Use of Tranexamic Acid in Facial Fillers

University of Wisconsin, Madison

Overview

The overall purpose of this study is to evaluate the safety and efficacy of co-administration of tranexamic acid (TXA) with hyaluronic acid (HA) in reducing swelling, bruising and pain after facial injection. This will be done by comparing HA to HA+TXA in participants undergoing facial filler injections. Patients 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. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Swelling, bruising, pain, and overall satisfaction will be assessed using participant self-reported surveys, physician surveys, and review of medical records.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Injection Site Bruising

Interventions

Tranexamic acidDRUG

TXA is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, thus inhibiting degradation of fibrin clots and serving as an antifibrinolytic

SalineOTHER

sodium chloride and water for use as control

Hyaluronic acidDRUG

Hyaluronidase is a spreading or diffusing substance which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue

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. * Medically appropriate to undergo elective facial filler injection at UW Health by principal investigator * English speaking Exclusion Criteria: * Minors or under the age of 18 * Patient 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. * Participants with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis * Concurrent use of estrogen * Participant undergoing unilateral facial filler injections * Participants with history of hypersensitivity to TXA or any of the other ingredients * Participants that are on current therapeutic anticoagulation therapy * Participants with stage 2 or greater renal failure * Participants on hemo- or peritoneal dialysis

Locations (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Intensity of Bruising Score

Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.

Time frame: Post procedure day 7

Secondary Outcomes

Intensity of Bruising Score

Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.

Time frame: Post procedure day 1

Intensity of Bruising Score

Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.

Time frame: Post procedure day 30

Intensity of Swelling Score

Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.

Time frame: Post procedure day 1

Intensity of Swelling Score

Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.

Time frame: Post procedure day 7

Intensity of Swelling Score

Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.

Time frame: Post procedure day 30

Pain Score

Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.

Time frame: Post procedure day 1

Data from ClinicalTrials.gov

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