Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT00248456
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2005-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C055085', 'term': 'calcipotriene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2005-11-03', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage change of PASI at the end of week 4 compared with baseline'}], 'secondaryOutcomes': [{'measure': 'The change of PASI at the end of week 4 compared with baseline'}, {'measure': 'The change of Dermatology Life Quality Index at the end of week 4 compared with baseline'}, {'measure': "Physician's Global Assessment at the end of week 4"}, {'measure': "Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4"}, {'measure': 'The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline'}, {'measure': 'The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline'}]}, 'conditionsModule': {'conditions': ['Psoriasis Vulgaris']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change of the psoriasis area and severity index (PASI) from baseline to the end of week 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of psoriasis vulgaris in a stable condition\n* Extent of at least 10% of one or more body regions\n* Amenable to topical therapy with maximum of 100 g/week of investigational product\n\nExclusion Criteria:\n\n* Patients with more than 30% of body surface area involved\n* Patients with facial psoriasis who need treatment\n* Patients who need treatment of scalp psoriasis with WHO group IV topical corticosteroids, tretinoin or topical vitamin D derivatives\n* Patients with unstable forms of psoriasis including guttate, erythrodermic, pustular, or arthritis psoriasis\n* Systemic treatment of psoriasis with corticosteroids or other therapy\n* Systemic antipsoriatic treatment (e.g. corticosteroids, immunosuppressive drugs, tretinoin, antibiotics, phototherapy or calcium agents) within 4 weeks prior to visit 1; or topical antipsoriatic treatment (e.g. keratolytics, topical corticosteroids, topical vitamin D derivatives, anthralin, crude coal tar, etc) within the previous 2 week period\n* Patients with planned exposure to phototherapy that may affect the psoriasis during the study period'}, 'identificationModule': {'nctId': 'NCT00248456', 'briefTitle': 'Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A Randomised, Double-blind, Active-controlled, Parallel, Multi-center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris', 'orgStudyIdInfo': {'id': 'EX 0501 CN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calcipotriol plus betamethasone dipropionate ointment', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University First Hospital, Dermatology Department', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zheng Zhi Zhong, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University First Hospital, Dermatology Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}}}}