Use of Tranexamic Acid in Facial Fillers
- Conditions
- Injection Site Bruising
- Interventions
- Registration Number
- NCT04373603
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control: HA plus Saline Saline HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline Intervention: HA plus TXA Tranexamic acid 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) Intervention: HA plus TXA Hyaluronic acid 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) Control: HA plus Saline Hyaluronic acid HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline
- Primary Outcome Measures
Name Time Method Intensity of Bruising Score Post procedure day 7 Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.
- Secondary Outcome Measures
Name Time Method Intensity of Swelling Score Post procedure day 30 Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.
Intensity of Bruising Score Post procedure day 30 Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.
Participant Satisfaction Score Post procedure day 30 Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
Pain Score Post procedure day 30 Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
Trial Locations
- Locations (1)
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States