Use of Tranexamic Acid in Facial Fillers

Injection Site Bruising Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04373603
• Other study ID #: 2020-0573
• Secondary ID: A539730SMPH/SURG
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2022
• Est. completion date: July 2023

Study information

• Verified date: July 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Contusions
• Injection Site Bruising

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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