NCT04373603

Use of Tranexamic Acid in Facial Fillers

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2020-05-04
• Last updated: 2022-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study