Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 5:19 AM
Study NCT ID:
NCT03384459
Status:
UNKNOWN
Last Update Posted:
2017-12-27
First Post:
2017-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-05-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-25', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-25', 'lastUpdatePostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of vitiligo', 'timeFrame': 'Change from Baseline area score at 12 months', 'description': 'Clinical photographs taken before and 12 months after the completion of the study. The photographs will be used to measure the area of vitiligo lesion, and the investigators will compare the area score and judge whether or not there is a recurrence.'}], 'secondaryOutcomes': [{'measure': 'The assessment of patient satisfaction', 'timeFrame': 'at Baseline and at 12 months', 'description': 'The assessment of patient satisfaction using five-point Likert scale (Scale 1: strongly not-satisfied, Scale 2: Not-satisfied, Scale 3: Neither satisfied nor not-satisfied, Scale 4: Satisfied, Scale 5: Strongly satisfied)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitiligo', '308-nm excimer laser', 'maintenance therapy', 'recurrence'], 'conditions': ['Vitiligo', 'Maintenance Therapy', 'the 308-nm Excimer Laser', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy. The aim of this study was to evaluate the efficacy of 308-nm excimer laser therapy for the prevention of relapse in vitiligo.', 'detailedDescription': 'For a total period of 12 months, perform the 308-nm excimer laser treatment once a month. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.\n\nAn independent evaluator will obtain the score of vitiligo area (Vitiligo Extent Score) from comparing clinical photographs of before registration and after the clinical trial, and judge whether vitiligo is recurred. This study is a randomized controlled trial, and the investigators plan to compare the recurrence rates of the experimental and control groups using the Chi-squared test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with age of 19 years or older\n2. Patients of generalized vitiligo with lesions on the trunk\n3. Patients who had treated with the 308-nm excimer laser previously and achieved more than 75% lesion improvement\n4. Patients who voluntarily agreed to participate in the study\n\nExclusion Criteria:\n\n1. Patients under the age of 19\n2. Patients with localized vitiligo and segmental vitiligo\n3. Patients who are in a state of physical or mental impairment to perform treatment or pregnant\n4. Patients with spreading of vitiligo lesions\n5. Patients who do not want to do thie study or who refuse to write a consent form\n6. Any other person deemed unsuitable for the examination at the discretion of the examiner'}, 'identificationModule': {'nctId': 'NCT03384459', 'briefTitle': 'Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo', 'orgStudyIdInfo': {'id': 'VC17DEDI0186'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'For a total period of 12 months, perform the 308-nm excimer laser treatment once a month.\n\nAt this time, the dose of the 308-nm excimer laser is based on the 50% of the maximum dose that the patient received for the treatment.\n\nCheck for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.\n\nIf recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence.', 'interventionNames': ['Device: the 308-nm excimer laser']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.\n\nIf recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence.'}], 'interventions': [{'name': 'the 308-nm excimer laser', 'type': 'DEVICE', 'description': 'For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16247', 'city': 'Suwon', 'state': 'Gyonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung Min Bae, MD, PhD', 'role': 'CONTACT', 'email': 'jminbae@gmail.com', 'phone': '+82.31-249-7461'}], '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': '82-31-249-7460'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jung Min Bae', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}