Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-03-03 @ 2:24 AM
Study NCT ID:
NCT03260595
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2017-08-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Day 29 for Cohort 1 and Day 36 for Cohort 2', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Crisaborole Ointment 2% and Vehicle', 'description': 'Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.", 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: Vehicle', 'description': "Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.", 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Application site coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohort 1: Skin Irritation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Crisaborole Ointment 2% and Vehicle', 'description': 'Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'title': 'Crisaborole ointment 2%', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Vehicle', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 3 to 4', 'description': 'The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation.', 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 2, as pre-specified in protocol.'}, {'type': 'PRIMARY', 'title': 'Cohort 2: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}, {'id': 'OG001', 'title': 'Cohort 2: Vehicle', 'description': "Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 36', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}, {'id': 'OG001', 'title': 'Cohort 2: Vehicle', 'description': "Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (Day 8)', 'description': "Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'PRIMARY', 'title': 'Cohort 2: Number of Participants With Laboratory Tests Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}, {'id': 'OG001', 'title': 'Cohort 2: Vehicle', 'description': "Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (Day 8)', 'description': 'Laboratory tests abnormalities included: hematology (haemoglobin\\[Hb\\], haematocrit and erythrocytes\\<0.8\\*lower limit of normal\\[LLN\\]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration \\<0.9\\*LLN and \\>1.1\\*upper limit of normal\\[ULN\\]; platelets \\<0.5\\*LLN and \\>1.75\\*ULN; leukocytes \\<0.6\\*LLN and \\>1.5\\*ULN; lymphocytes/leukocytes\\[%\\], neutrophils/leukocytes\\[%\\] \\<0.8\\*LLN and \\>1.2\\*ULN; basophils/leukocytes\\[%\\], eosinophils/leukocytes\\[%\\], monocytes/leukocytes\\[% \\]\\>1.2\\*ULN); clinical chemistry(bilirubin\\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase\\>3.0\\*ULN; protein and albumin\\<0.8\\*LLN and \\>1.2\\*ULN; urea nitrogen and creatinine \\>1.3\\*ULN; urate\\>1.2\\*ULN; sodium \\<0.95\\*LLN and \\>1.05\\*ULN; potassium, chloride and calcium \\<0.9\\*LLN and \\>1.1\\*ULN; fasting glucose \\<0.6\\*LLN and \\>1.5\\*ULN); and urinalysis (pH \\<4.5 and \\>8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase \\>=1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'PRIMARY', 'title': 'Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}, {'id': 'OG001', 'title': 'Cohort 2: Vehicle', 'description': "Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (Day 8)', 'description': "Criteria for clinically significant ECG abnormalities included: QT interval \\>=500 milliseconds (msec); QT interval corrected using the Fridericia's formula (QTcF) \\>=450 msec to \\<480 msec, \\>=480 msec and \\>=500 msec; increase from baseline in QTcF interval \\>=30 msec to \\<60 msec and \\>=60 msec.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Crisaborole Ointment 2% and Vehicle', 'description': 'Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 29', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Maximum Observed Plasma Concentration (Cmax) of Crisaborole and Its Identified Main Oxidative Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'Crisaborole: Day 1', 'categories': [{'measurements': [{'value': '163.7', 'spread': '71', 'groupId': 'OG000'}]}]}, {'title': 'Crisaborole: Day 8', 'categories': [{'measurements': [{'value': '164.9', 'spread': '56', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 1', 'categories': [{'measurements': [{'value': '94.97', 'spread': '75', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 8', 'categories': [{'measurements': [{'value': '68.83', 'spread': '59', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 1', 'categories': [{'measurements': [{'value': '3064', 'spread': '97', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 8', 'categories': [{'measurements': [{'value': '8080', 'spread': '71', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crisaborole and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'Crisaborole: Day 1', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '3.00'}]}]}, {'title': 'Crisaborole: Day 8', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '3.00'}]}]}, {'title': 'AN7602: Day 1', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '3.00'}]}]}, {'title': 'AN7602: Day 8', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '3.00'}]}]}, {'title': 'AN8323: Day 1', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '12.0'}]}]}, {'title': 'AN8323: Day 8', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Measurable Concentration (AUClast) of Crisaborole and Its Identified Main Oxidative Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'Crisaborole: Day 1', 'categories': [{'measurements': [{'value': '1171', 'spread': '60', 'groupId': 'OG000'}]}]}, {'title': 'Crisaborole: Day 8', 'categories': [{'measurements': [{'value': '1527', 'spread': '48', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 1', 'categories': [{'measurements': [{'value': '601.9', 'spread': '60', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 8', 'categories': [{'measurements': [{'value': '565.5', 'spread': '44', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 1', 'categories': [{'measurements': [{'value': '57560', 