NCT01968681已完成不适用
Treatment of Nevus Flammeus With Alexandrite Laser
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Reduction in clinical appearance on a 10-point scale
研究概览
简要总结
Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally treated with pulsed dye lasers (PDL); however, around 20 percent of patients are poor responders and do not get satisfactory results from pulsed dye laser treatments.
Small studies with alexandrite lasers indicate that this may be an alternative treatment for individuals with nevus flammeus. This study assesses the clinical effect and side effects of alexandrite laser treatment for nevus flammeus using different treatment settings.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 or more years of age
- •Fitzpatrick Skin Type I-III
- •Previously untreated or pulsed dye laser-insufficiently treated nevus flammeus
- •Nevus flammeus size minimum 8 x 2 centimeter within one anatomical region
- •Written and oral informed consent
排除标准
- •Known light sensibility toward visible light
- •Tendency to develop hypertrophic scars or keloids
- •Fitzpatrick Skin Type IV-VI
- •Individuals, that are obviously pigmented due to recent sun exposure or sun beds
- •Treatment with systemic retinoids within 6 months
- •Pregnancy and lactation
- •Unwillingness to complete protocol
结局指标
主要结局
Reduction in clinical appearance on a 10-point scale
时间窗: 6-8 weeks
次要结局
- Skin reflectance measurement to assess degree of redness(6-8 weeks)
- Skin reflectance to assess degree of pigmentation(6-8 weeks)
研究者
Merete Haedersdal
Professor
Bispebjerg Hospital
研究点 (2)
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