Efficacy and Tolerance of Transplantation of Harvested Epidermal Cells and Narrow-Band UVB in Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Repigmentation rate at 12 months
研究概览
简要总结
The effects of treatment of transplantation of harvested autologous epidermal cells on vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled study.
详细描述
Introduction: Transplantation of harvested autologous epidermal cells in vitiligo is widely used in vitiligo but randomized controlled trials in the literature investigating the efficacy of these noncultured keratinocyte/melanocyte suspensions are scarce. In addition there are few data regarding the relationship between the cellular contents of epidermal suspensions and the clinical outcome.
Aim of the study: To perform a prospective, controlled, randomized, intra-individual comparative study in vitiligo lesions treated with epidermal cell transplantation with additional narrow-band UVB treatment using epidermal cell suspensions that have been characterized at the cellular level.
Study design:
Grafting with epidermal cells: A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated.
Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18yr
- •Stable vitiligo (no lesion since 12 mo)
- •2 symmetrical vitiligo patches of at least 10 cm2
- •Vitiligo requiring UVB treatment
- •Women using a contraceptive
排除标准
- •History of keloids
- •History of skin cancer
- •Photosensitivity
- •Positive blood test for HIV, HBV, HVC, or HTLV1
- •Pregnant or breastfeeding women
结局指标
主要结局
Repigmentation rate at 12 months
时间窗: 12months
Repigmentation rate at 12 months
次要结局
- Repigmentation > 70% at 12 months(12 months)