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临床试验/NCT03497208
NCT03497208Unknown不适用

Comparative Study of Surgical Treatment of Vitiligo: Microneedling Versus Microneedling With Suspension of Uncultured Epidermal Cells

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Evaluate the repigmentation of vitiligo lesion

研究概览

简要总结

A comparative study for the surgical treatment of vitiligo in which the same patient will receive in acromic and symmetric lesions of vitiligo dermabrasion with micro needling and on the other side dermabrasion with micro needling followed by the application of cell suspension (melanocytes and uncultured keratinocytes). These cells will be removed from the own patient through the skin of the scalp. After the surgical procedure, patients will be submitted to UVB-NB phototherapy sessions (twice a week) and evaluated for repigmentation of vitiligo lesions at 14 and 24 weeks of treatment.

详细描述

Background: Vitiligo is characterized by a depigmentation acquired with partial or total loss of melanocytes from the epidermis, causing great psychosocial impact. Several therapeutic modalities have been proposed for its treatment and surgical treatments have been shown to be promising, especially in recalcitrant cases. The technique of epidermal rasping grafting, a variant of the punch micrografts technique, shows high repigmentation rates and does not require high cost technology. Objective: The objective of this project is to perform a comparative study for the surgical treatment of vitiligo, in which the same patient (N = 10) will receive, in symmetrical acrylic areas, only dermabrasion with a micro needling of 0.25 mm or dermabrasion using micro needling followed of the cell suspension application (melanocytes and uncultured keratinocytes). Methodology: In the donor area (scalp) the healthy tissue will be removed. This tissue will be placed in a sterile container with physiological saline and fragmented with delicate scissors for about 20 minutes until homogeneous consistency of the material is obtained. After the enzymatic digestion of epidermal cells of the dermis, it will isolate melanocytes and keratinocytes that will be placed in the recipient area. After 15 days of the surgical procedure, patients will start the phototherapy UVB-NB sessions (twice a week). The patients will be evaluated about the pain during the procedure, the improvement of injuries of vitiligo and the vitiligo-specific quality-of-life instrument (VitiQoL Vitqol Index) will be applied after and before the treatment. Conclusion: The technique of grafting by epidermal scrap shows high rates of repigmentation and does not require high cost technology, which motivated us, in this study, corroborating the literature and helping to disseminate this technique.

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
14 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 14 years old
  • Patients in treatment in the Dermatology Service HCPA
  • Patients able to do UVB - NB phototherapy
  • Patients with stable vitiligo lesions more than 1 year

排除标准

  • Under 14 years old
  • Patients unable to do phototherapy UVB-NB
  • Unstable vitiligo lesions less than 1 year
  • Patients with immunodeficiency (diabetes, infection, use of immunosuppressive drugs)
  • Pregnancy and lactating
  • Phototherapy session less than 2 months
  • Patients with some kind of allergy about the drugs that will be used (like lidocaine anesthetic cream or chlorhexidine antiseptic)
  • Patients using photosensitizing drugs
  • Patients with keloids history, Hypertrophic scar or post inflammatory Hyperpigmentation.

研究组 & 干预措施

Microneedling+cell susp+phototherapy

Experimental

Experiment is about the use of abrasion technic with dermaroller, equipped with a 0,25mm needle, applied on a vitiligo lesion. After that, a transplant with non cultured cell suspension (melanocytes and keratinocytes) will be applied to pacient 's skin scalp.

干预措施: Microneedling (Procedure)

Microneedling+cell susp+phototherapy

Experimental

Experiment is about the use of abrasion technic with dermaroller, equipped with a 0,25mm needle, applied on a vitiligo lesion. After that, a transplant with non cultured cell suspension (melanocytes and keratinocytes) will be applied to pacient 's skin scalp.

干预措施: Cell suspension (Procedure)

Microneedling+cell susp+phototherapy

Experimental

Experiment is about the use of abrasion technic with dermaroller, equipped with a 0,25mm needle, applied on a vitiligo lesion. After that, a transplant with non cultured cell suspension (melanocytes and keratinocytes) will be applied to pacient 's skin scalp.

干预措施: Phototherapy (Radiation)

Microneedling and phototherapy

Active Comparator

Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo.

干预措施: Cell suspension (Procedure)

Microneedling and phototherapy

Active Comparator

Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo.

干预措施: Phototherapy (Radiation)

结局指标

主要结局

Evaluate the repigmentation of vitiligo lesion

时间窗: The measure will be made in 24 weeks after the procedure

Through a transparent millimeter paper the vitiligo area will be measure

次要结局

  • Pain index(6 months)
  • Vitiligo-specific quality-of-life instrument (VitiQoL).(6 months)
  • Index of satisfaction(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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