Does TXA Reduce Bruising After Hyaluronic Acid Filler Injection? A Prospective Half Face Study
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Intensity of bruising on TXA + HA half of face
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age equal to or greater than 18 but less than or equal to 89 years.
- •Participants interested in facial filler (HA) injection.
- •English speaking.
Exclusion Criteria
- •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
- •Concurrent use of estrogen
- •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
Arms & Interventions
Facial Filler Injection
TXA plus HA injection in half of face, saline plus HA injection on other half of face
Intervention: Hyaluronic Acid (HA) (Procedure)
Facial Filler Injection
TXA plus HA injection in half of face, saline plus HA injection on other half of face
Intervention: Tranexamic Acid (TXA) (Drug)
Facial Filler Injection
TXA plus HA injection in half of face, saline plus HA injection on other half of face
Intervention: Saline (placebo) (Drug)
Outcomes
Primary Outcomes
Intensity of bruising on TXA + HA half of face
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Post-procedure day 7
Participants will indicate on what day their bruising disappeared, or whether it is still there.
Secondary Outcomes
- 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)