Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Blanching of Port Wine Stain Birthmark
研究概览
简要总结
This research study was designed to determine the effect on port wine stains (PWS) of liposomal benzoporphyrin derivative monoacid (BPD-MA) termed verteporfin by intravenous (IV) infusion for photodynamic therapy (PDT) or combined PDT and pulsed dye laser (PDL) therapy (PDT + PDL). The standard treatment for PWS is PDL alone. This lightens some PWS but many lesions are not completely removed.
PDT uses a medication and light together to cause injury to a target. The medication is given and then light is directed at the desired area of treatment to achieve an effect. PDT has been used to treat some skin conditions including pre-cancers and skin cancers. Using PDT or PDT immediately followed by PDL therapy may improve PWS lightening. At this time, both PDT and PDT + PDL therapy for treatment of PWS is investigational. The type and amount of medication and light which may be used to treat PWS is not known, and is likely to be different than those used for other PDT treatments.
详细描述
Procedures will be performed at the Surgery Laser Clinic at the Beckman Laser Institute at the University of California, Irvine.
At an initial visit, a brief history and physical will be performed.
The history will include: 1) previous treatment to my PWS; 2) current medications; 3) history of light sensitivity; 4) risk of pregnancy and use of birth control in a female of child-bearing age.
The physical will include: 1) measurement and evaluation of PWS; 2) measurement of blood pressure, blood cell count, general chemistries (including liver function tests) and ANA, which might indicate an increased sensitivity to light.
On the day of treatment, the same brief physical and history will be repeated. A urine pregnancy test will be performed on females of child-bearing age.
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
- 否
入选标准
- •Adult 18 years and older
- •Have a PWS on an area other than the face
- •A negative pregnancy test and non pregnant or nursing
排除标准
- •Under 18 years of age
- •Have an allergy to verteporfin, porfimer sodium or other porphyrins
- •Have a history of porphyria (a disease that can cause sensitivity to light)
- •Have had treatment to the PWS test sites in the last 8 weeks
- •Have an active uncontrolled infection or other significant disease
- •Currently using medications that cause sensitivity to light such as tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin
- •Currently using medications that increase bleeding, including aspirin, coumadin or non-steroidal anti-inflammatory drugs
- •Have very dark skin which is sensitive to laser treatment
- •Have a positive ANA (lab tests which indicates sensitivity to light)
研究组 & 干预措施
Combined Photodynamic & Pulsed Dye Laser Treatment
Treatment of Port Wine Stains
干预措施: Combined Photodynamic & Pulsed Dye Laser Treatment (Drug)
结局指标
主要结局
Blanching of Port Wine Stain Birthmark
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
Kristen Kelly, M.D., Professor of Dermatology and Surgery
University of California, Irvine