Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT00216827
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2005-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2005-09'}, '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': "Overall disease severity according to investigator's assessment at week 8"}], 'secondaryOutcomes': [{'measure': 'Total sign score at week 8'}, {'measure': 'Score for scaliness, redness and thickness at week 8'}, {'measure': 'Extent of scalp psoriasis at week 8'}, {'measure': "Overall disease severity according to investigator's assessment at week 2 and 4"}, {'measure': 'Overall disease severity according to patients at week 8'}, {'measure': 'Adverse events'}, {'measure': 'Laboratory data'}]}, 'conditionsModule': {'conditions': ['Psoriasis of Scalp']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.\n\nThe primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Scalp psoriasis amenable to topical treatment\n* Psoriasis vulgaris on trunk and/or limbs\n* Extent of scalp psoriasis involving more than 10% of the total scalp area\n* Disease severity on the scalp graded as mild or worse by the investigator\n* Consenting out-patients of 18 years or above\n\nMain Exclusion Criteria:\n\n* PUVA or Grenz ray therapy within 4 weeks prior to randomisation\n* UVB therapy within 2 weeks prior to randomisation\n* Systematic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation\n* Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation\n* Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation\n* Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation\n* Current diagnosis of erythrodermic, exfoliative or pustular psoriasis'}, 'identificationModule': {'nctId': 'NCT00216827', 'briefTitle': 'Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis', '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 Scalp Psoriasis', 'orgStudyIdInfo': {'id': 'MBL 0405 INT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calcipotriol plus betamethasone dipropionate (LEO80185 gel)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4X7', 'city': 'Québec', 'country': 'Canada', 'facility': 'FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Roskilde Hospital, Division of Dermatology', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "Hôpital de l'Archet, Service de Dermatologie", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '1338', 'city': 'Sandvika', 'country': 'Norway', 'facility': 'Hudlegekontoret', 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra, Servico de dermatologia', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen de la Macarena, Servicio de Dermatología', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Akademiska Sjukhuset, Hudkliniken', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Western Infirmary, Dermatology Department', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Gregor Jemec, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roskilde Hospital, Division of Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}}}}