Use of Tranexamic Acid in Facial Fillers

University of Wisconsin (UW)

Status and phase: Withdrawn; Phase 4

Conditions: Injection Site Bruising

Treatments: Drug: Tranexamic acid; Other: Saline; Drug: Hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04373603

Protocol version 0.11 (Other Identifier)

A539730 (Other Identifier)

2020-0573

SMPH/SURGERY/DENTL-PLASTC SRGY (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

Intervention: HA plus TXA

Experimental group

Description:

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)

Treatment:

Drug: Hyaluronic acid

Drug: Tranexamic acid

Control: HA plus Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Hyaluronic acid

Other: Saline