Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-10 @ 3:04 PM
Study NCT ID:
NCT02510651
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2015-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Procedural Variables on Outcome of Surgical Treatment of 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': 'D054020', 'term': 'Lasers, Gas'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients with satisfactory response after the surgical procedure for vitiligo.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': [': non-segmental vitiligo', 'melanocyte-keratinocyte suspension', 'cryoblebbing', 'CO2 laser'], 'conditions': ['Vitiligo']}, 'descriptionModule': {'briefSummary': 'ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.', 'detailedDescription': 'Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.\n\nObjective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.\n\nMethods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable non-segmental vitiligo\n\nExclusion Criteria:\n\n* Active vitiligo'}, 'identificationModule': {'nctId': 'NCT02510651', 'briefTitle': 'Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study', 'orgStudyIdInfo': {'id': 'DAH555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ORSHFS', 'description': 'Melanocyte-keratinocyte suspension.', 'interventionNames': ['Procedure: Melanocyte-keratinocyte suspension']}], 'interventions': [{'name': 'Melanocyte-keratinocyte suspension', 'type': 'PROCEDURE', 'otherNames': ['CO2 laser'], 'description': 'Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.', 'armGroupLabels': ['ORSHFS']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professorof dermatology', 'investigatorFullName': 'Dalia Abdel Halim', 'investigatorAffiliation': 'Cairo University'}}}}