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Recruiting NCT06665594

Effect of TXA on Reducing Bruising After Filler Injection

Phase II Interventional Facial Filler Injections Hyaluronic Acid Tranexamic Acid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyaluronic Acid (HA), Tranexamic Acid (TXA), Saline (placebo).
Who it may be relevant to
Registry conditions: Facial Filler Injections, Hyaluronic Acid, Tranexamic Acid. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Hyaluronic Acid (HA)
    Injectable gel
  • Drug Tranexamic Acid (TXA)
    Injection of TXA
  • Drug Saline (placebo)
    Injection of saline

Primary outcome measures

  • Intensity of bruising on TXA + HA half of face [Time frame: Post-procedure day 7]
  • Intensity of bruising on saline + HA half of face [Time frame: Post-procedure day 7]
  • Duration of bruising on TXA + HA half of face [Time frame: Post-procedure day 7]
  • Duration of bruising on saline + HA half of face [Time frame: Post-procedure day 7]
Secondary outcome measures (10)
  • Intensity of bruising on TXA + HA half of face [Time frame: Post-procedure day 1]
  • Intensity of bruising on saline + HA half of face [Time frame: Post-procedure day 1]
  • Duration of bruising on TXA + HA half of face [Time frame: Post-procedure day 1]
  • Duration of bruising on saline + HA half of face [Time frame: Post-procedure day 1]
  • Intensity of swelling on TXA + HA half of face [Time frame: Post-procedure days 1 and 7]
  • Intensity of swelling on saline + HA half of face [Time frame: Post-procedure days 1 and 7]
  • Intensity of pain on TXA + HA half of face [Time frame: Post-procedure days 1 and 7]
  • Intensity of pain on saline + HA half of face [Time frame: Post-procedure days 1 and 7]
  • Overall satisfaction with aesthetic of TXA + HA half of face [Time frame: Post-procedure days 1 and 7]
  • Overall satisfaction with aesthetic of saline + HA half of face [Time frame: Post-procedure days 1 and 7]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Wisconsin - Madison — Madison

Identifiers

NCT: NCT06665594 · 2024-1103 · A539730 · Protocol Version 3/13/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