Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT00678756
Status:
UNKNOWN
Last Update Posted:
2010-06-08
First Post:
2008-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-07', 'studyFirstSubmitDate': '2008-05-14', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PASI, PGA', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'OCT/ultrasound- thickness of epidermis/ dermis', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Psoriasis vulgaris,', 'vitamin D, UVB-phototherapy, ketokonazol,', 'Optical Coherence Tomography,', 'local PASI, Nizoral'], 'conditions': ['Psoriasis Vulgaris']}, 'descriptionModule': {'briefSummary': 'Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18- 80\n* diagnosis of psoriasis vulgaris (mild- middle)\n* no other current antipsoriatic therapy (systemic/topical)\n* at least 5 psoriatic areas of 5x5 cm\n\nExclusion Criteria:\n\n* pregnancy/nursing mothers\n* women in reproductive age without adequate contraception\n* severe and acute forms of psoriasis vulgaris\n* patients receiving systemic or topical antipsoroatic treatment in past 3 month\n* UV-therapy in past 3 month\n* patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma\n* epilepsy'}, 'identificationModule': {'nctId': 'NCT00678756', 'acronym': 'VITAKET', 'briefTitle': 'Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol', 'orgStudyIdInfo': {'id': 'TUD-VITAKET'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ketokonazol 2% cream', 'type': 'DRUG', 'otherNames': ['Nizoral cream'], 'description': 'twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week'}, {'name': 'UVB-radiation 311nm', 'type': 'RADIATION', 'otherNames': ['UVB Radiation, phototherapy, narrow-band ultraviolet B phototherapy'], 'description': '3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Department of Dermatology, Medical Faculty, TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Gottfried Wozel, Prof. Dr.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Medical Faculty, Technical University Dresden, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. med. Gottfried Wozel', 'oldOrganization': 'Technical University Dresden, Department of Dermatology'}}}}