Clinical Efficacy of Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Disappearance of the telangiectasia
研究概览
简要总结
Using of low concentrate sodium tetradecyl sulfate for sclerotherapy of telangiectasias should be no less effective than hypertonic glucose, and have a comparable frequency of adverse events.
详细描述
For sclerotherapy of telangiectasias are used detergents. These are aggressive substances, which have a high frequency of adverse events. According to histological studies the safest concentration for the treatment of telangiectasias is less than that specified in the official instructions. The concentration of sodium tetradecyl sulfate 0.15% was effective and did not cause any adverse reactions in the treatment of telangiectasias from 0.8 to 1 mm in diameter. Small telangiectases (0.5 mm or less) require the treatment with the less aggressive sclerosing agent. Perhaps, the sodium tetradecyl sulfate 0.15%, 0.1% or even 0.05% and hypertonic glucose may be more effective and safe in this situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women over 18
- •single primary or secondary telangiectasias unrelated to the reticular veins
- •signed informed consent to participate in the study
排除标准
- •telangiectasias associated with reticular veins
- •diabetes mellitus
- •pregnancy or lactation
- •malignant neoplasms
- •inability or unwillingness of the patient to wear compression stockings
- •hypersensitivity to one of the drugs
- •concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena, known hereditary thrombophilia.
- •period after treatment of alcoholism
- •reception of oral contraceptives
- •sedentary lifestyle
研究组 & 干预措施
hypertonic glucose
- to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm.
- to measure the maximum diameter of telangiectasia using the Dermatoscope scale.
- to inject the 75% glucose, with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
干预措施: Sclerotherapy (Procedure)
0.05% sodium tetradecyl sulfate
- to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm.
- to measure the maximum diameter of telangiectasia using the Dermatoscope scale.
- to inject the 0.05% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
干预措施: Sclerotherapy (Procedure)
0.1% sodium tetradecyl sulfate
- to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm.
- to measure the maximum diameter of telangiectasia using the Dermatoscope scale.
- to inject the 0.1% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
干预措施: Sclerotherapy (Procedure)
0.15% sodium tetradecyl sulfate
- to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm.
- to measure the maximum diameter of telangiectasia using the Dermatoscope scale.
- to inject the 0.15% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
干预措施: Sclerotherapy (Procedure)
结局指标
主要结局
Disappearance of the telangiectasia
时间窗: 2 months
The clearing of the vessels on the six-point scale (from 0 to 5 points): 5 - total disappearance of the matting (100% efficacy), 4 - disappearance of around 80%, 3 - disappearance of around 60%, 2 - disappearance of around 40%, 1 - disappearance of around 20%, 0 - no changes.
次要结局
- Pain during the procedure: visual analog scale(immediately after the procedure)
- Patient Satisfaction After Treatment(2 months)
研究者
Oksana Bukina
Director, Clinical Research
Derzhavin Tambov State University