A Phase 1B Study to Assess the Safety and Efficacy of Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Assess the persistence and tissue compatibility with histopathology.
研究概览
简要总结
This is an early phase study comparing two fixed dose of the study compound ELAPR and a Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a 3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each injection will consist of 20-30ul of product delivered using a 30Gx¼" needle.
详细描述
Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects (including replacements) on Day 169, and from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the needle point tattoo at the centre of the implant site. The biopsy site will be closed with a single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35 to 50 years
- •Male or Female
- •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® 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®) or have the following conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia, Glucose-6-phosphate dehydrogenase deficiency or "Mollusca Contagiosa"
研究组 & 干预措施
Restylane
Patients with an even subject identification number (SIN) (02, 04, 06, 08, 10, 12, 14, 16) will have ELAPR to the right arm and the control to the left, where patients with an odd subject identification number (01, 03, 05, 07, 09, 11, 13, 15) will have the ELAPR to the left arm and the control to the right.
Patients will receive either device ELAPR002c or ELAPR002e. This will alternate to minimise bias between the right and left arms.
The first group of eight patients (01 - 08) will have their biopsy performed at day 169. The second group of eight patients (09 - 16) will have their biopsy at day 85.
干预措施: Tropoelastin (Device)
结局指标
主要结局
Assess the persistence and tissue compatibility with histopathology.
时间窗: 26 weeks
A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects on Day 169, and from Cohort B subjects on Day 85.
次要结局
- Assess the acute and chronic safety of ELAPR.(26 weeks)