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临床试验/NCT01087216
NCT01087216已完成2 期

Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy

研究概览

简要总结

The treatment of vitiligo remains disappointing especially in some localization such as bony prominences and extremities. The association of UVB and topical steroids has been proven to be synergistic but the results are still insufficient in those difficult to treat areas. Promising results have been shown with the combination of laser assisted dermabrasion, topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin followed by topical steroids should potentialized the effect of UVB and be superior to topical steroids and UVB without dermabrasion.

The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion combined to topical steroids and UVB phototherapy in difficult to treat areas.

Patients with symmetrical non segmental vitiligo will be included in this prospective randomized monocentrer study. The investigators calculated the number of patients needed at 25. The side that will receive the dermabrasion will be centrally randomized and the opposite side will serve as control. Then on both side class 3 topical steroids will be applied daily 3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.

The evaluation will be performed by two independent physician blinded to the treatment of standardized photos before and 1 month after the end of the treatment. The criteria of success will be at least 75% of repigmentation.

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 (Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 at 85
  • Not segmental Vitiligo of clinical diagnosis located on bony projections or of ends
  • Two symmetrical plates of vitiligo of more than 4 cm ²

排除标准

  • Pregnant women or breastfeeding.
  • Vitiligo lesions on face and neck
  • Personal history of skin cancer
  • Photosensitize drugs
  • Personal history of photodermatosis
  • Personal history of keloids
  • Concomitant treatment that could have an action on vitiligo (such as tacrolimus or pimecrolimus).

研究组 & 干预措施

Group Laser = Arm As A

Active Comparator

Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy

干预措施: Group Laser = Arm A (Device)

结局指标

主要结局

Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy

时间窗: 4 months

Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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