NCT00627536已完成2 期
A Double-Blind, Placebo-Controlled, Randomised Dose-Ranging Trial to Investigate the Efficacy of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers
Renovo1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Scar appearance
研究概览
简要总结
This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18-85 years who had given written informed consent.
- •Subjects with a body mass index within 15 to 35 kg/m
- •Subjects with clinically acceptable results for the laboratory tests
- •Female subjects of child bearing potential who are using acceptable method(s) of contraception.
排除标准
- •Subjects with history or evidence of hypertrophic or keloid scarring.
- •Subjects with tattoos or previous scars within 3cm of the area to be incised.
- •Subjects with prior surgery in the area to be incised within one year of the first dosing day.
- •Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy.
- •Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial.
- •Subjects with a clinically significant skin disorder that is chronic or currently active.
- •Subjects with any clinically significant medical condition or history that would impair wound healing.
- •Subjects with a history of drug hypersensitivity to any of the drugs or dressings used in this trial.
- •Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
- •Subjects who are taking regular, continuous, oral corticosteroid therapy.
- •Subjects undergoing investigations or changes in management for an existing medical condition.
- •Subjects with a history of drug abuse, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period.
- •Subjects who are considered unlikely to complete the trial for whatever reason.
- •Subjects with a clinically significant neurological impairment or disease.
- •Subjects with any active infection.
- •Subjects who are pregnant or lactating.
研究组 & 干预措施
1
Experimental
Avotermin 5ng/100μL/linear cm wound margin
干预措施: Avotermin (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
3
Experimental
Avotermin 50ng/100μL/linear cm wound margin
干预措施: Avotermin (Drug)
4
Placebo Comparator
Placebo matched to avotermin 50ng/100μL/linear cm
干预措施: Placebo (Drug)
5
Experimental
Avotermin 200ng/100μL/linear cm
干预措施: Avotermin (Drug)
6
Placebo Comparator
Placebo matched to avotermin 200ng/100μL/linear cm
干预措施: Placebo (Drug)
7
Experimental
Avotermin 500ng/100μL/linear cm wound margin
干预措施: Avotermin (Drug)
8
Placebo Comparator
Placebo matched to avotermin 500ng/100μL/linear cm
干预措施: Placebo (Drug)
结局指标
主要结局
Scar appearance
时间窗: 7 months
次要结局
- Safety: adverse events, local tolerability(7 months)
研究者
研究点 (1)
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