 indicates Very Severe irritation.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Tapinarof Plasma PK Parameters on Day 1: AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4690', 'spread': '5600', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Tapinarof Plasma PK Parameters on Day 1: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2440', 'spread': '3900', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Tapinarof Plasma PK Parameters on Day 1: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.37', 'spread': '1.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Tapinarof Plasma Concentration: Cτ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1330', 'spread': '3780', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The Cτ is a pharmacokinetic parameter that is the last quantifiable concentration determined directly from individual concentration-time data', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Signs (Beats/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '14.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in pulse vital signs was assessed for clinical relevance', 'unitOfMeasure': 'Beats/Min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Signs (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily'}], 'classes': [{'title': 'Systolic Blood Pressure (mmHg)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '8.78', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure (mmHg)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '6.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Blood Pressure vital signs was assessed for clinical relevance', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Signs (C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.402', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Temperature vital signs was assessed for clinical relevance', 'unitOfMeasure': 'degrees C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'title': '+4 = worsened by 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '+3 = worsened by 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '+2 = worsened by 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '+1 = worsened by 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '0 - no change', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '-1 = improved by 1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '-2 = improved by 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '-3 = improved by 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '-4 = improved by 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have a Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Score of Almost Clear (0 or 1) and at Least a 2-grade Reduction From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.16', 'spread': '9.742', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed cases'}, {'type': 'SECONDARY', 'title': 'Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-53.38', 'spread': '38.337', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.', 'unitOfMeasure': '% change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed cases'}, {'type': 'SECONDARY', 'title': 'Mean Change in Percent of Total Body Surface Area (%BSA) Affected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.06', 'spread': '18.789', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': "The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.", 'unitOfMeasure': 'percentage of BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed cases'}, {'type': 'SECONDARY', 'title': 'Percent Change in Percent of Total Body Surface Area (%BSA) Affected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.40', 'spread': '41.3000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': "The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.", 'unitOfMeasure': '% change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed cases'}, {'type': 'SECONDARY', 'title': 'Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-85.15', 'spread': '65.848', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': "The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting (0 indicates no inflammatory signs of atopic dermatitis and 4 indicates disease is widespread). The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. %BSA is a static assessment made without reference to previous scores and will be evaluated 0-100%. The computation is referenced below, and no unit is applicable for this outcome measure. A negative change indicates improvement in disease.\n\n\\[Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)\\]", 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-62.77', 'spread': '35.290', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': "The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent. The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.\n\nComputation: Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)", 'unitOfMeasure': '% change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.155', 'spread': '2.4558', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'description': 'The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed Cases'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) Score ≥4 Who Achieved ≥4-point Reduction in PP-NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'classes': [{'categories': [{'title': 'Achieved ≥ 4-Point Reduction from Baseline in the Average Weekly PP-NRS Score', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Failure to Achieve a ≥ 4-point Reduction from Baseline in the Average Weekly PP-NRS Score', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', 'description': 'The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, Observed cases, subjects with baseline PP-NRS score ≥4'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants from the DMVT-505-2104 study had the option to participate in the open label extension study (DMVT-505-3103, NCT05142774).