Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00263718
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2005-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C055085', 'term': 'calcipotriene'}, {'id': 'C011175', 'term': 'betamethasone-17,21-dipropionate'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2006-05'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2005-12-08', 'studyFirstSubmitQcDate': '2005-12-08', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients with "controlled disease" (minimal or clear and at least two steps change from baseline) according to the investigators\' global assessment of disease severity at week 4 and week 8.'}], 'secondaryOutcomes': [{'measure': 'The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.'}, {'measure': 'Patients with "controlled disease" according to the investigators\' global assessment of disease severity at week 1, 2, and 6.'}, {'measure': 'Patients with "clear" or "very mild" disease by the patient\'s global assessment of disease severity at week 1, 2, 4, 6, and 8.'}]}, 'conditionsModule': {'conditions': ['Psoriasis Vulgaris']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.\n\nThe primary response criterion is the number of patients with controlled disease at week 8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week\n* An investigators' global assessment of disease severity of at least mild\n\nExclusion Criteria:\n\n* PUVA or Grenz ray therapy within 4 weeks prior to randomisation\n* UVB therapy within 2 weeks prior to randomisation\n* Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within 6 months prior to randomisation\n* Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation\n* Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation\n* Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation\n* Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study\n* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis"}, 'identificationModule': {'nctId': 'NCT00263718', 'briefTitle': 'Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle Alone in Psoriasis Vulgaris', 'orgStudyIdInfo': {'id': 'MBL 0202 INT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calcipotriol plus betamethasone dipropionate (LEO 80185) gel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A3H7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Guenther Dermatology Research Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Waterford', 'country': 'Ireland', 'facility': 'Waterford Regional Hospital', 'geoPoint': {'lat': 52.25833, 'lon': -7.11194}}, {'zip': '16268', 'city': 'Vällingby', 'country': 'Sweden', 'facility': 'Läkarhuset Vällingby', 'geoPoint': {'lat': 59.36441, 'lon': 17.87407}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital and Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Colin Fleming, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ninewells Hospital and Medical School, Ninewells, Dundee, UK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}}}}