Use of Tranexamic Acid in Facial Fillers

NCT04373603 | Withdrawn Phase 4 DMC FDA Drug

• 4 other identifiers: 2020-0573A539730SMPH/SURGERY/DENTL-PLASTC SRGYProtocol version 0.11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection Site Bruising

Keywords

patient satisfaction; plastic surgery

Outcome Measures

Primary Outcomes (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 7

Secondary Outcomes (11)

• Intensity of Bruising Score

  Post procedure day 1

• Intensity of Bruising Score

  Post procedure day 30

• Intensity of Swelling Score

  Post procedure day 1

• Intensity of Swelling Score

  Post procedure day 7

• Intensity of Swelling Score

  Post procedure day 30

Study Arms (2)

Intervention: HA plus TXA

EXPERIMENTAL

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; Drug: Hyaluronic acid

Control: HA plus Saline

PLACEBO COMPARATOR

HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline

Other: Saline; Drug: Hyaluronic acid

Interventions

Tranexamic acid DRUG

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

Also known as: TXA

Intervention: HA plus TXA

Saline OTHER

sodium chloride and water for use as control

Control: HA plus Saline

Hyaluronic acid DRUG

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

Also known as: HA, Hyaluronidase

Control: HA plus Saline; Intervention: HA plus TXA

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Tranexamic Acid; Sodium Chloride; Hyaluronic Acid; Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Officials

• Ahmed M Afifi, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: side of face for treatment is randomized and double blinded to the participant and physician
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: half face study where participant serves as own control, intervention on one side of the face, control on the other

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 4, 2020
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)