'spread': '84', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 8', 'categories': [{'measurements': [{'value': '169100', 'spread': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.', 'unitOfMeasure': 'hours*nanograms per milliliter(hr*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hours Post-Dose (AUC24) of Crisaborole and Its Identified Main Oxidative Metabolites (AN7602 and AN8323)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'Crisaborole: Day 1', 'categories': [{'measurements': [{'value': '1171', 'spread': '60', 'groupId': 'OG000'}]}]}, {'title': 'Crisaborole: Day 8', 'categories': [{'measurements': [{'value': '1527', 'spread': '48', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 1', 'categories': [{'measurements': [{'value': '601.9', 'spread': '60', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 8', 'categories': [{'measurements': [{'value': '565.5', 'spread': '44', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 1', 'categories': [{'measurements': [{'value': '57560', 'spread': '84', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 8', 'categories': [{'measurements': [{'value': '169100', 'spread': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Tau (12 Hours Dosing Interval) (AUCtau) of Crisaborole and Its Identified Main Oxidative Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'Crisaborole: Day 1', 'categories': [{'measurements': [{'value': '928.9', 'spread': '65', 'groupId': 'OG000'}]}]}, {'title': 'Crisaborole: Day 8', 'categories': [{'measurements': [{'value': '1123', 'spread': '51', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 1', 'categories': [{'measurements': [{'value': '500.4', 'spread': '66', 'groupId': 'OG000'}]}]}, {'title': 'AN7602: Day 8', 'categories': [{'measurements': [{'value': '434.9', 'spread': '50', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 1', 'categories': [{'measurements': [{'value': '29360', 'spread': '92', 'groupId': 'OG000'}]}]}, {'title': 'AN8323: Day 8', 'categories': [{'measurements': [{'value': '90360', 'spread': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Accumulation Ratio for Cmax (Rac [Cmax]) of Crisaborole and Its Identified Main Oxidative Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'Crisaborole', 'categories': [{'measurements': [{'value': '1.007', 'spread': '32', 'groupId': 'OG000'}]}]}, {'title': 'AN7602', 'categories': [{'measurements': [{'value': '0.7247', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': 'AN8323', 'categories': [{'measurements': [{'value': '2.638', 'spread': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Accumulation Ratio for AUCtau (Rac [AUCtau]) of Crisaborole and Its Identified Main Oxidative Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'classes': [{'title': 'Crisaborole', 'categories': [{'measurements': [{'value': '1.209', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'AN7602', 'categories': [{'measurements': [{'value': '0.8688', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'AN8323', 'categories': [{'measurements': [{'value': '3.080', 'spread': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Crisaborole Ointment 2% and Vehicle', 'description': 'Crisaborole ointment 2 percent (%) and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.'}, {'id': 'FG001', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is atopic dermatitis \\[AD\\]-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}, {'id': 'FG002', 'title': 'Cohort 2: Vehicle', 'description': "Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Crisaborole Ointment 2% and Vehicle', 'description': 'Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.'}, {'id': 'BG001', 'title': 'Cohort 2: Crisaborole Ointment 2%', 'description': "Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}, {'id': 'BG002', 'title': 'Cohort 2: Vehicle', 'description': "Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '5.66', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '11.28', 'groupId': 'BG001'}, {'value': '23.5', 'spread': '4.95', 'groupId': 'BG002'}, {'value': '28.8', 'spread': '8.72', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis population included all participants who received at least one dose of study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-14', 'size': 3118635, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-26T12:45', 'hasProtocol': True}, {'date': '2017-11-30', 'size': 1309921, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-26T12:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2017-08-09', 'resultsFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-26', 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: Skin Irritation Index', 'timeFrame': 'Day 3 to 4', 'description': 'The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation.'}, {'measure': 'Cohort 2: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Day 36', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.'}, {'measure': 'Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline up to end of treatment (Day 8)', 'description': "Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion."}, {'measure': 'Cohort 2: Number of Participants With Laboratory Tests Abnormalities', 'timeFrame': 'Baseline up to end of treatment (Day 8)', 'description': 'Laboratory tests abnormalities included: hematology (haemoglobin\\[Hb\\], haematocrit and erythrocytes\\<0.8\\*lower limit of normal\\[LLN\\]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration \\<0.9\\*LLN and \\>1.1\\*upper limit of normal\\[ULN\\]; platelets \\<0.5\\*LLN and \\>1.75\\*ULN; leukocytes \\<0.6\\*LLN and \\>1.5\\*ULN; lymphocytes/leukocytes\\[%\\], neutrophils/leukocytes\\[%\\] \\<0.8\\*LLN and \\>1.2\\*ULN; basophils/leukocytes\\[%\\], eosinophils/leukocytes\\[%\\], monocytes/leukocytes\\[% \\]\\>1.2\\*ULN); clinical chemistry(bilirubin\\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase\\>3.0\\*ULN; protein and albumin\\<0.8\\*LLN and \\>1.2\\*ULN; urea nitrogen and creatinine \\>1.3\\*ULN; urate\\>1.2\\*ULN; sodium \\<0.95\\*LLN and \\>1.05\\*ULN; potassium, chloride and calcium \\<0.9\\*LLN and \\>1.1\\*ULN; fasting glucose \\<0.6\\*LLN and \\>1.5\\*ULN); and urinalysis (pH \\<4.5 and \\>8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase \\>=1).'