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
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