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NCT06665594 | NOT YET RECRUITING | Facial Filler Injections

Effect of TXA on Reducing Bruising After Filler Injection
Sponsor:

University of Wisconsin, Madison

Brief Summary:

The goal of this clinical trial is to look at the effect tranexamic acid (TXA) may have on reducing bruising, swelling, and pain after facial filler injection. The main question it aims to answer is: * Does the addition of TXA to hyaluronic acid (HA) reduce bruising, swelling, and tenderness after HA injection? Participants will receive the study medication along with the standard facial filler injection and complete surveys.

Condition or disease

Facial Filler Injections

Hyaluronic Acid

Tranexamic Acid

Intervention/treatment

Hyaluronic Acid (HA)

Tranexamic Acid (TXA)

Saline (placebo)

Phase

PHASE2

Detailed Description:

The overall purpose of this study is to evaluate the safety and efficacy of co-administration of TXA with HA in reducing swelling, bruising and pain after facial injection. Researchers will do this by comparing HA to HA+TXA in participants undergoing facial filler injections. Participants 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. Therefore, researchers have designed this as a half face study. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Researchers will then assess swelling, bruising, pain, and overall satisfaction using participant self-reported surveys, physician surveys, and review of medical records.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Does TXA Reduce Bruising After Hyaluronic Acid Filler Injection? a Prospective Half Face Study
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Age equal to or greater than 18 but less than or equal to 89 years.
  • * Participants interested in facial filler (HA) injection.
  • * English speaking.
Exclusion Criteria
  • * Minors or under the age of 18
  • * Participant 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.
  • * Individuals with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis
  • * Concurrent use of estrogen
  • * Participants undergoing unilateral facial filler (HA) injection
  • * Participants with history of hypersensitivity to TXA or any of the other ingredients
  • * Participants that are on current therapeutic anticoagulation therapy and aspirin use
  • * Participants with stage 2 or greater renal failure
  • * Participants on hemo- or peritoneal dialysis
  • * History of diabetes or seizures
  • * Current tobacco smokers
  • * Acquired defective color vision
Effect of TXA on Reducing Bruising After Filler Injection

Location Details

NCT06665594

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Wisconsin

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53705