WithdrawnPhase 4

Use of Tranexamic Acid in Facial Fillers

Stopped: Study closed prior to opening to enrollment, due to funding availability for study

United States0Started 2022-07

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Intensity of Bruising Score

Timeframe: Post procedure day 7

Trial details

NCT IDNCT04373603

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07