Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-11 @ 2:41 PM
Study NCT ID:
NCT02038257
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-10', 'releaseDate': '2022-02-15'}, {'resetDate': '2023-07-18', 'releaseDate': '2023-06-29'}], 'estimatedResultsFirstSubmitDate': '2022-02-15'}}, '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'}, {'id': 'D003869', 'term': 'Dermabrasion'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D062109', 'term': 'Dermatologic Surgical Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitiligo Assessment Scoring Index (VASI)', 'timeFrame': '6 months', 'description': 'Assessment of the percentage of repigmentation and color match of the repigmentation.'}], 'secondaryOutcomes': [{'measure': 'Time to De-Epithelialization', 'timeFrame': 'Assessed at Visit 1 (Day of Procedure)', 'description': 'Amount of time needed to de-epithelialize the skin using carbon dioxide laser versus dermabrasion'}, {'measure': 'Pain Severity Scale', 'timeFrame': 'Assessed on Visit 1 (Day of Procedure)', 'description': 'Assess pain experienced on a severity scale from 0-10 during de-epithelialization with carbon dioxide laser versus dermabrasion, and during dressing application with vaseline impregnated gauze versus collagen dressing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vitiligo', 'Depigmented Scars', 'Depigmentation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n1. Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion\n2. Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing', 'detailedDescription': 'The melanocyte keratinocyte transplant procedure (MKTP) has been shown to be effective in treating vitiligo and other conditions with depigmented skin. MKTP involves the transplantation of melanocytes and keratinocytes from normal skin onto the depigmented skin in order to repigment the skin.\n\nBoth dermabrasion and carbon dioxide lasers have been used effectively in MKTP to denude the epithelium. This study will compare the efficacy of these two techniques.\n\nThe study will also compare the efficacy of two different dressings used in MKTP, vaseline impregnated gauze and collagen dressings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Depigmented patches of skin\n\nExclusion Criteria:\n\n* History of Acral Vitiligo\n* Unstable Vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months\n* History of hypertrophic scarring or keloids\n* History of koebnerization (new patches of vitiligo at sites of injury or trauma)'}, 'identificationModule': {'nctId': 'NCT02038257', 'acronym': 'MKTP', 'briefTitle': 'Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Prospective Open Label Parallel Study Comparing Use of Carbon Dioxide Laser Versus Dermabrasion for Denuding Epithelium and Collagen Dressing Versus Vaseline Impregnated Gauze for the Melanocyte Keratinocyte Transplant Procedure', 'orgStudyIdInfo': {'id': '8082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MKTP with CO2 Laser/Collagen Dressing', 'description': 'Each Subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and a collagen dressing for the wound dressing.', 'interventionNames': ['Procedure: MKTP (melanocyte keratinocyte transplant procedure)', 'Device: Collagen Dressing', 'Device: Carbon Dioxide Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MKTP with CO2 laser/vaseline gauze', 'description': 'Each subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and vaseline impregnated gauze as the wound dressing.', 'interventionNames': ['Procedure: MKTP (melanocyte keratinocyte transplant procedure)', 'Device: Vaseline Impregnated Gauze', 'Device: Carbon Dioxide Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MKTP with dermabrasion/collagen dressing', 'description': 'Each subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and a collagen dressing for the wound dressing.', 'interventionNames': ['Procedure: MKTP (melanocyte keratinocyte transplant procedure)', 'Device: Collagen Dressing', 'Device: Dermabrasion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MKTP with dermabrasion/vaseline gauze', 'description': 'Each subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and vaseline impregnated gauze as a wound dressing.', 'interventionNames': ['Procedure: MKTP (melanocyte keratinocyte transplant procedure)', 'Device: Vaseline Impregnated Gauze', 'Device: Dermabrasion']}], 'interventions': [{'name': 'MKTP (melanocyte keratinocyte transplant procedure)', 'type': 'PROCEDURE', 'otherNames': ['MKTP'], 'description': 'Each subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing).', 'armGroupLabels': ['MKTP with CO2 Laser/Collagen Dressing', 'MKTP with CO2 laser/vaseline gauze', 'MKTP with dermabrasion/collagen dressing', 'MKTP with dermabrasion/vaseline gauze']}, {'name': 'Collagen Dressing', 'type': 'DEVICE', 'description': 'Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.', 'armGroupLabels': ['MKTP with CO2 Laser/Collagen Dressing', 'MKTP with dermabrasion/collagen dressing']}, {'name': 'Vaseline Impregnated Gauze', 'type': 'DEVICE', 'description': 'Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.', 'armGroupLabels': ['MKTP with CO2 laser/vaseline gauze', 'MKTP with dermabrasion/vaseline gauze']}, {'name': 'Carbon Dioxide Laser', 'type': 'DEVICE', 'otherNames': ['CO2 laser'], 'description': 'Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using a carbon dioxide laser.', 'armGroupLabels': ['MKTP with CO2 Laser/Collagen Dressing', 'MKTP with CO2 laser/vaseline gauze']}, {'name': 'Dermabrasion', 'type': 'DEVICE', 'description': 'Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.', 'armGroupLabels': ['MKTP with dermabrasion/collagen dressing', 'MKTP with dermabrasion/vaseline gauze']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tasneem Mohammad, MD', 'role': 'CONTACT', 'phone': '313-916-6964'}, {'name': 'Cynthia Nicholson, MD', 'role': 'CONTACT', 'phone': '313-916-6964'}], 'facility': 'Henry Ford Dermatology', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'centralContacts': [{'name': 'Tasneem Mohammad, MD', 'role': 'CONTACT', 'phone': '313-916-6964'}, {'name': 'Cynthia Nicholson, MD', 'role': 'CONTACT', 'phone': '313-916-6964'}], 'overallOfficials': [{'name': 'Iltefat H Hamzavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Iltefat Hamzavi', 'investigatorAffiliation': 'Henry Ford Health System'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-02-15', 'type': 'RELEASE'}, {'date': '2022-03-10', 'type': 'RESET'}, {'date': '2023-06-29', 'type': 'RELEASE'}, {'date': '2023-07-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Iltefat Hamzavi, Principle Investigator, Henry Ford Health System'}}}}