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临床试验/NCT00540371
NCT00540371已完成不适用

Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 1999年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1

研究概览

简要总结

The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port wine stain birthmarks. Involvement in the protocol will involve formal documentation of the level of treatment pain, duration of post-treatment purpura and incidence of side effects. In addition, measurements will be taken of blood substances that promote blood vessel formation/regrowth and non-invasive reflectance measurements and photographs will be taken before and after treatment.

The objective of this study is to document the degree of port wine stain lightening, the incidence of side effects and the presence of angiogenic factors induced during treatment with the pulsed dye laser in association with cooling agent. This information ultimately lead to improved treatment.

详细描述

The flashlamp-pumped pulsed dye laser has offered the best results with the lowest incidence of side effects. The yellow light is preferentially absorbed by hemoglobin allowing more selective destruction of the ectatic capillaries in the dermis.

The flashlamp-pumped pulsed dye laser has become the treatment of choice for port wine stain birthmarks; however, therapeutic challenges remain. The epidermis is not totally spared due to partial absorption of energy therein by melanin which presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

Clinical studies have demonstrated the efficacy and safety of cryogen spray cooling during pulsed laser treatment of port wine stain birthmarks. This technology allows the use of higher incident laser light dosages and has been demonstrated to improve treatment results. cryogen spray cooling also decreases treatment pain and the duration of post-laser treatment purpura.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
1 Month 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of PWS birthmark or age and sex matched control of a subject with a PWS birthmark
  • Apparent good health as documented by medical history and physical examination
  • Ability to understand and carry out subject instructions

排除标准

  • Pregnancy
  • History of cutaneous photosensitivity
  • History of photodermatoses, skin cancer or other cancer
  • Any therapy to the proposed treatment sites within the previous two months
  • Current participation in any other investigational drug evaluation
  • Concurrent use of known photosensitizing drugs
  • Inability to understand and carry out subject instructions

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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