ACTRN12611001205921已完成1 期
A Phase 1B study to assess the safety and efficacy of two formulations of ELAPR compared to Restylane (registered trademark) Vital light following repeat implants in the upper arm dermis in healthy volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 35 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Good general health status
- •Able to give informed consent
排除标准
- •Clinically significant abnormalities of haematology or biochemistry testing
- •Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged APTT or PT
- •Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
- •History of keloid formation
- •Systemic corticosteroids within last 12 weeks
- •Diabetes or other metabolic disorders that may interfere with the subject’s response to treatment in the opinion of the investigator
- •Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
- •Pregnancy/lactation
- •Previously received Tropoelastin
- •A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
- •Sensitivity to Restylane (Registered Trademark) Vital light or Restylane products
- •Use of any other investigational product on the intended implant site in the previous 12 months.
- •Sensitivity to topical local anaesthetic cream (EMLA(Registered Trademark)) or have the following conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia, Glucose-6-phosphate dehydrogenase deficiency or mollusca contagiosa.
研究者
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