Effect of TXA on Reducing Bruising After Filler Injection

NCT ID: NCT06665594

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-05

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Facial Filler Injections Hyaluronic Acid Tranexamic Acid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Facial Filler Injection

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

Group Type EXPERIMENTAL

Hyaluronic Acid (HA)

Intervention Type PROCEDURE

Injectable gel

Tranexamic Acid (TXA)

Intervention Type DRUG

Injection of TXA

Saline (placebo)

Intervention Type DRUG

Injection of saline

Interventions

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Hyaluronic Acid (HA)

Injectable gel

Intervention Type PROCEDURE

Tranexamic Acid (TXA)

Injection of TXA

Intervention Type DRUG

Saline (placebo)

Injection of saline

Intervention Type DRUG

Eligibility Criteria

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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 hemodialysis or peritoneal dialysis
* History of diabetes or seizures
* Current tobacco smokers
* Acquired defective color vision
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Armin Edalatpour, MD

Role: CONTACT

608-263-7502

Facility Contacts

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Armin Edalatpour, MD

Role: primary

608-263-7502

Other Identifiers

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A539730

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/13/25

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1103

Identifier Type: -

Identifier Source: org_study_id

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