EUCTR2005-003889-42-GB进行中（未招募）不适用
A double blind, placebo controlled, randomised trial to investigate the efficacy of Juvista in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following scar revision surgery. - Juvista in the prevention or reduction of the resultant scar following scar revision surgery.
Renovo0 个研究点开始时间: 2005年9月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects aged 18-85 years who have provided written informed consent
- •A body mass index between 15 and 35 kg/m2
- •Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol.
- •Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator
- •Subjects with linear scars that are suitable for revision by excision and direct closure.
- •Subjects who have stabilised, mature scars
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who have history or evidence of keloid scarring.
- •Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar.
- •Subjects with additional scars less than 3cm away from the area to be revised.
- •Subjects with a history of a bleeding disorder.
- •Subjects with diseases or conditions that could interfere with assessment of safety, tolerability or efficacy.
- •Subjects who have had surgery in the area to be excised within one year of Day 0.
- •Subjects with a skin disorder which could affect the healing of acute wounds.
- •Subjects with evidence of past or present medical condition that would impair wound healing.
- •Subjects with hypersensitivity to any drug or dressing in trial.
- •Subjects who are taking, or have taken, any investigational drugs including Juvista within 3 months of screening.
- •Subjects taking regular, continuous, oral corticosteroids.
- •Subjects with psychiatric disorders.
- •Subjects undergoing investigations or changes in management for an existing medical condition.
- •Subjects who are or become pregnant up to and including Day 0 or who are lactating.
- •Subjects who are not likely to complete the trial.
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