Does TXA Reduce Bruising After Hyaluronic Acid Filler Injection? A Prospective Half Face Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intensity of bruising on TXA + HA half of face
研究概览
简要总结
The goal of this clinical trial is to look at the effect tranexamic acid (TXA) may have on reducing bruising, swelling, and pain after facial filler injection. The main question it aims to answer is:
- Does the addition of TXA to hyaluronic acid (HA) reduce bruising, swelling, and tenderness after HA injection?
Participants will receive the study medication along with the standard facial filler injection and complete surveys.
详细描述
The overall purpose of this study is to evaluate the safety and efficacy of co-administration of TXA with HA in reducing swelling, bruising and pain after facial injection. Researchers will do this by comparing HA to HA+TXA in participants undergoing facial filler injections. Participants 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. Therefore, researchers have designed this as a half face study. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Researchers will then assess swelling, bruising, pain, and overall satisfaction 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
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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.
- •Participants interested in facial filler (HA) injection.
- •English speaking.
排除标准
- •Minors or under the age of 18
- •Participant 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.
- •Individuals with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis
- •Participants undergoing unilateral facial filler (HA) injection
- •Participants with history of hypersensitivity to TXA or any of the other ingredients
- •Participants that are on current therapeutic anticoagulation therapy and aspirin use
- •Participants with stage 2 or greater renal failure
- •Participants on hemodialysis or peritoneal dialysis
- •History of diabetes or seizures
- •Current tobacco smokers
- •Acquired defective color vision
研究组 & 干预措施
Facial Filler Injection
TXA plus HA injection in half of face, saline plus HA injection on other half of face
干预措施: Tranexamic Acid (TXA) (Drug)
Facial Filler Injection
TXA plus HA injection in half of face, saline plus HA injection on other half of face
干预措施: Hyaluronic Acid (HA) (Procedure)
Facial Filler Injection
TXA plus HA injection in half of face, saline plus HA injection on other half of face
干预措施: Saline (placebo) (Drug)
结局指标
主要结局
Intensity of bruising on TXA + HA half of face
时间窗: Post-procedure day 7
Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising.
Intensity of bruising on saline + HA half of face
时间窗: Post-procedure day 7
Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising.
Duration of bruising on TXA + HA half of face
时间窗: Post-procedure day 7
Participants will indicate on what day their bruising disappeared, or whether it is still there.
Duration of bruising on saline + HA half of face
时间窗: Post-procedure day 7
Participants will indicate on what day their bruising disappeared, or whether it is still there.
次要结局
- Intensity of bruising on TXA + HA half of face(Post-procedure day 1)
- Intensity of bruising on saline + HA half of face(Post-procedure day 1)
- Duration of bruising on TXA + HA half of face(Post-procedure day 1)
- Duration of bruising on saline + HA half of face(Post-procedure day 1)
- Intensity of swelling on TXA + HA half of face(Post-procedure days 1 and 7)
- Intensity of swelling on saline + HA half of face(Post-procedure days 1 and 7)
- Intensity of pain on TXA + HA half of face(Post-procedure days 1 and 7)
- Intensity of pain on saline + HA half of face(Post-procedure days 1 and 7)
- Overall satisfaction with aesthetic of TXA + HA half of face(Post-procedure days 1 and 7)
- Overall satisfaction with aesthetic of saline + HA half of face(Post-procedure days 1 and 7)