Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT03047733
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2017-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009824', 'term': 'Ointments'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, controlled, split-body, non-inferiority trial.\n\nPatients with stable symmetric vitiligo were enrolled. The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off excimer laser treatment.\n\nTotal duration of study was 9 months.\n\nIn cyclic on-off excimer laser treatment, the cycle was arbitrarily determined that one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2017-02-05', 'studyFirstSubmitQcDate': '2017-02-07', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment.', 'timeFrame': 'Through study completion, an average of 9 months', 'description': 'The degree of repigmentation was assessed with a repigmentation rate (%) with clinical photographs by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vitiligo', '308 nm excimer laser'], 'conditions': ['Dermatologic Disease', 'Vitiligo']}, 'referencesModule': {'references': [{'pmid': '20584252', 'type': 'BACKGROUND', 'citation': 'Zhang XY, He YL, Dong J, Xu JZ, Wang J. Clinical efficacy of a 308 nm excimer laser in the treatment of vitiligo. Photodermatol Photoimmunol Photomed. 2010 Jun;26(3):138-42. doi: 10.1111/j.1600-0781.2010.00509.x.'}, {'pmid': '15888156', 'type': 'BACKGROUND', 'citation': 'Hofer A, Hassan AS, Legat FJ, Kerl H, Wolf P. Optimal weekly frequency of 308-nm excimer laser treatment in vitiligo patients. Br J Dermatol. 2005 May;152(5):981-5. doi: 10.1111/j.1365-2133.2004.06321.x.'}, {'pmid': '22524428', 'type': 'BACKGROUND', 'citation': 'Park KK, Liao W, Murase JE. A review of monochromatic excimer light in vitiligo. Br J Dermatol. 2012 Sep;167(3):468-78. doi: 10.1111/j.1365-2133.2012.11008.x. Epub 2012 Aug 8.'}, {'pmid': '7907336', 'type': 'RESULT', 'citation': 'Aberdam E, Romero C, Ortonne JP. Repeated UVB irradiations do not have the same potential to promote stimulation of melanogenesis in cultured normal human melanocytes. J Cell Sci. 1993 Dec;106 ( Pt 4):1015-22. doi: 10.1242/jcs.106.4.1015.'}]}, 'descriptionModule': {'briefSummary': "OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the conventional continuous excimer laser treatment.\n\nDESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was performed in two tertiary health care centers in Korea.\n\nPARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5 years' disease duration were enrolled.\n\nINTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles). Topical tacrolimus was applied throughout the trial.\n\nOUTCOME MEASURES: The repigmentation was assessed using an image analysis program with clinical photographs. The primary outcome was mean difference of repigmentation rates and the non-inferiority margin was set at 10%. During intermission period, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.", 'detailedDescription': "\\[Study design and population\\] A randomized, controlled, split-body, non-inferiority trial was designed.\n\nAfter obtaining informed consent, 12 patients with stable symmetric vitiligo less than 5 years' disease duration were enrolled.\n\nThe patients taking systemic steroids or having enlarging lesions were excluded. The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic excimer laser treatment.\n\nTotal duration of study was 9 months.\n\nIn cyclic excimer laser treatment, the cycle was arbitrarily determined that one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off) (total 3 cycles during the trial).\n\n\\[Treatment protocol\\]\n\nThe lesions were treated twice a week. Initial irradiation dose was 50 mJ/cm2 on face and 100 mJ/cm2 on trunk and extremities. If there had not been minimal asymptomatic erythema, energy level was escalated by 50 mJ/cm2. In cyclic treatment, the treatment resumed after intermission with the previously used irradiation dose.\n\nTopical tacrolimus 0.1% ointment was applied in both twice daily throughout whole length of the trial.\n\n\\[Assessment and primary outcome\\] Photographic documentation of lesions was conducted every month and the degree of repigmentation was assessed with a repigmentation rate (%) from the baseline by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea).\n\nAn intention-to-treat analysis was planned, and last observation carried forward method was applied to impute the missing value in the presence of dropouts.\n\nThe primary outcome was mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment. The non-inferiority margin was set at 10%. During intermission period in the cyclic treatment, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.\n\n\\[Statistical analysis\\] All statistical analyses were conducted using R 3.2.4 (R Foundation for Statistical Computing, Austria) and a P value \\<0.05 was considered statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with symmetric vitiligo\n* Patients with less than 5 years' disease duration\n\nExclusion Criteria:\n\n* The patients taking systemic steroids\n* The patients with currently enlarging lesions\n* The patients who cannot follow the treatment schedule"}, 'identificationModule': {'nctId': 'NCT03047733', 'briefTitle': 'Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'AJIRB-MED-DE3-15-151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'continuously excimer laser treatment', 'description': 'In this group, lesions treated twice weekly through out the whole trial length (9 months).\n\nApplication of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).', 'interventionNames': ['Device: The XTRAC Excimer Laser System', 'Drug: Topical tacrolimus 0.1% ointment']}, {'type': 'EXPERIMENTAL', 'label': 'cyclic excimer laser treatment', 'description': 'In this group, one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off).\n\nTotal 3 cycles of cyclic treatment through out the whole trial length (9 months). During the treatment period, lesions treated twice weekly.\n\nApplication of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).', 'interventionNames': ['Device: The XTRAC Excimer Laser System', 'Drug: Topical tacrolimus 0.1% ointment']}], 'interventions': [{'name': 'The XTRAC Excimer Laser System', 'type': 'DEVICE', 'otherNames': ['XTRAC Velocity 400'], 'description': 'Initial irradiation dose was 50 mJ/cm2 on face and 100 mJ/cm2 on trunk and extremities. If there had not been minimal asymptomatic erythema, energy level was escalated by 50 mJ/cm2.', 'armGroupLabels': ['continuously excimer laser treatment', 'cyclic excimer laser treatment']}, {'name': 'Topical tacrolimus 0.1% ointment', 'type': 'DRUG', 'description': 'Application of topical tacrolimus 0.1% ointment on the both lesions once daily.', 'armGroupLabels': ['continuously excimer laser treatment', 'cyclic excimer laser treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou university hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'HEE YOUNG KANG, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of the department of dermatology', 'investigatorFullName': 'Jae Min Sung', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}