Transplantation With Dermarolling System of Basal Cell Layer Suspension Obtained by Soft Trypsinisation in Vitiligo Lesion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of repigmentation lesions
研究概览
简要总结
Actually the methods for melanocyte delivery are invasive and often sophisticated. The dermarolling system with needles causing tiny microinjuries in the epidermis could offer a minimally invasive and painless method of melanocyte transplantation. The purpose of the study is to develop a new and simple method for transepidermally delivering keratinocytes and melanocytes into vitiligo skin.
详细描述
Condition: stable lesion of non segmental and segmental vitiligo of adults.
Background: The best method to transepidermally deliver isolated cells (melanocytes) is not yet defined. Microneedle treatment of the " ex vivo " human skin caused many thin vertical epidermodermal fissures and a variable depth of injury into the dermis regarding the length of the needles. This kind of treatment could be able to create small epidermal defects which allows to deliver melanocytes to an epidermal site. An approach to replenish melanocytes by injection of dissociated epidermal cell suspension with a syringe was recently successfully used. So, we hypothesize that the use of dermaroller with 0.2mm needle length which causes tiny microinjuries strictly in the epidermis could offer a simple, minimally invasive and painless method of melanocyte transplantation.
Main objective: To demonstrate the efficacy and the interest of dermaroller use with 0.2mm needle length in the transplantation of basal cell layer suspension in the epidermis of depigmented vitiligo skin.
Secondary objectives
- To assess as control the effect of the use of dermaroller alone on the vitiligo lesion.
- If transplantation is successful, to assess the duration needed to obtain a good coalescence and a complete repigmentation of the vitiligo lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Non segmental and segmental vitiligo lesions stable for a minimum of 1 year prior surgery
- •Men and women aged over 18 years of age
- •The lesion area must be 2cm2< lesion< 15cm2
- •Absence of infected lesion
排除标准
- •Actively spreading vitiligo (unstable disease)
- •Patient with history of melanoma
- •Infected lesions
- •Positive Koebner Phenomenon
- •History of hypertrophic scars or keloid formation
- •Treatment with immunosuppressive or cytotoxic medication the past year
- •Pregnant women and patients aged less 18 years
- •Patients with concomitant photosensitizing treatment
- •Positive serology of herpes, HIV, hepatitis B and C
研究组 & 干预措施
single arm study
Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion.
干预措施: Dermabrasion with dermaroller (Device)
结局指标
主要结局
Rate of repigmentation lesions
时间窗: At 6 months
Image analysis
次要结局
- Global satisfaction expressed by the patient(At 6 months)
研究者
BENZEKRI LAILA
PhD
Mohammed V Souissi University