An Exploratory, Single Centre, Randomized, Placebo Controlled, Assessor Blind Clinical Trial to Assess the Effects of Intradermal Administrations of Prevascar on Scarring in Human Subjects of African Continental Ancestral Origin
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To assess the effects of Prevascar on resultant scars
研究概览
简要总结
There is considerable variation in scarring, within and between people, and between different ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. Prevascar is being developed by Renovo for use as a potential treatment for reducing scarring.
Renovo's histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month period.
It is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of scarring in Non Caucasians of African-Caribbean ancestry.
This Renovo clinical trial will be carried out primarily to establish the effects of four doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental Group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected Prevascar in wounds.
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
- Quadruple (Participant, Care Provider, 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
- •Afro-Caribbean male and female subjects between 18 and 85 years of age.
排除标准
- •Subjects who on direct questioning or examination have history or evidence of keloid scarring.
- •Subjects who have evidence of any past or present clinically significant medical condition that would impair wound healing or trial assessments
- •Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- •Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- •Female subjects who are, or who become pregnant up to and including Day 0 and/ or who are lactating.
- •In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.
研究组 & 干预措施
Group 1 - 2 doses of Prevascar and placebo
干预措施: Prevascar 250ng (Drug)
Group 2 - 2 doses of Prevascar and placebo
干预措施: Prevascar 5ng (Drug)
Group 2 - 2 doses of Prevascar and placebo
干预措施: Prevascar 25ng (Drug)
Group 2 - 2 doses of Prevascar and placebo
干预措施: Prevascar 100ng (Drug)
Group 2 - 2 doses of Prevascar and placebo
干预措施: Prevascar 250ng (Drug)
Group 1 - 2 doses of Prevascar and placebo
干预措施: Prevascar 5ng (Drug)
Group 1 - 2 doses of Prevascar and placebo
干预措施: Prevascar 25ng (Drug)
Group 1 - 2 doses of Prevascar and placebo
干预措施: Prevascar 100ng (Drug)
Group 3 - 2 doses of Prevascar and placebo
干预措施: Prevascar 5ng (Drug)
Group 3 - 2 doses of Prevascar and placebo
干预措施: Prevascar 25ng (Drug)
Group 3 - 2 doses of Prevascar and placebo
干预措施: Prevascar 100ng (Drug)
Group 3 - 2 doses of Prevascar and placebo
干预措施: Prevascar 250ng (Drug)
Group 4 - 2 doses of Prevascar and placebo
干预措施: Prevascar 5ng (Drug)
Group 4 - 2 doses of Prevascar and placebo
干预措施: Prevascar 25ng (Drug)
Group 4 - 2 doses of Prevascar and placebo
干预措施: Prevascar 100ng (Drug)
Group 4 - 2 doses of Prevascar and placebo
干预措施: Prevascar 250ng (Drug)
结局指标
主要结局
To assess the effects of Prevascar on resultant scars
时间窗: 13 months
To investigate the effects of Prevascar on wound/scar width To investigate the effects of Prevascar on wound/scar tissue histology To investigate the effects of Prevascar on scar appearance NB: This is an exploratory study and hence all objectives are exploratory
次要结局
未报告次要终点