Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-26 @ 7:03 PM
Study NCT ID:
NCT01707368
Status:
COMPLETED
Last Update Posted:
2018-09-24
First Post:
2012-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TANDE@leo-pharma.com', 'phone': '+49 610 220 1258', 'title': 'Tobias Anger, Medical Advisor', 'organization': 'LEO Pharma GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Mean duration of observation per patients: Mean (SD): 40.47 (17.60) weeks.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'All Eligible Patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.', 'otherNumAtRisk': 561, 'deathsNumAtRisk': 561, 'otherNumAffected': 50, 'seriousNumAtRisk': 561, 'deathsNumAffected': 2, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Application site pustules', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sense of oppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Follikulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.'}], 'classes': [{'title': 'No relapse', 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}]}]}, {'title': '1 relapse', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': '2 relapses', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': '3 relapses', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'More than 3 relapses', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of exacerbations and relapses during one year observation time', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least one observation after baseline'}, {'type': 'SECONDARY', 'title': "PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.'}], 'classes': [{'categories': [{'title': 'Free of symptoms', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Almost free of symptoms', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '108', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '350', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}, {'title': 'Very severe', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': '6--point verbal rating scale', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least one severity assessment after baseline'}, {'type': 'SECONDARY', 'title': "PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.'}], 'classes': [{'categories': [{'title': 'Free of symptoms', 'measurements': [{'value': '66', 'groupId': 'OG000'}]}, {'title': 'Almost free of symptoms', 'measurements': [{'value': '177', 'groupId': 'OG000'}]}, {'title': 'Symptoms mild', 'measurements': [{'value': '153', 'groupId': 'OG000'}]}, {'title': 'Symptoms moderate', 'measurements': [{'value': '115', 'groupId': 'OG000'}]}, {'title': 'Symptoms severe', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Symptoms very severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least one observation after baseline (last observation carried forward)'}, {'type': 'SECONDARY', 'title': 'Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.'}], 'classes': [{'title': 'Serious with causal relation probable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious with causal relation possible', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious, not related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Serious, causality not assessible', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious, causal relation probable', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious, causal relation possible', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious, not related', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious, causality not assessible', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of participants with serious and non-serious adverse drug reactions.', 'unitOfMeasure': 'Number of events recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Eligible Patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '561'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}]}]}], 'recruitmentDetails': 'The study was conducted in Germany between 8th September 2011 (retrospective data) and 15th May 2014. The planned observation period for each patient was about 12 months.\n\nThe total planned sample size of this NIS was 1000 (analysable 750) patients.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Eligible Patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51.05', 'spread': '16.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '283', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '278', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '561', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Affected body surface area (BSA) at admission', 'classes': [{'title': '<2%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': '2-4%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}, {'title': '4-6%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}]}]}, {'title': '6-8%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}, {'title': '8-10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': '>10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 561}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2012-10-12', 'resultsFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-24', 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.", 'timeFrame': '1 year', 'description': 'Number of exacerbations and relapses during one year observation time'}], 'secondaryOutcomes': [{'measure': "PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)", 'timeFrame': 'Baseline', 'description': '6--point verbal rating scale'}, {'measure': "PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)", 'timeFrame': '1 year', 'description': 'Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)'}, {'measure': 'Side Effects', 'timeFrame': '1 year', 'description': 'Number of participants with serious and non-serious adverse drug reactions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Psoriasis vulgaris', 'Plaque Psoriasis', 'Daivobet® Gel', 'Germany'], 'conditions': ['Psoriasis Vulgaris', 'Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': "The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway.\n* Minimum of 3 years diagnosed psoriasis vulgaris.\n\nExclusion Criteria:\n\n* Previous therapy with Daivobet® Gel\n* Systemic therapy of psoriasis vulgaris\n* Contraindications of Daivobet® Gel in the German package insert\n* people that are incapable to give free consent'}, 'identificationModule': {'nctId': 'NCT01707368', 'briefTitle': 'Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation', 'orgStudyIdInfo': {'id': 'DE-Daivobet-longterm-NIS-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'all eligible patients', 'description': 'Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.', 'interventionNames': ['Drug: Daivobet® Gel']}], 'interventions': [{'name': 'Daivobet® Gel', 'type': 'DRUG', 'description': 'Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.', 'armGroupLabels': ['all eligible patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49078', 'city': 'Osnabrück', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'PD Dr. med. Rosenbach', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}], 'overallOfficials': [{'name': 'Thomas Rosenberg, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'private practise, D- 49078 Osnabrück, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}