RPCEC00000061已完成2 期
Application of CIGB-128 in keloid patients undergoing surgical exeresis.
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 45 人开始时间: 2010年12月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •1) Age: 18 to 75. 2) Lesions on any location, regardless of progression time. 3) Patient’s consent in writing. 4) Clinical and histological diagnosis. 5) Lesion size ranging from 0.5 to 10 cm. 6) No antifibrotic treatment up to 6 months before inclusion.
排除标准
- •Hypertrophic scars. Pregnancy or breastfeeding. Hypersensitivity to CIGB-128 or other preparations used in the study. Acute or chronic liver condition (twice the normal TGP and TGO values and/or total bilirubin >17 micromol/L). Acute or chronic kidney condition. Uncontrolled heart failure. Severe hematological disorders. Severe psychiatric disorder or any other condition preventing the patient from giving consent or making it difficult to conduct evaluations. Diabetes mellitus. Patients who have been on any other antifibrotic treatment in the last 6 months before inclusion.
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