Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Intensity of Bruising Score
研究概览
简要总结
The overall purpose of this study is to evaluate the safety and efficacy of co-administration of tranexamic acid (TXA) with hyaluronic acid (HA) in reducing swelling, bruising and pain after facial injection. This will be done by comparing HA to HA+TXA in participants undergoing facial filler injections. Patients undergoing facial filler injections almost always have the same type of injection performed bilaterally in order to maintain symmetry. This provides a unique opportunity where participants can serve as their own controls. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Swelling, bruising, pain, and overall satisfaction will be assessed using participant self-reported surveys, physician surveys, and review of medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
side of face for treatment is randomized and double blinded to the participant and physician
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age equal to or greater than 18 but less than or equal to 89 years.
- •Medically appropriate to undergo elective facial filler injection at UW Health by principal investigator
- •English speaking
排除标准
- •Minors or under the age of 18
- •Patient over the age of 89
- •Pregnant or breast-feeding women
- •Individuals unable to give consent due to another condition such as impaired decision-making capacity.
- •Participants with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis
- •Concurrent use of estrogen
- •Participant undergoing unilateral facial filler injections
- •Participants with history of hypersensitivity to TXA or any of the other ingredients
- •Participants that are on current therapeutic anticoagulation therapy
- •Participants with stage 2 or greater renal failure
- •Participants on hemo- or peritoneal dialysis
研究组 & 干预措施
Intervention: HA plus TXA
HA will be diluted with TXA using a Leur-Lok hub in a ratio of 1.0 mL HA filler to 0.2 mL TXA (100mg/mL)
干预措施: Tranexamic acid (Drug)
Intervention: HA plus TXA
HA will be diluted with TXA using a Leur-Lok hub in a ratio of 1.0 mL HA filler to 0.2 mL TXA (100mg/mL)
干预措施: Hyaluronic acid (Drug)
Control: HA plus Saline
HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline
干预措施: Saline (Other)
Control: HA plus Saline
HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
Intensity of Bruising Score
时间窗: Post procedure day 7
Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.
次要结局
- Intensity of Swelling Score(Post procedure day 30)
- Intensity of Bruising Score(Post procedure day 30)
- Participant Satisfaction Score(Post procedure day 30)
- Pain Score(Post procedure day 30)