Effect of TXA on Reducing Bruising After Filler Injection

NCT06665594 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2024-1103A539730Protocol Version 8/13/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Filler Injections; Hyaluronic Acid; Tranexamic Acid

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Study Arms (1)

Facial Filler Injection

EXPERIMENTAL

TXA plus HA injection in half of face, saline plus HA injection on other half of face

Procedure: Hyaluronic Acid (HA); Drug: Tranexamic Acid (TXA); Drug: Saline (placebo)

Interventions

Hyaluronic Acid (HA) PROCEDURE

Injectable gel

Facial Filler Injection

Tranexamic Acid (TXA) DRUG

Injection of TXA

Facial Filler Injection

Saline (placebo) DRUG

Injection of saline

Facial Filler Injection

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or greater than 18 but less than or equal to 89 years.
• Participants interested in facial filler (HA) injection.
• English speaking.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Interventions

Hyaluronic Acid; Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daniel Cho, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armin Edalatpour, MD

CONTACT

608-263-7502; edalatpour@wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: December 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)