Comparison of the Efficacy of Micro-holes vs. Laser-assisted Dermabrasion, for Repigmenting in Vitiligo Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- Rate of repigmentation lesions
研究概览
简要总结
Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo.
A total of 10 patients with stable non-segmental vitiligo will be included in the ITT population.
In each patient, three separate test areas will be selected in the same part of the body.
One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension alone and the two others will receive the epidermal cell suspension in hyaluronic acid after pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his own control.
Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week after cell grafting.
详细描述
Condition Stable lesion of Vitiligo of adulthood
Background Laser-assisted dermabrasion is the gold standard for preparing the grafting bed of epidermal suspension but it requires a technical platform and a trained physician. Side effects are not uncommon. We have demonstrated in an ex vivo study that micro-needles create holes in the epidermis allowing cells to reach the lower layers of the epidermis. We hypothesize that the use of micro-needles could be an effective and easy technique for preparing the grafting bed for epidermal suspensions.
Objectives Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo.
The secondary objectives are
- To evaluate and compare the tolerability of the distinct procedures
- To evaluate the global satisfaction of patient and the willingness to reproduce the procedure for treating other areas
- To evaluate the contrast between treated skin and perilesional area
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years old with a diagnosis of non-segmental lesions that has been stable over three months
- •The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.
- •For each patient the lesions are located on the same area (either chest, back, legs or arms)
- •The lesion area must be: 2cm2 < lesion<50cm2
- •Treatment resistant areas (failure of at least one medical procedure topical tacrolimus or topical steroids for 6 months).
- •Absence of infected lesion
- •Lesions stable for at least one year
排除标准
- •Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
- •Indication against biopsies
- •Patient with a history of melanoma
- •Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C)
- •History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
- •Infected lesion
- •Patient with concomitant photosensitizing treatment
- •Age <18 years
- •Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent
- •Pregnant,delivering or lactating patients. For the women childbearing potential, a urinary pregnancy test will be done and effective contraception will be expected.
结局指标
主要结局
Rate of repigmentation lesions
时间窗: at 3 months
Rate of repigmentation lesions at 3 months
次要结局
- -Contrast between treated and perilesional area (Nottingham scale)(at 3 months)
- Global satisfaction expressed by the patient(at 3 months)
- EVA scale(During the procedure)