Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-29 @ 7:41 AM
Study NCT ID:
NCT00696358
Status:
COMPLETED
Last Update Posted:
2008-10-31
First Post:
2008-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Excimer Lamp Versus Excimer Laser in Vitiligo Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054018', 'term': 'Lasers, Excimer'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2008-10-30', 'studyFirstSubmitDate': '2008-06-10', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repigmentation rate in the treated areas', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Tolerance and safety of the treatments', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Vitiligo'], 'conditions': ['Vitiligo']}, 'descriptionModule': {'briefSummary': '308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication.\n\nThe aim of the study is to make an intra-individual prospective comparison between these two phototherapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient above 18\n* vitiligo for more than 3 months\n* at least 2 vitiligo symmetric patches more than 10cm²\n* to read and understand the inform consent\n* to have a social security number\n* non pregnant for women\n\nExclusion Criteria:\n\n* pregnant women\n* keloids\n* history of radiotherapy or skin cancer in the treated areas\n* treatment for vitiligo in the past 4 weeks\n* phototherapy in the past 12 weeks; history of photodermatosis\n* treatment inducing photosensibilization\n* immunosuppression\n* patient who participated in a study in the past 3 months'}, 'identificationModule': {'nctId': 'NCT00696358', 'briefTitle': 'Excimer Lamp Versus Excimer Laser in Vitiligo Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo', 'orgStudyIdInfo': {'id': 'NICE-VIT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': '308 nm excimer lamp', 'interventionNames': ['Radiation: 308nm excimer lamp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': '308 nm excimer laser', 'interventionNames': ['Radiation: 308nm excimer laser']}], 'interventions': [{'name': '308nm excimer lamp', 'type': 'RADIATION', 'description': '50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks', 'armGroupLabels': ['A']}, {'name': '308nm excimer laser', 'type': 'RADIATION', 'description': '50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks (same doses will be used between the 2 arms)', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'Department of Dermatology, University Hospital of Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}}}}