Facial Filler Injections, Hyaluronic Acid, Tranexamic Acid
Conditions
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.
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.
Interventions
PROCEDUREHyaluronic Acid (HA)
Injectable gel
DRUGTranexamic Acid (TXA)
Injection of TXA
DRUGSaline (placebo)
Injection of saline
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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 * 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 hemodialysis or peritoneal dialysis * History of diabetes or seizures * Current tobacco smokers * Acquired defective color vision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of bruising on TXA + HA half of face | Post-procedure day 7 | Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising. |
| Intensity of bruising on saline + HA half of face | Post-procedure day 7 | Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising. |
| Duration of bruising on TXA + HA half of face | Post-procedure day 7 | Participants will indicate on what day their bruising disappeared, or whether it is still there. |
| Duration of bruising on saline + HA half of face | Post-procedure day 7 | Participants will indicate on what day their bruising disappeared, or whether it is still there. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of bruising on TXA + HA half of face | Post-procedure day 1 | Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising. |
| Intensity of bruising on saline + HA half of face | Post-procedure day 1 | Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising. |
| Duration of bruising on TXA + HA half of face | Post-procedure day 1 | Participants will indicate on what day their bruising disappeared, or whether it is still there. |
| Duration of bruising on saline + HA half of face | Post-procedure day 1 | Participants will indicate on what day their bruising disappeared, or whether it is still there. |
| Intensity of swelling on TXA + HA half of face | Post-procedure days 1 and 7 | Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling. |
| Intensity of swelling on saline + HA half of face | Post-procedure days 1 and 7 | Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling. |
| Intensity of pain on TXA + HA half of face | Post-procedure days 1 and 7 | Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible. |
| Intensity of pain on saline + HA half of face | Post-procedure days 1 and 7 | Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible. |
| Overall satisfaction with aesthetic of TXA + HA half of face | Post-procedure days 1 and 7 | Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied |
| Overall satisfaction with aesthetic of saline + HA half of face | Post-procedure days 1 and 7 | Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied |
Countries
United States
Contacts
CONTACTDaniel Cho, MD, PhD
PRINCIPAL_INVESTIGATORDaniel Cho, MD, PhD
University of Wisconsin, Madison
Outcome results
None listed