Efficacy of Narrow-band UVB Treatment After Transplantation of Harvested Epidermal Cells in Vitiligo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- percentage of repigmentation
研究概览
简要总结
The effect of treatment with narrow-band UVB 311 nm after transplantation of harvested autologous epidermal cells on vitiligo lesions will be investigated.
详细描述
Introduction: Surgical interventions in vitiligo are widely used and additional UV exposure is often recommended after successful transplantation. However, little is known about the additional efficacy of (narrow-band) UVB due to missing comparative studies.
Aim of the study: To perform a prospective, controlled, randomized, intra-individual comparative study in vitiligo lesions treated with epidermal cell transplantation using the ReCell method with and without additional narrow-band UVB treatment.
Study design: Two weeks after transplantation of epidermal cells, one randomly chosen half of the transplanted patch will be additionally treated with narrow-band UVB therapy whereas the other half will be left untreated. For control purpose, 2 additional patches (or the two halfs of one patch) will be selected to be treated with either laser dermabrasion and narrow-band UVB or narrow-band UVB treatment alone.
Grafting with the ReCell method: A superficial skin shaving excision of 2 x 2 cm will be obtained from pigmented skin (UVA irradiation 4 weeks before the excision) using a Silver knife. A cell suspension will be obtained using the ReCell transplantation kit, according to the instructions of the manufactures. The vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. Thereafter the cell suspension will be sprayed on the dermabraded skin area and fixed with special wound dressings.
Narrow-band UVB treatment: The initial UVB dose will be 50% of the minimal erythema dose, tested next to the vitiligo lesions to be treated. Treatment will be performed 2 times a week with a targeted UVB device (Dualight, TheraLight). Dose increments will be 30 mJ/cm2 at each treatment up to a dose that induces slight erythema longer than 24 hours. If this dose is reached, the dose will be reduced to the last well tolerated dose and no further increments will follow. 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
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11 female or male vitiligo patients between the age of 18 and 70
- •Stable vitiligo for at least 1 year
排除标准
- •Progressive disease within the last 12 months
- •Sporadic repigmentation of single patches within the last 12 months
- •Patients with contraindications for UV-treatment
- •Patients with anticoagulant treatment, bleeding disorders
- •Patients with prolonged wound healing in the history
- •History of hypertrophic scarring or keloids or Köbner phenomenon
- •Reduced general health status
- •Patients with allergic reactions to local anaesthesia
- •Topical steroids or calcineurin inhibitors in the last 4 weeks before study entry
- •UV exposure in the last 4 weeks before study entry
- •Pregnancy or lactation
研究组 & 干预措施
Body location
Different body locations receive specific treatments
干预措施: UVB 311 nm radiation (Radiation)
Control
Treatment with narrow-band UVB
干预措施: UVB 311 nm radiation (Radiation)
Control
Treatment with narrow-band UVB
干预措施: UVB 311nm (Device)
结局指标
主要结局
percentage of repigmentation
时间窗: 3 and 6 months after transplantation
次要结局
- stability of the achieved repigmentation(one year after transplantation)