Use of Tranexamic Acid in Facial Fillers

• ClinicalTrials.gov Identifier: NCT04373603
• Recruitment Status: Withdrawn
• First Posted: May 4, 2020
• Last Update Posted: July 26, 2022
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Injection Site Bruising	Drug: Tranexamic acid; Other: Saline; Drug: Hyaluronic acid	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: half face study where participant serves as own control, intervention on one side of the face, control on the other
• Masking: Double (Participant, Investigator)
• Masking Description: side of face for treatment is randomized and double blinded to the participant and physician
• Primary Purpose: Supportive Care
• Official Title: Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler
• Estimated Study Start Date: July 2022
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

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 Name: 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	Other: Saline; sodium chloride and water for use as control; 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

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

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT04373603
• 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 )
• First Posted: May 4, 2020
• Last Update Posted: July 26, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by University of Wisconsin, Madison:

patient satisfaction; plastic surgery

Additional relevant MeSH terms:

Contusions; Wounds, Nonpenetrating; Wounds and Injuries; Tranexamic Acid; Hyaluronic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents