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临床试验/NCT05771311
NCT05771311招募中不适用

Potassium Tetanyl Phosphate Laser vs Pulsed Dye Laser for Treating Port-Wine Stains - A Prospective, Split-Side Study

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
area reduction

研究概览

简要总结

To compare the efficacy and safety of 532nm KTP laser and 585 nm pulsed dye laser for treating port-wine stains.

详细描述

Nevus flammeus is a vascular, primarily capillary malformation visible from birth on. In rare cases, it may also affect venous and/or arterial vascular systems of the skin or other organs [1]. It occurs in 0.3%-0.5% of the population [1], i.e. in about 3-4 out of 1000 newborns, and is thus the most frequent vascular malformation in children. The cause is a permanent dilatation of the capillary vessels, which is caused by a lack of sympathetic nerve fibers or a lower density of the same.

First-line therapy of port-wine stains consists of laser treatment with the long-pulsed dye laser [2] with a wavelength of 595nm. Treatment must be performed at least 10 times at intervals of about 8 weeks and leads to lightening and reduction of lesions. In recent years, problems have often arisen in care of port-wine stain patients because dye lasers often failed due to the instability of technology, resulting in treatment delays. Novel long-pulsed KTP lasers may be a sufficient alternative to pulsed dye lasers in treatment of port-wine stains.

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
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

  • Men and women 18 years and older
  • Good general health, no relevant previous diseases
  • Presence of one or more port-wine stains
  • Cognitive ability and willingness to give consent (Informed Consent)

排除标准

  • Age < 18 years
  • Pregnant and breastfeeding women
  • Significant open wounds or lesions in the region to be treated
  • Missing consent and/or data protection declarations

结局指标

主要结局

area reduction

时间窗: at follow-up visit 6 weeks after last treatment session

measurement using photo documentation

Erythema

时间窗: at follow-up visit 6 weeks after last treatment session

assessment scale 1 - 7 (normal skin - dark purple) evaluated by physician and blinded investigator

次要结局

  • patient satisfaction(at follow-up visit 6 weeks after last treatment session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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KTP Laser vs Pulsed Dye Laser for Port-Wine Stains | 临床试验