Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-11 @ 2:56 PM
Study NCT ID:
NCT03179605
Status:
TERMINATED
Last Update Posted:
2024-03-07
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002990', 'term': 'Clobetasol'}], 'ancestors': [{'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'b.babilon@prosoftclinical.com', 'phone': '4843202068', 'title': 'Robert Babilon President', 'organization': 'Prosoft Clinical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination due to low enrollment with completion of 12 to 16.9 years old group only; the planned 6 to 11.9 years of age did not enroll.'}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'Adverse events were collected at every visit (except Screening) by spontaneous reports from subjects and legal guardian, either verbal or recorded in the subject diary, by directed questioning of subjects and legal guardian, and by observation.', 'eventGroups': [{'id': 'EG000', 'title': 'DFD-06 Cream', 'description': 'This is a single arm, open label study and there will be no reference or control product used in this study\n\nDFD06: Apply twice per day for 15 days', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 8, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'HPA Axis Suppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Application Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Application Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vein collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With HPA Axis Suppression at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DFD-06 Cream', 'description': 'This is a single arm, open label study and there will be no reference or control product used in this study\n\nDFD06: Apply twice per day for 15 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15', 'description': 'The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable population included those subjects in the Safety population who had both Screening and Day 15 serum cortisol data (pre- and post-cosyntropin stimulation) and had a normal response to Screening Cosyntropin Stimulation Test with a 30-minute post-stimulation cortisol level of \\> 18 μg/dL and applied at least 80% of expected (29) applications'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement in IGA Grade From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DFD-06 Cream', 'description': 'This is a single arm, open label study and there will be no reference or control product used in this study\n\nDFD06: Apply twice per day for 15 days'}], 'classes': [{'title': 'Day 8 1-point improvement in IGA', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 2-point improvement in IGA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 1 point improvement in IGA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 2-point improvement in IGA', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 3-point improvement in IGA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 15', 'description': 'Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable population included those subjects in the Safety population who had both Screening and Day 15 serum cortisol data (pre- and post-cosyntropin stimulation) and had a normal response to Screening Cosyntropin Stimulation Test with a 30-minute post-stimulation cortisol level of \\> 18 μg/dL and applied at least 80% of expected (29) applications'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Clobetasol Propionate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DFD-06 Cream', 'description': 'This is a single arm, open label study and there will be no reference or control product used in this study\n\nDFD06: Apply twice per day for 15 days'}], 'classes': [{'title': '0 hour clobetasol plasma level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.486', 'spread': '48.35', 'groupId': 'OG000'}]}]}, {'title': '1 hour clobetasol plasma level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.370', 'spread': '32.55', 'groupId': 'OG000'}]}]}, {'title': '3 hour clobetasol plasma level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.250', 'spread': '41.93', 'groupId': 'OG000'}]}]}, {'title': '6 hour clobetasol plasma level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.143', 'spread': '27.32', 'groupId': 'OG000'}]}]}, {'title': 'Average of 1, 3 and 6 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.47', 'spread': '32.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 0 hour, 1 hour, 3 hours, 6 hours after application', 'description': 'Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable population included those subjects in the Safety population who had both Screening and Day 15 serum cortisol data (pre- and post-cosyntropin stimulation) and had a normal response to Screening Cosyntropin Stimulation Test with a 30-minute post-stimulation cortisol level of \\> 18 μg/dL and applied at least 80% of expected (29) applications.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DFD-06 Cream', 'description': 'This is a single arm, open label study and there will be no reference or control product used in this study\n\nDFD06: Apply twice per day for 15 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Normal response to cosyntropin stimulation defined as a Screening Cosyntropin Stimulation Test (CST) with a 30-minute post-stimulation cortisol level of \\> 18 ug/dL.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DFD-06 Cream', 'description': 'This is a single arm, open label study and there will be no reference or control product used in this study\n\nDFD06: Apply twice per day for 15 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '1.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', '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': [{'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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Investigator Global Assessment', 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Investigator Global Assessment of psoriasis on a scale of 0 to 5. 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent Body Surface Area Affected', 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '24'}]}]}], 'paramType': 'MEAN', 'description': 'Psoriasis \\>= 10% body surface area required for enrollment', 'unitOfMeasure': 'percent body surface area', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-26', 'size': 1392870, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-05T09:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Difficulty in enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2017-05-12', 'resultsFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-05', 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With HPA Axis Suppression at Day 15', 'timeFrame': 'Day 15', 'description': 'The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Improvement in IGA Grade From Baseline', 'timeFrame': 'Baseline up to Day 15', 'description': 'Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics.'}, {'measure': 'Plasma Concentration of Clobetasol Propionate', 'timeFrame': 'Day 15 0 hour, 1 hour, 3 hours, 6 hours after application', 'description': 'Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the potential of DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.', 'detailedDescription': 'This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). An attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. DFD-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects and the parent or legal guardian understand the study procedures and agree to participate by giving assent and written informed consent, respectively. Subject's parent or legal guardian must be willing to authorize use and disclosure of protected health information collected for the study.\n* Subjects must be at least 6 years and not more than 16.9 years of age, with body weight greater than or equal to 45 pounds at Screening.\n* Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.\n* Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.\n* Subjects must have an Investigator Global Assessment (IGA) grade of at least 3 (moderate) at the Baseline Visit.\n\nExclusion Criteria:\n\n* Subject has a current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.\n* Subject has a history of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.\n* Subject has received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.\n* Subject has a history or presence of intracranial hypertension.\n* Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease"}, 'identificationModule': {'nctId': 'NCT03179605', 'briefTitle': 'Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06', 'organization': {'class': 'INDUSTRY', 'fullName': 'Primus Pharmaceuticals'}, 'officialTitle': 'An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'DFD-06-CD-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DFD-06 Cream', 'description': 'This is a single arm, open label study and there will be no reference or control product used in this study', 'interventionNames': ['Drug: DFD06']}], 'interventions': [{'name': 'DFD06', 'type': 'DRUG', 'otherNames': ['clobetasol propionate, Impoyz Cream'], 'description': 'Apply twice per day for 15 days', 'armGroupLabels': ['DFD-06 Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93637', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': 'Site 104', 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Site 108', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '33010', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site 102', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 109', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site 107', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site 103', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68522', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site 101', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Site 106', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '99203', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Site 105', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Primus Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Prosoft Clinical', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}