Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02925767
Status:
UNKNOWN
Last Update Posted:
2018-01-19
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The repigmentation rate (change from baseline) of the vitiliginous patch', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The degree of repigmentation will be assessed as % from baseline by using a computer program.'}], 'secondaryOutcomes': [{'measure': 'The adverse effects of both two laser treatments', 'timeFrame': 'At 4 weeks, 8 weeks, and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vitiligo']}, 'referencesModule': {'references': [{'pmid': '30681166', 'type': 'DERIVED', 'citation': 'Bae JM, Eun SH, Lee HN, Kim GM, Grimes PE, Lee JH. Comparison of 311-nm Titanium:Sapphire laser and 308-nm excimer laser treatment for vitiligo: A randomized controlled non-inferiority trial. Lasers Surg Med. 2019 Mar;51(3):239-244. doi: 10.1002/lsm.23048. Epub 2019 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled non-inferiority trial based on split-body was planned to compare the efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.', 'detailedDescription': 'The 308-nm excimer laser (EL) has been widely used for localized vitiligo. Recently, the 311-nm Ti:Sapphire laser (TSL) was developed to treat patients with vitiligo. To compare the efficacy of TSL vs. EL in the treatment of vitiligo.\n\nA randomized controlled non-inferiority trial based on split-body was planned. The paired symmetric vitiliginous lesions will be randomized to either TSL or EL treatment groups. All lesions will be treated twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks, and the non-inferiority margin was set at 10%. Overall 16 patients will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: older than 19\n* A patient with stable non-segmental vitiligo\n* A patient with symmetrical vitiligo lesions\n* A patient with the willingness to comply with the study protocol during the study period and capable of complying with it\n* A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages\n\nExclusion Criteria:\n\n* Age: lower than 20\n* A pregnant or lactating patient\n* A patient with active or spreading vitiligo\n* A patient who cannot understand the study or who does not sign the informed consent'}, 'identificationModule': {'nctId': 'NCT02925767', 'briefTitle': 'Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo', 'orgStudyIdInfo': {'id': 'VC16DISI0088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The 311-nm Ti:Sapphire laser treatment group', 'description': 'All lesions were treated twice weekly for a total of 12-week period.', 'interventionNames': ['Device: 311-nm Ti:Sapphire laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The 308-nm excimer laser treatment group', 'description': 'All lesions were treated twice weekly for a total of 12-week period.', 'interventionNames': ['Device: 308-nm excimer laser']}], 'interventions': [{'name': '311-nm Ti:Sapphire laser', 'type': 'DEVICE', 'description': 'Pallas, LaserOptek, South Korea', 'armGroupLabels': ['The 311-nm Ti:Sapphire laser treatment group']}, {'name': '308-nm excimer laser', 'type': 'DEVICE', 'description': 'XTRAC, PhotoMedex, US', 'armGroupLabels': ['The 308-nm excimer laser treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16247', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung Min Bae, MD', 'role': 'CONTACT', 'email': 'jminbae@gmail.com', 'phone': '82-31-249-8209'}], 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Jung Min Bae, MD, PhD', 'role': 'CONTACT', 'email': 'jminbae@gmail.com', 'phone': '82-31-249-8209', 'phoneExt': '8209'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Jung Min Bae', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}