Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life (FACE-Q Scale)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To determine the effects of Restylane-L® Filler injection into the nose on first impressions and quality of life based on the validated questionnaires using FACE-Q scales.
研究概览
简要总结
The purpose of this research is to determine the effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life determined by using the FACE-Q Scale.
Secondary objectives include:
To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.
To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females of ages 21 and above.
- •Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
- •Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.
排除标准
- •Males and females below age of
- •Subjects who have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
- •Subjects who are pregnant or nursing.
- •Subjects with a known allergy or sensitivity to any component of the study ingredients.
- •Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
- •Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
- •Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose, implants, and previous surgical rhinoplasty.
- •Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.
研究组 & 干预措施
Experimental: Restylane-L® Filler injection
干预措施: Restylane-L® Filler injection (Drug)
结局指标
主要结局
To determine the effects of Restylane-L® Filler injection into the nose on first impressions and quality of life based on the validated questionnaires using FACE-Q scales.
时间窗: 4 weeks
We will measure changes in first impressions using a questionnaire with categories which include social skills, academic performance, dating success, occupational success, attractiveness, financial success, relationship success, and athletic skills. The 300 independent reviewers will grade each photo on a scale of 1(least favorable) to 10 (best). Evaluation of effects on quality of life will be reported through comparison of pre/post injection quality of life survey scores filled out by patients using the validated FACE-Q PRO survey measure (categories include appraisal of nasal appearance, psychological well-being, social function, and psychological distress). Maximal reported score is 4 (very satisfied) and lowest reported score is 1 (very dissatisfied).
次要结局
- To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.(4 weeks)
- To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.(4 weeks)
- To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty by recording the number of participants with treatment-related adverse events as assessed by CTCAE v4.0(4 weeks)
研究者
Steven H. Dayan
Principal Investigator, Clinical Assistant Professor
University of Illinois at Chicago