}, {'measure': 'Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to end of treatment (Day 8)', 'description': "Criteria for clinically significant ECG abnormalities included: QT interval \\>=500 milliseconds (msec); QT interval corrected using the Fridericia's formula (QTcF) \\>=450 msec to \\<480 msec, \\>=480 msec and \\>=500 msec; increase from baseline in QTcF interval \\>=30 msec to \\<60 msec and \\>=60 msec."}], 'secondaryOutcomes': [{'measure': 'Cohort 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Day 29', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.'}, {'measure': 'Cohort 2: Maximum Observed Plasma Concentration (Cmax) of Crisaborole and Its Identified Main Oxidative Metabolites', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.'}, {'measure': 'Cohort 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crisaborole and Its Metabolites', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.'}, {'measure': 'Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Measurable Concentration (AUClast) of Crisaborole and Its Identified Main Oxidative Metabolites', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.'}, {'measure': 'Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hours Post-Dose (AUC24) of Crisaborole and Its Identified Main Oxidative Metabolites (AN7602 and AN8323)', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.'}, {'measure': 'Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Tau (12 Hours Dosing Interval) (AUCtau) of Crisaborole and Its Identified Main Oxidative Metabolites', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours.'}, {'measure': 'Cohort 2: Accumulation Ratio for Cmax (Rac [Cmax]) of Crisaborole and Its Identified Main Oxidative Metabolites', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites.'}, {'measure': 'Cohort 2: Accumulation Ratio for AUCtau (Rac [AUCtau]) of Crisaborole and Its Identified Main Oxidative Metabolites', 'timeFrame': 'Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8', 'description': 'AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C3291029&StudyName=A+Phase+1%2C+Single-center%2C+Randomized%2C+Vehicle-controlled%2C+Parallel-cohort+Study+Of+Crisaborole+Ointment+2%25+To+Evaluate+The+Skin+Irritation+Potential+In+Adult+Japanese+Healthy+Subjects%2C+And+To+Evaluate+The+Safety%2C+Tolerability+And+Pharmacokinetics+In+Adult+Japanese+Subjects+With+Mild+To+Moderate+Atopic+Dermatitis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nCohort 1\n\n1. Healthy male Japanese subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.\n2. Healthy skin on which reddening can be easily recognized in the area of the test fields.\n\nCohort 2\n\n1. Male or female Japanese subjects aged 20 years to 55 years (inclusive) at the time of screening, and in generally good health except for AD.\n2. Diagnosis of AD based on the criteria of Hanifin and Rajka (1980).\n3. Has at least 25% Treatable %BSA on Day 1 (excluding the scalp and designated venous access areas).\n4. Has an Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.\n\nExclusion Criteria:\n\nCohort 1\n\n1. Subjects who have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.\n2. Subjects who have psoriasis and/or active AD/eczema.\n3. Subjects who have a history of AD.\n4. Subjects who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.\n5. Known sensitivity to any of the components of the investigational products.\n6. History of the rash to the adhesive plaster, contact dermatitis to metal, or cosmetic and household articles.\n\nCohort 2\n\n1. Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent dermatological conditions other than AD), significant physical examination or laboratory findings that may interfere with study objectives, in the Investigator's opinion.\n2. Has unstable AD or a consistent requirement for strong to strongest potency topical corticosteroids to manage AD signs and symptoms.\n3. Has a significant active systemic or localized infection, including known actively infected AD.\n4. Has a history or evidence of clinically significant or severe allergies (eg, seasonal, pet dander, environmental, food) requiring acute or chronic treatment.\n5. Has recent or anticipated concomitant use of topical or systemic therapies that might alter the course of AD.\n6. Has a history of recent (within 4 weeks of Day 1) sunbathing, tanning bed use, or ultraviolet (UV) light B therapy (UVB) or psoralen plus UVA \\[PUVA\\]).\n7. Has a known sensitivity to any of the components of crisaborole ointment 2%.\n8. Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product."}, 'identificationModule': {'nctId': 'NCT03260595', 'briefTitle': 'A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Single-center, Randomized, Vehicle-controlled, Parallel-cohort Study Of Crisaborole Ointment 2% To Evaluate The Skin Irritation Potential In Adult Japanese Healthy Subjects, And To Evaluate The Safety, Tolerability And Pharmacokinetics In Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'C3291029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crisaborole ointment 2%', 'interventionNames': ['Drug: Crisaborole ointment 2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Crisaborole ointment 2%', 'type': 'DRUG', 'description': 'Crisaborole ointment 2%', 'armGroupLabels': ['Crisaborole ointment 2%']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Vehicle', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '532-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OPHAC Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}