Use of Tranexamic Acid in Facial Fillers

NCT ID: NCT04373603

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: 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

Hyaluronic acid

Intervention Type: 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

Control: HA plus Saline

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

sodium chloride and water for use as control

Hyaluronic acid

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Saline

sodium chloride and water for use as control

Intervention Type: OTHER

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

Intervention Type: DRUG

Other Intervention Names

TXA; HA; Hyaluronidase

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Afifi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

A539730

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/SURGERY/DENTL-PLASTC SRGY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol version 0.11

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0573

Identifier Type: -

Identifier Source: org_study_id