Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP
NCT ID: NCT02038257
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-01-31
2019-07-31
Brief Summary
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1. Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion
2. Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing
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Detailed Description
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Both 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.
The study will also compare the efficacy of two different dressings used in MKTP, vaseline impregnated gauze and collagen dressings.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MKTP with CO2 Laser/Collagen Dressing
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.
MKTP (melanocyte keratinocyte transplant procedure)
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).
Collagen Dressing
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Carbon Dioxide Laser
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.
MKTP with CO2 laser/vaseline gauze
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.
MKTP (melanocyte keratinocyte transplant procedure)
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).
Vaseline Impregnated Gauze
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
Carbon Dioxide Laser
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.
MKTP with dermabrasion/collagen dressing
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.
MKTP (melanocyte keratinocyte transplant procedure)
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).
Collagen Dressing
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Dermabrasion
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
MKTP with dermabrasion/vaseline gauze
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.
MKTP (melanocyte keratinocyte transplant procedure)
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).
Vaseline Impregnated Gauze
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
Dermabrasion
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
Interventions
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MKTP (melanocyte keratinocyte transplant procedure)
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).
Collagen Dressing
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Vaseline Impregnated Gauze
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
Carbon Dioxide Laser
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.
Dermabrasion
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unstable Vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months
* History of hypertrophic scarring or keloids
* History of koebnerization (new patches of vitiligo at sites of injury or trauma)
18 Years
ALL
Yes
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Iltefat Hamzavi
Principle Investigator
Principal Investigators
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Iltefat H Hamzavi, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Dermatology
Locations
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Henry Ford Dermatology
Detroit, Michigan, United States
Countries
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Central Contacts
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Tasneem Mohammad, MD
Role: CONTACT
Cynthia Nicholson, MD
Role: CONTACT
Facility Contacts
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Tasneem Mohammad, MD
Role: primary
Cynthia Nicholson, MD
Role: backup
Other Identifiers
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8082
Identifier Type: -
Identifier Source: org_study_id
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