Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 3:29 PM
Study NCT ID:
NCT00216892
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2005-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C055085', 'term': 'calcipotriene'}, {'id': 'D001623', 'term': 'Betamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1032}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2005-12'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2005-09-15', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12'}], 'secondaryOutcomes': [{'measure': 'Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)'}]}, 'conditionsModule': {'conditions': ['Psoriasis Vulgaris']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:\n\n1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream\n2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends\n3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream\n\nThe objective is to compare the efficacy and safety of the different treatment regimens', 'detailedDescription': 'A phase IV study of different treatment regimens of calcipotriol 50 mcg/g cream and combination (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) ointment following treatment with combination ointment in psoriasis vulgaris'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with psoriasis vulgaris of trunk and/or limbs\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00216892', 'briefTitle': 'Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris', 'orgStudyIdInfo': {'id': 'MCB 0402 INT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calcipotriol, (calcipotriol + betamethasone)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'L8N 1V6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dermatrials Research Dermatology Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Hôpital Nord, Service de Dermatologie', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '6532', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius-Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '08221', 'city': 'Terrassa', 'country': 'Spain', 'facility': 'Hospital Mutua de Terrassa Dermatology Service', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': 'L63 4JY', 'city': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Clatterbridge Hospital, Department of Dermatology'}], 'overallOfficials': [{'name': 'S White, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clatterbridge Hospital, Department of Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}}}}