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临床试验/ACTRN12611000668909
ACTRN12611000668909招募中未知

Investigation of micro-needling skin therapy for recessive dystrophic epidermolysis bullosa (RDEB) in Australia to assess median healing time of lesions

Professor Dedee Murrell0 个研究点目标入组 10 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Diagnosis of RDEB-HS (patients should have detectable low levels of collagen VII expression and reduced / abnormal anchoring fibrils on electron microscopy).
  • At least 2 symmetric wounds on each side of the body (arms, chest/abdomen, legs) of approximately the same size (at least 4 cm2 as measured accurately by the Visitrak wound measurement system [Smith & Nephew Healthcare Ltd., Hull], difference should not be more than 15%).
  • Ability to sign informed consent, which indicates the investigational nature of this study.
  • Age greater than or equal to 18.

排除标准

  • Clinical evidence of local infection of the targeted wound(s).
  • Histopathologic evidence of malignancy (i.e. squamous cell carcinoma - SCC) of the targeted wound(s).
  • Use of systemic or topical steroid therapy within 30 days before enrolment.
  • Use of any investigational drug within the 30 days before enrolment.
  • Patients considered by the investigators to be unreliable or have poor compliance
  • Patients who are pregnant, or who suspect they may be pregnant at the time of the study and lactating women. Women of childbearing age should use effective contraception.

研究者

发起方
Professor Dedee Murrell

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