NCT00594581已完成2 期
A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal Juvista (Avotermin) in Male Subjects Aged 18-45 Years
Renovo1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2003年10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
- 71
- 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 safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy, male subjects aged 18 to 45 years (inclusive)
- •Body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using Quetelet's index
排除标准
- •Subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied.
- •Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial.
- •Afro-Caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring.
- •Subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease.
- •Subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial.
- •Subjects with a history of clinically significant allergies.
- •Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination.
- •Subjects taking, or who had taken, certain prescribed drugs in the 4 weeks before to Day 0 and, in particular, topical or systemic steroids, anti-inflammatory, anti-coagulant, anti-proliferative drugs, and antibiotics.
- •Subjects who have taken part in a clinical trial within 3 months before admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not.
- •Subjects with any clinical evidence of severe ongoing, or prolonged, depression or mental illness.
- •Subjects smoking more than 20 cigarettes a day.
- •Subjects drinking more than 28 units of alcohol per week (1 unit = ½ pint of beer [285ml], 25ml of spirits, or 1 glass of wine).
- •Subjects showing evidence of drug abuse.
- •Subjects known to have, or to have had, serum hepatitis or who were carriers of the hepatitis B surface antigen (HbsAg) or hepatitis C antibody.
- •Subjects previously testing positive for HIV antibodies, or who admit to belonging to a high-risk group.
- •Subjects with pre-existing clinically significant neurological conditions.
- •Subjects who, in the opinion of an investigator, are not likely to complete the trial for whatever reason.
研究组 & 干预措施
1
Active Comparator
Juvista (avotermin) 50ng/100μl/linear cm wound margin
干预措施: Juvista (avotermin) plus placebo, standard-care (within-subject controls) (Drug)
2
Active Comparator
Juvista (avotermin) at 200ng/100μl/linear cm
干预措施: Juvista (avotermin) plus placebo, standard-care (within-subject controls) (Drug)
结局指标
主要结局
Scar appearance
时间窗: 12 months
次要结局
- Safety: adverse events, local tolerability, systemic exposure(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
EUS-RFA PANCARDINAL-1 TrialPancreatic Ductal Adenocarcinoma (PDAC)NCT04990609The University of Texas Health Science Center, Houston60
已完成
2 期
Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With SulfonylureaType 2 Diabetes MellitusNCT00455598Ionis Pharmaceuticals, Inc.88
已完成
2 期
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular CarcinomaHepatocellular CarcinomaNCT05864105Biotheus Inc.35
已完成
不适用
A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.Irritable Bowel SyndromeNCT06687720NovoBliss Research Pvt Ltd18
已完成
2 期
A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid RecurrenceKeloidNCT04844840Sirnaomics29