Effect of TXA on Reducing Bruising After Filler Injection

Does TXA Reduce Bruising After Hyaluronic Acid Filler Injection? A Prospective Half Face Study

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.

Study Overview

• Status: Recruiting
• Conditions: Tranexamic Acid; Hyaluronic Acid; Facial Filler Injections
• Intervention / Treatment: Procedure: Hyaluronic Acid (HA); Drug: Tranexamic Acid (TXA); Drug: Saline (placebo)

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Armin Edalatpour, MD; Phone Number: 608-263-7502; Email: edalatpour@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin - Madison
      • Contact: Armin Edalatpour, MD; Phone Number: 608-263-7502; Email: edalatpour@wisc.edu
      • Principal Investigator: Daniel Y Cho, MD, PhD
      • Sub-Investigator: Ahmed Afifi, MD
      • Sub-Investigator: Jeffrey D Larson, MD
      • Sub-Investigator: Armin Edalatpour, MD
      • Sub-Investigator: Ellen C Shaffrey, MD
      • Sub-Investigator: Peter J Wirth, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of bruising on TXA + HA half of face	Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising.	Post-procedure day 7
Intensity of bruising on saline + HA half of face	Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising.	Post-procedure day 7
Duration of bruising on TXA + HA half of face	Participants will indicate on what day their bruising disappeared, or whether it is still there.	Post-procedure day 7
Duration of bruising on saline + HA half of face	Participants will indicate on what day their bruising disappeared, or whether it is still there.	Post-procedure day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of bruising on TXA + HA half of face	Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising.	Post-procedure day 1
Intensity of bruising on saline + HA half of face	Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising.	Post-procedure day 1
Duration of bruising on TXA + HA half of face	Participants will indicate on what day their bruising disappeared, or whether it is still there.	Post-procedure day 1
Duration of bruising on saline + HA half of face	Participants will indicate on what day their bruising disappeared, or whether it is still there.	Post-procedure day 1
Intensity of swelling on TXA + HA half of face	Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling.	Post-procedure days 1 and 7
Intensity of swelling on saline + HA half of face	Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling.	Post-procedure days 1 and 7
Intensity of pain on TXA + HA half of face	Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible.	Post-procedure days 1 and 7
Intensity of pain on saline + HA half of face	Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible.	Post-procedure days 1 and 7
Overall satisfaction with aesthetic of TXA + HA half of face	Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied	Post-procedure days 1 and 7
Overall satisfaction with aesthetic of saline + HA half of face	Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied	Post-procedure days 1 and 7

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Daniel Cho, MD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating; Contusions; Organic Chemicals; Carbohydrates; Carboxylic Acids; Inorganic Chemicals; Chlorine Compounds; Glycosaminoglycans; Polysaccharides; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Sodium Compounds; Chlorides; Hydrochloric Acid; Tranexamic Acid; Hyaluronic Acid; Sodium Chloride
• Other Study ID Numbers: 2024-1103; A539730 (Other Identifier: UW- Madison); Protocol Version 3/13/26 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No