Use of Tranexamic Acid in Facial Fillers

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler

Conditions
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Injection Site Bruising

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: Saline
* Drug: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: half face study where participant serves as own control, intervention on one side of the face, control on the other
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: HA plus TXA<br>HA will be diluted with TXA using a Leur-Lok hub in a ratio of 1.0 mL HA filler to 0.2 mL TXA (100mg/mL) | Drug: Tranexamic acid<br>* 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<br>* Other names: TXA;Drug: Hyaluronic acid<br>* 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<br>* Other names: Hyaluronidase;|
| Placebo Comparator: Control: HA plus Saline<br>HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline | Other: Saline<br>* sodium chloride and water for use as control<br>Drug: Hyaluronic acid<br>* 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<br>* Other names: Hyaluronidase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post procedure day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Post procedure day 1 | 
| Pain Score | Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain. | Post procedure day 7 | 
| Pain Score | Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain. | Post procedure day 30 | 
| Participant Satisfaction Score | Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied. | Post procedure day 1 | 
| Participant Satisfaction Score | Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied. | Post procedure day 7 | 
| Participant Satisfaction Score | Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied. | Post procedure day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient satisfaction, plastic surgery