NCT03948997已完成不适用
The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
xjpfW0 个研究点目标入组 80 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Exon mutation sequences and mutation frequencies
研究概览
简要总结
- Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin involving the superficial vascular plexus that occurs in estimated 3-5 children per 1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken progressively to purple and, by middle age, often become raised as a result of the development of vascular nodules. Because most malformations occur on the face, PWS is a clinically significant problem in the majority of patients.
- The late-stage cobblestoning appearance of PWS subjects is comprised by not only pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous abnormalities. Despite these histologic observations, the specific mechanisms involved in PWS nodular formation remains unclear.
- In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in both hypertrophic areas and nodules within the lesion. These observations led us to hypothesize that the PI3K pathway may play an important role in nodular formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Month 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 month - 70 years old, male or female;
- •The patient and the family of the child agreed to participate in the experiment and signed an informed consent form;
- •Clinical diagnosis of refractory port wine stains with thickened nodular or PDL resistance; .There is no bleeding, ulceration, infection, etc. affecting the visual field of laser surgery operation.
排除标准
- •Patients with severe infectious diseases;
- •Heart disease patients;
- •Epilepsy patient;
- •Pregnant patient;
- •Researchers believe that patients who are not suitable for this experiment
结局指标
主要结局
Exon mutation sequences and mutation frequencies
时间窗: Baseline (before treatment)
In patients with nodular port wine stains, the exon mutation sequence and mutation frequency were compared between normal skin tissue (or blood), erythema and nodular tissue of the same patient.
次要结局
- Changes in the levels of cytokines in serum and skin tissues(baseline (before treatment) and 1, 3, 7 days after treatment)
研究者
xjpfW
Head of Dermatology
Xijing Hospital
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