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tapinarof Cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily\n\nTapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '4.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Validated Investigator Global Assessment for Atopic Dermatitis', 'classes': [{'categories': [{'title': '0 - Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '1 - Almost Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '2 - Mild', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '3 - Moderate', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '4 - Severe', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-25', 'size': 5718245, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-13T18:01', 'hasProtocol': True}, {'date': '2022-09-08', 'size': 14177373, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-13T18:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2023-01-11', 'completionDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2021-11-08', 'resultsFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2021-12-23', 'dispFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-02', 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35', 'description': 'Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs).'}, {'measure': 'Change From Baseline in Laboratory Values (U/L)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (g/L)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (mmol/L)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (Umol/L)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (10^9 Cells/L)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (%)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (pg)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Ery. mean corpuscular hemoglobin laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (fL)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Ery. mean corpuscular volume laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (10^12 Cells/L)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Erythrocytes laboratory values was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Laboratory Values (L/L)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Hematocrit laboratory values was assessed for clinical relevance'}, {'measure': 'Mean Change in Local Tolerability Scale (LTS)', 'timeFrame': 'Baseline to Day 28', 'description': 'Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale. 0 indicates no irritation and 4 indicates Very Severe irritation.'}, {'measure': 'Tapinarof Plasma PK Parameters on Day 1: AUC0-τ', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.'}, {'measure': 'Tapinarof Plasma PK Parameters on Day 1: Cmax', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.'}, {'measure': 'Tapinarof Plasma PK Parameters on Day 1: Tmax', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.'}, {'measure': 'Tapinarof Plasma Concentration: Cτ', 'timeFrame': 'Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)', 'description': 'The Cτ is a pharmacokinetic parameter that is the last quantifiable concentration determined directly from individual concentration-time data'}, {'measure': 'Change From Baseline in Vital Signs (Beats/Min)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in pulse vital signs was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Vital Signs (mmHg)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Blood Pressure vital signs was assessed for clinical relevance'}, {'measure': 'Change From Baseline in Vital Signs (C)', 'timeFrame': 'Baseline to Day 28', 'description': 'Change in Temperature vital signs was assessed for clinical relevance'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)', 'timeFrame': 'Baseline to Day 28', '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.'}, {'measure': 'Number of Subjects Who Have a Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Score of Almost Clear (0 or 1) and at Least a 2-grade Reduction From Baseline', 'timeFrame': 'Baseline to Day 28', '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.'}, {'measure': 'Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline to Day 28', '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.'}, {'measure': 'Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.'}, {'measure': 'Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.'}, {'measure': 'Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.'}, {'measure': 'Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28', 'timeFrame': 'Baseline to Day 28', 'description': 'The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.'}, {'measure': 'Mean Change in Percent of Total Body Surface Area (%BSA) Affected', 'timeFrame': 'Baseline to Day 28', 'description': "The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores."}, {'measure': 'Percent Change in Percent of Total Body Surface Area (%BSA) Affected', 'timeFrame': 'Baseline to Day 28', 'description': "The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores."}, {'measure': 'Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values', 'timeFrame': 'Baseline to Day 28', 'description': "The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting (0 indicates no inflammatory signs of atopic dermatitis and 4 indicates disease is widespread). The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. %BSA is a static assessment made without reference to previous scores and will be evaluated 0-100%. The computation is referenced below, and no unit is applicable for this outcome measure. A negative change indicates improvement in disease.