A Single-site, Placebo-controlled, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and the Scar-improvement Efficacy of Intradermal Applications of Three Doses of Juvidex (5.64mg/100μl, 2.82mg/100μl and 11.28mg/100μl) Given Once Only or Three Times Within and Between Male and Female Subjects Aged 18-45.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only and three times in male and female subjects.
研究概览
简要总结
The purpose of this study was to investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only or three times in male and female subjects and to collect further safety and tolerability data for intradermal Juvidex in male and female subjects.
详细描述
Subjects were randomised into three dose groups of equal size. The three dose groups were 100mM (2.82mg/100μl), 200mM (5.64mg/100μl) and 400mM (11.28mg/100μl). Before wounding, three prospective wound sites 1cm long were marked on the upper, inner aspect of each arm (anterior, posterior and distal) to give three pairs of wounds. Wounds were assigned as Pair 1 (left distal and right distal), Pair 2 (left anterior and left posterior) and Pair 3 (right anterior and right posterior).
Sites were anaesthetised using 1% plain lignocaine, then prior to wounding one site from each pair, randomly assigned, received an intradermal injection of Juvidex (100μl) and the opposite site from each pair received an intradermal injection of Placebo (100μl).
Within dose groups, subjects were randomised into two subgroups of similar size. Subgroup A received one dose in wound pairs 1 and 2; and three doses in wound pair 3. Subgroup B received three doses in wound pairs 1 and 2; and one dose in wound pair 3. Incision sites randomised to receive three injections of study medication were re-dosed with 100μl per wound margin (200μl per site) 3 hours after receiving the first dose and dosed again in the same way on Day 5.
Subjects attended a follow-up visit on Day 14. Scars were assessed monthly from Month 1 to Month 12. At Month 12, the Investigator excised the distal scars from each subject for histological examination. Posttrial follow-up visits are scheduled for Months 18 and 24.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18-45 years who gave written informed consent
- •Weight between 50-150kg with a BMI within the permitted range for their height using Quetelet's index: weight (kg)/height (m)
- •The permitted range was 15-55kg/m2
- •Female subjects of childbearing potential who were deemed by the Investigator to be using adequate contraception at the time of screening and who agreed to continue using this form of contraception for the duration of the trial
- •In the opinion of the Investigator, and on the basis of the investigations carried out within 12 weeks prior to the first study drug dose (determined by results of electrocardiogram [ECG], physical examination, medical history, haematology and biochemistry blood results) the subject was in adequate health to undertake the trial
排除标准
- •Subjects who on direct questioning and physical examination had a history or evidence of hypertrophic or keloid scarring or had tattoos in the area to be incised
- •Afro-Caribbean subjects because of their increased susceptibility to hypertrophic and keloid scarring
- •Subjects who had surgery in the area to be incised within one year of the first dosing day
- •Subjects with a history of a bleeding disorder
- •Subjects who, on direct questioning and physical examination, had evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, immuno-mediated conditions and skin diseases and allergies, such as clinically significant eczema
- •Subjects with a skin disorder that was chronic or currently active and which the Investigator considered would adversely affect the healing of the acute wounds or would involve the areas to be examined in this trial
- •Subjects with any clinically significant medical condition that would impair wound healing including; significant rheumatoid arthritis, chronic renal impairment significant for their age, significant hepatic impairment (LFTs >3 times upper limit of normal), congestive heart failure, current active malignancy or history of malignancy in the last 5 years, immunosuppression or chemotherapy within the last 12 months, a history of radiotherapy and diabetes mellitus
- •Subjects with a history of clinically significant drug hypersensitivity to lignocaine or an allergy to surgical dressings to be used in this trial
- •Subjects who were taking or had taken any investigational product or participated in a clinical trial within the three months prior to first study drug dose for this trial
- •Subjects who were taking regular, continuous, oral corticosteroid therapy
- •Subjects who, in the opinion of the Investigator, were not likely to complete the trial for whatever reason
- •Subjects who were, or who became, pregnant or were lactating, up to and including the time of the first dose of study drug
- •Subjects undergoing/awaiting investigations or change in management for an existing medical disorder
- •Subjects who had evidence of drug abuse
研究组 & 干预措施
Placebo (vehicle)
干预措施: Placebo (Drug)
Intradermal Juvidex
干预措施: Juvidex (Drug)
结局指标
主要结局
To investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only and three times in male and female subjects.
时间窗: 12 months
次要结局
- To collect further safety and tolerability data for various doses and dosing frequencies of intradermal Juvidex in male and female subjects.(1 hour to 24 months)
- To assess systemic exposure to Juvidex, following various doses and dosing frequencies of intradermal Juvidex, before and after making minor skin incisions in male and female subjects.(1 hour to 12 months)