Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 3:50 AM
Study NCT ID:
NCT02340169
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2014-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003899', 'term': 'Desoximetasone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'natalie.yantovskiy@taro.com', 'phone': '+1 914-345-9001', 'title': 'Senior Director, Clinical Research', 'organization': 'Taro Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For each subject Adverse Events were collected during their 28 day treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Topicort® Topical Spray, 0.25%', 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days\n\nTopicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 0, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '12 to 17 Years of Age'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': '6 to 11 Years of age'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': '2 to 5 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adrenal suppression rates in the evaluable population were 35% (21 out of 60), 43.3% (13 out of 30) and 20% (2 out of 10) in Cohorts 1, 2 a nd 3, respectively.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria:\n\n* their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\\< basal + 7)\n* the post stimulation level is ≤ 18 mcg/100 ml', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Topicort® Topical Spray, 0.25%', 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days\n\nTopicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'The total number of subjects experiencing adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cpre-ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topicort® Topical Spray, 0.25% - Cohort 1', 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days\n\nTopicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days'}, {'id': 'OG001', 'title': 'Topicort® Topical Spray, 0.25% - Cohort 2', 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days\n\nTopicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '527.64', 'spread': '574.47', 'groupId': 'OG000'}, {'value': '475.41', 'spread': '215.66', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 Days', 'description': 'Concentration prior to dosing at steady state.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK sampling from was taken from a subset of patients in cohorts 1 and 2'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topicort® Topical Spray, 0.25%', 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days\n\nTopicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'Cohort 1 12-17 Years of Age', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'Cohort 2 6 to 11 Years of Age', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Cohort 3 2 to 5 Years of Age', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}]}], 'recruitmentDetails': 'The first patient enrolled in the study 23 January 2015. The last patient completed the study 22 November 2019. The Patients were enrolled in 3 cohorts. Cohort 1, 12 to 17 years and 11 months, Cohort 2, 6 year to 11 and 11 Months and Cohort 3, 2 years to 5 years and 11 months. In total 129 subjects were enrolled across 7 Investigator sites.', 'preAssignmentDetails': 'Prior to the Protocol Amendment if a subject was found to have an abnormal adrenal function test after the baseline Cortisol Response test the subject was notified to discontinue the drug and follow up with the Investigator. After the protocol amendment a screening visit was added so that subjects with abnormal tests would not be randomized to study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Topicort® Topical Spray, 0.25%', 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days\n\nTopicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Cohort 1 - 12 to 17 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}, {'title': 'Cohort 2- 6 to 11 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Cohort 3 - 2 to 5 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Cohort 1 -12 to 17 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'Cohort 2 - 6 to 11 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Cohort 3- 2 to 5 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'the participants were analyzed in three separate cohorts'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '126', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Panama', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'El Salvador', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypothalamic-Pituitary-Adrenal (HPA) Axis Function', 'classes': [{'title': 'Cohort 1 - 12 to 17 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Cohort 2 - 6 to 11 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Cohort 3 - 2 to 5 years of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HPA axis suppression was measured in the 100 evaluable subjects.', 'unitOfMeasure': 'Participants', 'populationDescription': 'HPA Axis suppression was measured in the 100 evaluable subjects.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-06', 'size': 446290, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-02T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2014-12-28', 'resultsFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-28', 'studyFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test', 'timeFrame': '28 days', 'description': 'A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria:\n\n* their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\\< basal + 7)\n* the post stimulation level is ≤ 18 mcg/100 ml'}], 'secondaryOutcomes': [{'measure': 'Adverse Event', 'timeFrame': '28 days', 'description': 'The total number of subjects experiencing adverse events.'}, {'measure': 'Cpre-ss', 'timeFrame': '28 Days', 'description': 'Concentration prior to dosing at steady state.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.', 'detailedDescription': 'An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative\n* Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)\n* Physicians Global Assessment score of 3 or 4 at baseline\n\nExclusion Criteria:\n\n* Has other dermatological conditions that may interfere with clinical assessments\n* Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results\n* History of an adverse reaction to Cortrosyn™ or similar test reagents\n* Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation"}, 'identificationModule': {'nctId': 'NCT02340169', 'briefTitle': 'Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.', 'orgStudyIdInfo': {'id': 'DSXS-1303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topicort® Topical Spray, 0.25%', 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days', 'interventionNames': ['Drug: Topicort® (desoximetasone) Topical Spray, 0.25%']}], 'interventions': [{'name': 'Topicort® (desoximetasone) Topical Spray, 0.25%', 'type': 'DRUG', 'otherNames': ['desoximetasone'], 'description': 'Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days', 'armGroupLabels': ['Topicort® Topical Spray, 0.25%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10532', 'city': 'Hawthorne', 'state': 'New York', 'country': 'United States', 'facility': 'Taro Pharmaceuticals USA Inc.', 'geoPoint': {'lat': 41.10732, 'lon': -73.79597}}], 'overallOfficials': [{'name': 'Novum Pharmaceutical Research Services', 'role': 'STUDY_CHAIR', 'affiliation': 'http://www.novumprs.com/contact'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}