Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Study on the Recipient Site Preparation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Repigmentation
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2 laser abrasion with superficial full surface ablation, fractional laser treatment and conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the patient reported outcome and to assess the cellular composition of the graft.
详细描述
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. With this device an epidermal cell suspension is created from a split skin graft, usually taken from the hip region. Currently, conventional ablative (full surface de-epidermisation) laser treatment in different laser settings is used as pre-treatment to prepare the acceptor site for transplantation. There is no evidence for the laser settings used and no studies are available on the use of a fractional laser as pre-treatment in autologous cell suspension grafting using ReCell (ReCell grafting). The investigators hypothesize that more superficial conventional ablative laser treatment and fractional ablative laser treatment are as effective as the current pre-treatment, whereas these treatments are less invasive, provide faster healing and prevent side effects like persisting erythema and scars. Furthermore, infiltration anaesthesia is not necessary with these less invasive 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with, segmental vitiligo or piebaldism under medical treatment at the Netherlands Institute for Pigment Disorders
- •Patient is willing and able to give written informed consent
- •Segmental vitiligo stable since 12 months without systemic therapy or 12 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
- •At least four depigmented lesions on the proximal extremities or trunk larger than 3x3 cm or one depigmented lesion on the proximal extremities or trunk of at least 12x3 cm.
排除标准
- •UV therapy or systemic immunosuppressive treatment during the last 12 months
- •Local treatment of vitiligo during the last 12 months
- •Vitiligo lesions with follicular or non-follicular repigmentations
- •Skin type I
- •Recurrent HSV skin infections
- •Hypertrophic scars
- •Cardiac insufficiency
- •Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anaesthesia.
- •Patients who are pregnant or breast-feeding
- •Patients not competent to understand what the procedures involves
- •Patients with a personal history of melanoma or non-melanoma skin cancer
- •Patients with atypical nevi.
- •Known allergy to clarithromycin
结局指标
主要结局
Repigmentation
时间窗: 6 months after intervention
Assessment will be done by sheets and a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before and six months after treatment, after which the sheets are scanned using a predefined resolution. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch are computed.
次要结局
- PhGA(6 months after intervention)
- Side effects(6 months after intervention)
- Reepithelialization(1 week after intervention)
- Colour difference(6 months after intervention)
- PGA(6 months after intervention)
- Pain(1 week after intervention)
- Cell count(up to six hours)