A Double-Blind, Placebo-Controlled, Randomised Dose Ranging Trial to Investigate the Efficacy of Two Different Dosing Regimens of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- To determine the optimal concentration and dose regimen of avotermim (Juvista) for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions.
研究概览
简要总结
This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total), giving four pairs of anatomically matched wound sites per subject. Each subject acted as their own control. One site from each anatomical wound pair was randomly treated with intradermally administered avotermin (Juvista:100μL per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1, 400μL per wound site) while the second site was a paired control, treated with Placebo (100μL per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1, 400μL per wound site). Wound margins for injection were defined as extending 0.5cm from either end of the incision. Four doses of avotermin (Juvista) were administered to each subject: 5ng, 50ng, 200ng and 500ng/100μL per linear cm; one dose to one wound site per anatomically matched pair of wounds. The second wound site from each anatomically matched pair of wounds was dosed with placebo. Allocation of treatment to wound-site pairs was randomised and double blinded.
Primary objective To determine the optimal concentration and dose regimen of Juvista for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions.
Secondary objective To assess the safety and tolerance of Juvista when applied to the approximated wound margins of male and female subjects following surgical incisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 have given written informed consent.
- •Subjects with a body mass index within 15-35 kg/m2 (Quetelet's index).
排除标准
- •Subjects with history or evidence of keloid scarring.
- •Subjects with tattoos or previous scars within 3cm of the area to be incised.
- •Subjects who had surgery in the area to be incised within one year of the first dosing day.
- •Subjects with history of a bleeding disorder or who were 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 was chronic or currently active.
- •Subjects with any clinically significant medical condition or history that would impair wound healing.
- •Subjects with history of hypersensitivity to any of the drugs or dressings used in this trial.
- •Subjects taking, or who have taken, any investigational product or who had participated in a clinical trial in the three months prior to first trial dose administration.
- •Subjects 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, methamphetamines, opiates or benzodiazepines during the screening period.
- •Subjects who, in the opinion of the investigator, were unlikely to complete the trial for whatever reason.
- •Subjects who had any clinically significant neurological impairment or disease.
- •Subjects with any active infection.
- •Subjects who are pregnant or lactating.
结局指标
主要结局
To determine the optimal concentration and dose regimen of avotermim (Juvista) for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions.
时间窗: Post surgery: week 6 to Month 7
次要结局
- To assess the safety and tolerance of avotermin (Juvista) when applied to the approximated wound margins of male and female subjects following surgical incisions.(Day 0 (surgery) to Month 7 post surgery)