Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment
研究概览
简要总结
The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment
详细描述
This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and older
- •No significant medical illness
- •Subjects with the willingness and ability to understand and provide informed consent
排除标准
- •Under 18 years of age
- •Pregnancy or Lactation
- •Subjects who have had previous surgical treatment of the lower eyelid area or previous use of filling agents in the under eye area
- •Subjects with a known allergy to the components in Restylane® or Perlane®
- •Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
- •Subjects with liver/kidney disease or compromise or who are immunocompromised
- •Subjects with a known susceptibility to keloid formation or hypertrophic scarring
- •Subjects with an open, non-healing sore or infection near the site of injections
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects with mental illness
研究组 & 干预措施
Restalyne and Perlane
One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
干预措施: Restalyne (Drug)
Restalyne and Perlane
One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
干预措施: Perlane (Drug)
结局指标
主要结局
The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment
时间窗: 1 year
次要结局
未报告次要终点