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The purpose of this study is to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MKTP with CO2 Laser/Collagen Dressing | Active Comparator | 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. |
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| MKTP with CO2 laser/vaseline gauze | Active Comparator | 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 with dermabrasion/collagen dressing | Active Comparator | 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. |
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| MKTP with dermabrasion/vaseline gauze | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKTP (melanocyte keratinocyte transplant procedure) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Vitiligo Assessment Scoring Index (VASI) | Assessment of the percentage of repigmentation and color match of the repigmentation. | 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tasneem Mohammad, MD | Contact | 313-916-6964 | ||
| Cynthia Nicholson, MD | Contact | 313-916-6964 |
| Name | Affiliation | Role |
|---|---|---|
| Iltefat H Hamzavi, MD | Henry Ford Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Dermatology | Recruiting | Detroit | Michigan | 48202 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 15, 2022 | |
| Reset | Mar 10, 2022 | |
| Release | Jun 29, 2023 |
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| Collagen Dressing | Device | Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing. |
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| Vaseline Impregnated Gauze | Device | Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze. |
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| Carbon Dioxide Laser | Device | 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. |
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| Dermabrasion | Device | Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion. |
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| Assessed on Visit 1 (Day of Procedure) |
| Reset | Jul 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 15, 2022 | Mar 10, 2022 | |||
| Jun 29, 2023 | Jul 18, 2023 |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| D003869 | Dermabrasion |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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