A Phase 2 Bilateral (Split-face) Comparison Study to Assess Two Formulations of ELAPR Compared to Juvéderm® Ultra Plus for the Treatment of Moderate to Severe Nasolabial Folds
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Assess the effect of two formulations of ELAPR on change from baseline of the severity of the Nasolabial folds against a Wrinkle Assessment Scale of Nasolabial folds score at 24 weeks vs. active control
研究概览
简要总结
Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.
详细描述
The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve optimum cosmetic results (OCR).
Each treatment will consist of up to 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each Nasolabial fold using a 27G needle.
Each patient will receive the same preparation implanted as a bolus of 0.1mL at Day 1 into the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27G needle, and two 2mm biopsies will be taken at the same visit on Day 57, Day 85 or Day 169 depending on randomisation for histopathology assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 25 - 65 years
- •Male or Female
- •Moderate to severe NLFs scored equally as a 3 or 4 out of 5 on both sides of the face using the WAS scale
- •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 bleeding time
- •Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
- •Allergy to local anaesthetics
- •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 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
- •Systemic corticosteroids within last 12 weeks
- •Diabetes or metabolic disorders
- •A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
- •Sensitivity to Juvéderm® Ultra Plus or Juvéderm® products.
- •Participation in any other clinical trial one month prior to treatment and for the duration of the study.
结局指标
主要结局
Assess the effect of two formulations of ELAPR on change from baseline of the severity of the Nasolabial folds against a Wrinkle Assessment Scale of Nasolabial folds score at 24 weeks vs. active control
时间窗: 24 weeks
The primary efficacy variable is the change in Wrinkle Assessment Scale (WAS). The values for WAS recorded at each visit will be summarized by treatment.
次要结局
- Assess the acute safety of ELAPR(24 weeks)
- Assess chronic safety of ELAPR(24 weeks)