Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT01052467
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2010-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 724}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2010-01-19', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physician's Global Assessment of scalp psoriasis", 'timeFrame': 'After approximately 4 weeks'}], 'secondaryOutcomes': [{'measure': "Patient's Quality of Life", 'timeFrame': 'After approximately 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Scalp Psoriasis']}, 'descriptionModule': {'briefSummary': 'This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting their attending dermatologist in the primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway\n\nExclusion Criteria:\n\n* Contraindications of Xamiol® Gel listed in the German package insert\n* Pretreatment with Xamiol® within the last 4 weeks\n* Systemic treatment of psoriasis\n* UV light therapy'}, 'identificationModule': {'nctId': 'NCT01052467', 'briefTitle': 'Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)', 'orgStudyIdInfo': {'id': 'Treatment with Xamiol® Gel'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Xamiol® Gel', 'type': 'DRUG', 'description': 'Once daily application for about 4 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Clinical Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Ulrich Mrowietz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic Schleswig-Holstein'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}