NCT04769427已完成不适用
Non-Surgical Rhinoplasty Using Polydioxanone Threads
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Non -surgical rhinoplasty using PDO Max threads
研究概览
简要总结
To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical revision rhinoplasty on first impressions and quality of life (FACE-Q scale) in 10 patients who desire further changes to their nasal tip and/or nasal dorsum
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Males and females of ages 18 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 surgery, filler injections, or other cosmetic treatments to the nose within the last 12 months.
- •Patients with any prior nasal implants
- •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
- •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.
结局指标
主要结局
Non -surgical rhinoplasty using PDO Max threads
时间窗: 1 month
The effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale). FACE-Q scales are rated from 1-4 with ratings closer to 4 as more favorable.
次要结局
- Non -surgical rhinoplasty using PDO Max threads(1 month)
研究者
研究点 (2)
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