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