Effect of TXA on Reducing Bruising After Filler Injection

Phase 2RecruitingNCT06665594

University of Wisconsin, Madison40 enrolled

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Facial Filler Injections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Post-procedure day 7

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.