The Use of a Recombinant DNA-based Hyaluronidase (RDNAH/ Hylenex Recombinant) to Dissolve Fixed Amounts of a Variety of Popular Hyaluronic Acid (HA) Dermal Fillers in Human Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)
研究概览
简要总结
The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA) dermal fillers.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 years of age or older
- •Able to speak/write in the English language
- •Negative Pregnancy Test on Day 1
- •Proposed injection site must be free of any active inflammation
排除标准
- •Pregnant or breast feeding
- •History of keloid formation
- •History of allergic reaction to hyaluronic acid dermal fillers, hyaluronidase, or any ingredients of the aforementioned products
- •Active, uncontrolled inflammatory condition of any type
- •History of allergic reaction to lidocaine
研究组 & 干预措施
Filler
Each subject will have one product in one forearm and another product in the other. Products: JUVEDERM Ultra Plus (24 mg/mL of HA) and VOLUMA (20 mg/mL of HA). Subjects will be randomized as to which forearm will receive which product. In one forearm, subject will receive four injections of the assigned HA filler (0.2mL). HA injections will be placed along a line from the wrist to the antecubital fossa. The initial 0.2mL HA injection will be placed in the deep dermis 5 cm from the wrist and the subsequent three 0.2mL HA injections will be place in 5 cm increments in the deep dermis along the line noted above. Same process will be used on the contralateral forearm using the other HA filler.1-3 hours post injection, these 8 HA injection sites (4 per forearm) per subject will then receive a randomized amount of Hylenex recombinant (0U, 30U, 60U or 75U).
干预措施: Hylenex (Drug)
结局指标
主要结局
Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)
时间窗: 2-6 hours post initial injection
次要结局
- Photography (Volar Aspect) at Site of Injection(1-6 hours post initial injection day 1, day 2)
- 3-dimensional (3-D) ultrasound imaging(1-6 hours post initial injection day 1, day 2)
研究者
Steven Yoelin
Steve Yoelin M.D.
Steve Yoelin M.D. Medical Associates, Inc.