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临床试验/NCT00791908
NCT00791908已完成不适用

Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata

Northwestern University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2006年9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
15
试验地点
2
主要终点
Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters

研究概览

简要总结

The primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject.

The investigators hypothesize that the two laser treatments will be an effective tool for treating cherry angiomas. The investigators aim to compare these modalities to electrodessication, as all three modalities are considered the current standard of care. Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.

In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of care, electrodessication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 95 years.
  • Have at least 12 cherry angiomas (4 per each third of the torso) that have been documented.
  • The subjects are in medically stable condition.
  • The subject has willingness and the ability to understand and provide informed consent for the procedure and is able to communicate with the investigator.
  • Must be willing not to employ other treatment options for cherry angiomas during the course of this study.

排除标准

  • Under 18 years of age and over 95 years of age
  • Pregnancy or lactation.
  • Subjects who are unable to understand the protocol or to give informed consent.
  • Subjects cannot have had previous laser treatment in the last 6 months before enrollment.
  • Subjects have a cardiac defibrillator or pacemakers that may interact with the electrodesiccation technique.
  • Subjects have no serious medical conditions that would contradict participation in the research.

结局指标

主要结局

Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters

时间窗: Baseline and 3 months

Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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