NCT02689947已完成不适用
Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity
Nashville Centre for Laser and Facial Surgery0 个研究点目标入组 30 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Primary outcome effectiveness analysis will test for the mean difference and overall improvement of radial smile lines based on baseline assessment and changes to the 6 month visit
研究概览
简要总结
Prospective single center study to evaluate the safety and effectiveness of Restylane Silk for treatment of tear trough correction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy male or female between 21 and 65 years old
- •Tear trough deformity, Hirmand Type-1 and Type-2
- •Is voluntarily willing to consent to participate in the study
- •Is willing to comply with all requirements of the study including being photographed, follow post treatment care instructions, to attend all treatment, and follow up visits
- •Willingness to waive rights to use of still photos of themselves for research, marketing, or promotional reasons, including on the internet and on social media outlets.
- •Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study.
- •Ability to provide informed consent.
排除标准
- •Marked delineation of the inferior orbital rim in the lateral aspect of the eyelid/orbit
- •Use of botulinum toxin in the periorbital region within the past 6 months.
- •Treatment with injectable fillers in the midface or periorbital region within the past 2 years or treatment at any time in the past with a permanent filler in the midface or periorbital region such as silicone, or PMMA (Artefill)
- •Laser skin resurfacing of the periorbital region within the past one year.
- •History of lower eyelid blepharoplasty or periorbital surgery in tear trough region.
- •The subject has a coagulation disorder or is currently using anti-coagulation medication
- •History of facial nerve palsy.
- •Inability to discontinue the use of nonsteroidal anti-inflammatory drugs or anticoagulants prior to treatment.
- •Current participation in another active clinical trial protocol
- •Presence of malar festoons
- •Active cutaneous infections
- •Allergy or sensitivity to benzocaine, lidocaine, prilocaine, or tetracaine.
- •Pregnant or nursing females
- •Other factors as deemed by the Principal Investigator that would make a subject unqualified for participation.
- •The subject has a history of keloids or compromised wound healing
- •The subject has a known adverse reaction to previous injection with hyaluronic acid or other subcutaneously injected device
结局指标
主要结局
Primary outcome effectiveness analysis will test for the mean difference and overall improvement of radial smile lines based on baseline assessment and changes to the 6 month visit
时间窗: baseline to month 6
Primary outcome effectiveness analysis will test for the mean difference in improvement in terms of baseline to Month 6
次要结局
未报告次要终点
研究者
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