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UVA 1 Phototherapy for Vitiligo

2015年6月30日 更新者：University of British Columbia
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Ultraviolet A1 (UVA1) phototherapy has been shown to be useful for a variety of skin diseases. However, there are only a few studies published on the efficacy of UVA1 in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.

研究概览

地位

未知

条件

干预/治疗

详细说明

Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.

There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Narrow-band UVB (NB-UVB) is currently the preferred treatment over topical psoralen and ultraviolet A radiation (PUVA), for patients with vitiligo. However, overall response of vitiligo to NB-UVB has been variable. Ultraviolet A1(UVA1) phototherapy is now useful for a variety of skin diseases, specifically scleroderma. There are only a few studies published on the efficacy of UVA1 in vitiligo.

One of the main side effects of UVA1 is prominent tanning which might be due to melanocyte stimulation. Therefore, the investigators hypothesis is that UVA1 will induce significant skin pigmentation to improve vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.

Study Objectives

  1. To evaluate the potential for UVA1 to induce repigmentation within vitiligo patches.
  2. To assess the side effect profile of UVA1 when used in the treatment of vitiligo.

研究类型

介入性

注册 (预期的)

16

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E8
        • 招聘中
        • The Skin Care Center, Vancouver General Hospital
        • 首席研究员：
          • Harvey Lui, MD FRCPC
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age > 18 years.
  • Localized or generalized vitiligo that involves a non mucosal or acral site.
  • Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually

Exclusion Criteria:

  • Patients who received treatment for vitiligo within the past 3 weeks.
  • Patients known to have a photosensitivity disorder
  • History of previous skin cancer.
  • History of severe medical illness or immunosuppression.
  • Pregnancy or breast-feeding.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：无治疗（覆盖）
有源比较器：UVA1
程序：UVA1

Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into two halves. One half will be shielded by foil and served as control while the other half will be exposed to UVA1.

The dose of UVA1 will be 60 J/cm2, 5 times a week for 4 weeks. Patients that have no or less than 10% pigmentation change after 4 weeks will receive UVA1 130J/cm2, 5 times a week for another 4 weeks. The patients with more than 10% pigmentation change will receive UVA1 60 J/cm2, 5times a week for another 4weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change in the modified VASI score compared to baseline.
大体时间：assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment

次要结果测量

结果测量
大体时间
Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption
大体时间：assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of British Columbia

调查人员

  • 首席研究员：Harvey Lui, MD, FRCPC、University of British Columbia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年2月1日

初级完成 (预期的)

2015年12月1日

研究注册日期

首次提交

2013年2月4日

首先提交符合 QC 标准的

2013年2月6日

首次发布 (估计)

2013年2月11日

研究记录更新

最后更新发布 (估计)

2015年7月2日

上次提交的符合 QC 标准的更新

2015年6月30日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • H10-02235

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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赞助者/合作者

地点

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