Effect of TXA on Reducing Bruising After Filler Injection

Purpose

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.

Conditions

  • Facial Filler Injections
  • Hyaluronic Acid
  • Tranexamic Acid

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible 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 - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Facial Filler Injection
TXA plus HA injection in half of face, saline plus HA injection on other half of face
  • Procedure: Hyaluronic Acid (HA)
    Injectable gel
  • Drug: Tranexamic Acid (TXA)
    Injection of TXA
  • Drug: Saline (placebo)
    Injection of saline

Recruiting Locations

University of Wisconsin - Madison
Madison, Wisconsin 53705
Contact:
Daniel Cho, MD, PhD
608-263-7502
chod@surgery.wisc.edu

More Details

Status
Recruiting
Sponsor
University of Wisconsin, Madison

Study Contact

Daniel Cho, MD, PhD
608-263-6330
chod@surgery.wisc.edu

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.