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临床试验/NCT01924273
NCT01924273已完成1 期

Novel Treatment for Port Wine Stain Birthmarks

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
7
试验地点
1
主要终点
Port wine stain blanching

研究概览

简要总结

Port wine stains Birthmark are congenital, progressive vascular malformations of the skin that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds of these malformations occur on the face. Personality development of virtually all patients is adversely affected as a result of the negative reaction of others to a "marked" person. Detailed studies have documented lower self-esteem and difficulties with interpersonal interactions in Port wine stains patients. Port wine stains are initially flat and red, but with time, they tend to darken to purple and become thickened as vascular nodules develop. This thickening occurs in approximately two-thirds of lesions and further disfigures the facial features of many patients.

详细描述

Pulsed dye laser is currently the standard of care treatment for Port wine stains. Researchers at University of California Irvine at Beckman Laser Institute Medical Clinic can use Photodynamic therapy, another treatment option for Port wine stains. Photodynamic therapy involves light activation of a photosensitizer (a drug that is responsive to light or radiant energy). Because the photosensitizer can be localized to a desired portion of the Port wine stain, Photodynamic therapy creates an opportunity for targeted destruction of Port wine stains.

Researchers will use a photosensitizer medication called Talaporfin sodium, an intravenously administered investigational photosensitizer, being evaluated for multiple clinical indications. Photodynamic therapy with talaporfin sodium has been investigated for many different conditions, and can be used for treatment for Port wine stains. Photosensitivity precaution instructions will be provided, including appropriate photo protective clothing, protective hat and sunglasses that wrap around the temples to help minimize lateral sun light exposure when traveling home following discharge from the study site.

For efficacy, evaluated study variable will be Port wine stain blanching, and the researchers can use diffuse reflectance imaging chromametry, Laser Speckle Imaging and Spatial Frequency Domain Imaging to measure the change of Port wine stain blanching. The maximum power of the Laser Speckle Imaging and Spatial Frequency Domain Imaging light source is 10-50 mW, which is comparable to halogen-bulb household flashlights. Efficacy will be evaluated based on comparison of pre-treatment visit and post treatment day 1, week 1, week 4, and week 12 measurements.

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

  • Male/Female 18 years and older
  • Have Port Wine Stain Birthmarks non-facial

排除标准

  • Under 18 years of age
  • No Port Wine Stain Birthmarks
  • pregnant/breast feeding

研究组 & 干预措施

Port Wine Stain Birthmarks

Other

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

干预措施: Talaporfin sodium (Drug)

结局指标

主要结局

Port wine stain blanching

时间窗: up to 12 weeks

The outcome measure will be PWS blanching as assessed by Diffuse Reflectance Imaging/Laser Speckle Imaging/Spatial Frequency Domain Imaging.

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

Beckman Laser Institute and Medical Center

Kristen Kelly M.D.,Professor Departments of Dermatology and Surgery

University of California, Irvine

研究点 (1)

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