Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT00748020
Status:
COMPLETED
Last Update Posted:
2008-09-08
First Post:
2008-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Narrow-Band UVB-Therapy in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-05', 'studyFirstSubmitDate': '2008-09-05', 'studyFirstSubmitQcDate': '2008-09-05', 'lastUpdatePostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clearance is defined as less than 10% affected body area with psoriasis compared with baseline', 'timeFrame': 'every 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Study on two different irradiation schemes in UVB phototherapy for psoriasis. Previous studies demonstrated a similar clinical effect in erythematogenic and suberythematogenic irradiation, with less complications in suberythematogenic irradiation. Most of these studies used both irradiation schemes within the same patient. UVB has a systemic effect on the body. Our hypothesis is that previous conclusions are incorrect and that the erythematogenic scheme will result in earlier clearance of the psoriasis.', 'detailedDescription': '109 psoriasis patients, referred for UVB phototherapy, participated in our study after given their written informed consent. After determining the minimal erythema dose (MED) patients were randomised in either group 1, erythematogenic scheme, or group 2, suberythematogenic scheme. Group 1 started with 70% of MED and every following irradiation with an increase of 40%. Group 2 started with 30% of MED and every next visit an increase of 20%. The study protocol was adjusted in case of erythema (sunburn) according to a standard erythema-phototherapy protocol, varying from skip one irradiation to lowering the percentage of increase. In case of clearance the study stopped. Clearance was defined as less than 10% of baseline body area of psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for UVB phototherapy\n* Older than 18 years\n\nExclusion Criteria:\n\n* No topical medication for 2 weeks\n* No systemic medication for 4 weeks\n* No medication (betablocker, lithium) interfering with psoriasis'}, 'identificationModule': {'nctId': 'NCT00748020', 'briefTitle': 'Narrow-Band UVB-Therapy in Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Narrow-Band UVB-Therapy in Psoriasis: Randomised Double-Blind Comparison of Erythematogenic and Suberythematogenic Irradiation Regimens', 'orgStudyIdInfo': {'id': 'UVB-MKL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1', 'description': 'Erythematogenic irradiation scheme', 'interventionNames': ['Procedure: UVB phototherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'description': 'Suberythematogenic irradiation scheme', 'interventionNames': ['Procedure: UVB phototherapy']}], 'interventions': [{'name': 'UVB phototherapy', 'type': 'PROCEDURE', 'description': 'Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose', 'armGroupLabels': ['group 1']}, {'name': 'UVB phototherapy', 'type': 'PROCEDURE', 'description': 'Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GL', 'city': 'Nijmegen', 'state': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre, Department of Dermatology', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Rianne Gerritsen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'M.J.P. Gerritsen, MD, PhD', 'oldOrganization': 'Radboud University Nijmegen Medical Centre'}}}}