\n\n\\[Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)\\]"}, {'measure': 'Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values', 'timeFrame': 'Baseline to Day 28', 'description': "The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent. The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.\n\nComputation: Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)"}, {'measure': 'Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score', 'timeFrame': 'Baseline to Day 28', 'description': 'The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.'}, {'measure': 'Proportion of Subjects With a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) Score ≥4 Who Achieved ≥4-point Reduction in PP-NRS Score', 'timeFrame': 'Baseline to Day 28', 'description': 'The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eczema', 'pediatric', 'tapinarof', 'phase 2', 'topical'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '26634191', 'type': 'BACKGROUND', 'citation': 'Bashaw ED, Tran DC, Shukla CG, Liu X. Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products. Ther Innov Regul Sci. 2015 Jan;49(1):108-115. doi: 10.1177/2168479014539157. Epub 2014 Jun 27.'}, {'pmid': '18385500', 'type': 'BACKGROUND', 'citation': 'Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Cappon GD and Hurtt ME. Developmental toxicity of the kidney. In: Kapp RW and Yyl L, editors. Reproductive Toxicology, Target Organ Series, 3rd edition. New York:Informa Healthcare, 2010:193-204.'}, {'pmid': '15916563', 'type': 'BACKGROUND', 'citation': 'Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x.'}, {'type': 'BACKGROUND', 'citation': 'Frazier KS and Seely JC. Urinary system. In: Sahota PS, Popp JA, Hardisty JF and Gopinath C, editors. Toxicologic Pathology. Nonclinical Safety Assessment. CRC Press, 2013:421-84.'}, {'pmid': '31683543', 'type': 'BACKGROUND', 'citation': 'Furue M, Hashimoto-Hachiya A, Tsuji G. Aryl Hydrocarbon Receptor in Atopic Dermatitis and Psoriasis. Int J Mol Sci. 2019 Oct 31;20(21):5424. doi: 10.3390/ijms20215424.'}, {'type': 'BACKGROUND', 'citation': 'Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermato-Venereologica Supplementum. 1980;92:44-7.'}, {'pmid': '11168575', 'type': 'BACKGROUND', 'citation': 'Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.'}, {'pmid': '9699737', 'type': 'BACKGROUND', 'citation': 'Kalia YN, Nonato LB, Lund CH, Guy RH. Development of skin barrier function in premature infants. J Invest Dermatol. 1998 Aug;111(2):320-6. doi: 10.1046/j.1523-1747.1998.00289.x.'}, {'pmid': '16893440', 'type': 'BACKGROUND', 'citation': 'Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006 Aug;60(8):984-92. doi: 10.1111/j.1742-1241.2006.01047.x.'}, {'pmid': '18200056', 'type': 'BACKGROUND', 'citation': 'Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Invest Dermatol. 2008 Jul;128(7):1728-36. doi: 10.1038/sj.jid.5701239. Epub 2008 Jan 17.'}, {'pmid': '30554600', 'type': 'BACKGROUND', 'citation': 'Peppers J, Paller AS, Maeda-Chubachi T, Wu S, Robbins K, Gallagher K, Kraus JE. A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. J Am Acad Dermatol. 2019 Jan;80(1):89-98.e3. doi: 10.1016/j.jaad.2018.06.047. Epub 2018 Jul 3.'}, {'pmid': '28595996', 'type': 'BACKGROUND', 'citation': 'Smith SH, Jayawickreme C, Rickard DJ, Nicodeme E, Bui T, Simmons C, Coquery CM, Neil J, Pryor WM, Mayhew D, Rajpal DK, Creech K, Furst S, Lee J, Wu D, Rastinejad F, Willson TM, Viviani F, Morris DC, Moore JT, Cote-Sierra J. Tapinarof Is a Natural AhR Agonist that Resolves Skin Inflammation in Mice and Humans. J Invest Dermatol. 2017 Oct;137(10):2110-2119. doi: 10.1016/j.jid.2017.05.004. Epub 2017 Jun 6.'}, {'pmid': '12866702', 'type': 'BACKGROUND', 'citation': 'Zoetis T, Hurtt ME. Species comparison of anatomical and functional renal development. Birth Defects Res B Dev Reprod Toxicol. 2003 Apr;68(2):111-20. doi: 10.1002/bdrb.10013. No abstract available.'}, {'pmid': '40126804', 'type': 'DERIVED', 'citation': 'Paller AS, Hebert AA, Gonzalez ME, Butners V, Fitzgerald N, Tabolt G, Rubenstein DS, Piscitelli SC. Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis. Am J Clin Dermatol. 2025 May;26(3):449-456. doi: 10.1007/s40257-025-00929-9. Epub 2025 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis', 'detailedDescription': 'This is a 4-week open-label study in which subjects will be assigned to receive tapinarof cream, 1% once daily for 4 weeks. At the end of the 4-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'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old\n* BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy.\n* vIGA-AD score of ≥ 3 at screening and baseline (pre-dose)\n* Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study\n* Capable of giving written informed consent\n* Negative pregnancy test at Baseline (Day 1)\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': 'NCT05186805', 'briefTitle': 'Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Open Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'DMVT-505-2104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tapinarof cream', 'description': 'Tapinarof (DMVT-505) cream, 1% applied topically once daily', 'interventionNames': ['Drug: Tapinarof cream, 1%']}], 'interventions': [{'name': 'Tapinarof cream, 1%', 'type': 'DRUG', 'otherNames': ['DMVT-505'], 'description': 'Tapinarof cream, 1% applied topically once daily', 'armGroupLabels': ['tapinarof cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91320', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '29445', 'city': 'Summerville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 33.0185, 'lon': -80.17565}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'T3A 2N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Dermavant Investigative Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Diana Villalobos', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dermavant Sciences, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}