Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP

Study Overview
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Brief Summary
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The purpose of this study is to: Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing

Detailed Description
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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. 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.

Official Title
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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

Conditions
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Vitiligo, Depigmented Scars, Depigmentation

Intervention / Treatment
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* Procedure: MKTP (melanocyte keratinocyte transplant procedure)
* Device: Collagen Dressing
* Device: Vaseline Impregnated Gauze
* Device: Carbon Dioxide Laser
* Device: Dermabrasion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Depigmented patches of skin Exclusion Criteria: History of Acral Vitiligo 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MKTP with CO2 Laser/Collagen Dressing<br>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. | Procedure: MKTP (melanocyte keratinocyte transplant procedure)<br>* 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).<br>* Other names: MKTP;Device: Collagen Dressing<br>* Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.<br>Device: Carbon Dioxide Laser<br>* 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.<br>* Other names: CO2 laser;|
| Active Comparator: MKTP with CO2 laser/vaseline gauze<br>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. | Procedure: MKTP (melanocyte keratinocyte transplant procedure)<br>* 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).<br>* Other names: MKTP;Device: Vaseline Impregnated Gauze<br>* Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.<br>Device: Carbon Dioxide Laser<br>* 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.<br>* Other names: CO2 laser;|
| Active Comparator: MKTP with dermabrasion/collagen dressing<br>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. | Procedure: MKTP (melanocyte keratinocyte transplant procedure)<br>* 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).<br>* Other names: MKTP;Device: Collagen Dressing<br>* Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.<br>Device: Dermabrasion<br>* Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.<br>|
| Active Comparator: MKTP with dermabrasion/vaseline gauze<br>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. | Procedure: MKTP (melanocyte keratinocyte transplant procedure)<br>* 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).<br>* Other names: MKTP;Device: Vaseline Impregnated Gauze<br>* Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.<br>Device: Dermabrasion<br>* Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitiligo Assessment Scoring Index (VASI) | Assessment of the percentage of repigmentation and color match of the repigmentation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to De-Epithelialization | Amount of time needed to de-epithelialize the skin using carbon dioxide laser versus dermabrasion | Assessed at Visit 1 (Day of Procedure) | 
| Pain Severity Scale | 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. | Assessed on Visit 1 (Day of Procedure) |