Use of Tranexamic Acid in Facial Fillers

July 21, 2022 updated by: University of Wisconsin, Madison

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: HA plus TXA
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
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
Other Names:
  • TXA
Drug: Hyaluronic acid
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
Other Names:
  • HA
  • Hyaluronidase
Placebo Comparator: Control: HA plus Saline
HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline
Drug: Hyaluronic acid
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
Other Names:
  • HA
  • Hyaluronidase
Other: Saline
sodium chloride and water for use as control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of Bruising Score
Time Frame: Post procedure day 7
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
Time Frame: Post procedure day 1
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
Time Frame: Post procedure day 30
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
Time Frame: Post procedure day 1
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
Time Frame: Post procedure day 7
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
Time Frame: Post procedure day 30
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
Time Frame: Post procedure day 1
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
Time Frame: Post procedure day 7
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
Time Frame: Post procedure day 30
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
Time Frame: Post procedure day 1
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
Time Frame: Post procedure day 7
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
Time Frame: Post procedure day 30
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Ahmed M Afifi, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0573
  • A539730 (Other Identifier: UW Madison)
  • SMPH/SURGERY/DENTL-PLASTC SRGY (Other Identifier: UW Madison)
  • Protocol version 0.11 (Other Identifier: HS-IRB UW, Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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