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临床试验/NCT02154789
NCT02154789终止4 期

An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年7月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
10
试验地点
2
主要终点
cyst resolution at 6 weeks

研究概览

简要总结

Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.

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
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

  • All patients referred to dermatology in NHS Lothian or NHS Fife who have a visible Digital Myxoid Cyst affective the dital phalynx of the toes or fingers.
  • The patient must have the ability to give informed consent

排除标准

  • History of sensitivity to polidocanol or other sclerosants
  • Age less than 18
  • Inability to give informed consent
  • Inability to report side effects experienced
  • Cyst not clearly visible
  • Cyst not fluid-filled

研究组 & 干预措施

polidocanol

Experimental

干预措施: polidocanol (Drug)

cryotherapy

Active Comparator

干预措施: cryotherapy (Procedure)

infra-red coagulation

Active Comparator

干预措施: infra-red coagulation (Procedure)

结局指标

主要结局

cyst resolution at 6 weeks

时间窗: 6 weeks

Is there a difference in the percentage of participants with cyst resolution at 6 weeks post treatment in those treated with polidocanol compared to those treated with the current conventional treatments of cryotherapy and infra-red coagulation?

次要结局

  • cyst resolution at 12 and 52 weeks(1 year)
  • pain scores on a visual analogue scale(1 year)
  • procedure satisfaction on a visual analogue scale(1 year)
  • difference in scarring(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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