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NCT Number: NCT06665594

Effect of TXA on Reducing Bruising After Filler Injection

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Ahmed Afifi, MD

SUB_INVESTIGATOR

Daniel Cho, MD, PhD

CONTACT

[email protected]

608-263-7502

Daniel Y Cho, MD, PhD

PRINCIPAL_INVESTIGATOR

Ellen C Shaffrey, MD

SUB_INVESTIGATOR

Jeffrey D Larson, MD

SUB_INVESTIGATOR

Peter J Wirth, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic Acid (HA)

Procedure

Injectable gel

Tranexamic acid (TXA)

Drug

Injection of TXA

Saline (Placebo)

Drug

Injection of saline

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Intensity of bruising on TXA + HA half of face

    Time frame: Post-procedure day 1

    Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising.

  2. Intensity of bruising on saline + HA half of face

    Time frame: Post-procedure day 1

    Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising.

  3. Duration of bruising on TXA + HA half of face

    Time frame: Post-procedure day 1

    Participants will indicate on what day their bruising disappeared, or whether it is still there.

  4. Duration of bruising on saline + HA half of face

    Time frame: Post-procedure day 1

    Participants will indicate on what day their bruising disappeared, or whether it is still there.

  5. Intensity of swelling on TXA + HA half of face

    Time frame: Post-procedure days 1 and 7

    Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling.

  6. Intensity of swelling on saline + HA half of face

    Time frame: Post-procedure days 1 and 7

    Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling.

  7. Intensity of pain on TXA + HA half of face

    Time frame: Post-procedure days 1 and 7

    Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible.

  8. Intensity of pain on saline + HA half of face

    Time frame: Post-procedure days 1 and 7

    Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible.

  9. Overall satisfaction with aesthetic of TXA + HA half of face

    Time frame: Post-procedure days 1 and 7

    Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied

  10. Overall satisfaction with aesthetic of saline + HA half of face

    Time frame: Post-procedure days 1 and 7

    Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Cho, MD, PhD

CONTACT

[email protected]

608-263-6330

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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