ACTRN12612000320853已完成1 期
A Phase 2 bilateral (split-face) comparison study to assess two formulations of ELAPR (Tropoelastin) compared to Juvederm (Registered trademark) Ultra Plus for the treatment of moderate to severe nasolabial folds in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
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
- 25 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Moderate to severe Nasolabial folds scored using the Winkle Severity Rating Scale graded equally as a 3 or 4 out of 5 on both sides of the face
- •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
- •Over the counter neutraceuticals and health supplements which may increase risks of bruising (e.g. chilli or capsicum)
- •Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
- •Allergy to local anaesthetics
- •Systemic corticosteroids within last 12 weeks
- •Active infection at the treatment site
- •Treatment of either NLF other than with a hyaluronic acid (HA) dermal filler and treatment with a HA dermal filler within 18 months of enrolment
- •Any treatment with Botulinum toxin that in the investigator’s opinion may impinge on the appearance of the NLF treatment site
- •Mid and Lower face volumising treatments which in the view of the investigator may impinge on the appearance of the NLF region
- •Treatments to the implant site involving significant tissue ablation including lasers, dermabrasion and high strength chemical peels
- •Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
- •Pregnancy/lactation
- •History of keloid formation
- •Unstable Diabetes or metabolic disorders
- •A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
- •Sensitivity to Juvederm (Registered Trademark) Ultra Plus or Juvederm (Registered Trademark) products.
- •Participation in any other clinical trial one month prior to treatment and for the duration of the study.
研究者
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