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
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vitiligo Assessment Scoring Index (VASI)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Depigmented patches of skin
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Carbon Dioxide Laser (Device)
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.
干预措施: MKTP (melanocyte keratinocyte transplant procedure) (Procedure)
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.
干预措施: Collagen Dressing (Device)
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.
干预措施: MKTP (melanocyte keratinocyte transplant procedure) (Procedure)
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.
干预措施: Vaseline Impregnated Gauze (Device)
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.
干预措施: Carbon Dioxide Laser (Device)
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.
干预措施: MKTP (melanocyte keratinocyte transplant procedure) (Procedure)
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.
干预措施: Collagen Dressing (Device)
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.
干预措施: Dermabrasion (Device)
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.
干预措施: MKTP (melanocyte keratinocyte transplant procedure) (Procedure)
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.
干预措施: Vaseline Impregnated Gauze (Device)
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.
干预措施: Dermabrasion (Device)
结局指标
主要结局
Vitiligo Assessment Scoring Index (VASI)
时间窗: 6 months
Assessment of the percentage of repigmentation and color match of the repigmentation.
次要结局
- Time to De-Epithelialization(Assessed at Visit 1 (Day of Procedure))
- Pain Severity Scale(Assessed on Visit 1 (Day of Procedure))
研究者
Iltefat Hamzavi
Principle Investigator
Henry Ford Health System