Effect of TXA on Reducing Bruising After Filler Injection

University of Wisconsin (UW)

Status and phase: Not yet enrolling; Phase 2

Conditions: Tranexamic Acid; Hyaluronic Acid; Facial Filler Injections

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06665594

A539730 (Other Identifier)

Protocol Version 3/9/24 (Other Identifier)

2024-1103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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
• Concurrent use of estrogen
• 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 hemo- or peritoneal dialysis
• History of diabetes or seizures
• Current tobacco smokers
• Acquired defective color vision

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Facial Filler Injection

Experimental group

Description:

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

Treatment:

Drug: Saline (placebo)

Drug: Tranexamic Acid (TXA)

Procedure: Hyaluronic Acid (HA)