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临床试验/NCT01259986
NCT01259986终止不适用

Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser

Henry Ford Health System0 个研究点目标入组 3 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
主要终点
Percent repigmentation

研究概览

简要总结

The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo.

详细描述

Vitiligo is a pigmentary disorder characterized by depigmented and hypopigmented macules and patches. There are forms of vitiligo which are more resistant to treatment, including segmental vitiligo and acral vitiligo. Previous studies have shown that a low energy helium-neon (633 nm) laser can cause increased proliferation of melanocytes and repigmentation in segmental-type vitiligo. The goal of this study is to verify these results and show efficacy in other recalcitrant forms of vitiligo including acral vitiligo and post melanocyte-keratinocyte transplantation vitiligo.

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

入选标准

  • Be at least 18 years old
  • Have active or stable segmental vitiligo on the neck or face, acral vitiligo, or have undergone recent melanocyte-keratinocyte transplantation procedure (MKTP)
  • Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection
  • Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
  • Agree to follow and undergo all study-related procedures

排除标准

  • Women who are lactating, pregnant, or planning to become pregnant
  • Patients with a recent history of melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
  • Patients with a known history of photosensitivity disorders
  • Photosensitizing medications may be continued throughout of the study at the discretion of the investigator
  • Patients with a known history of melanoma or non-melanoma skin cancers
  • Concomitant use of tanning beds
  • Any reason the investigator feels the patient should not participate in the study

结局指标

主要结局

Percent repigmentation

时间窗: 24 clinic visits over 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iltefat Hamzavi

Dermatologist

Henry Ford Health System

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