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| ID | Type | Description | Link |
|---|---|---|---|
| A539730 | Other Identifier | UW- Madison | |
| Protocol Version 3/13/26 | Other Identifier | UW- Madison |
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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:
Participants will receive the study medication along with the standard facial filler injection and complete surveys.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial Filler Injection | Experimental | TXA plus HA injection in half of face, saline plus HA injection on other half of face |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid (HA) | Procedure | Injectable gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of bruising on TXA + HA half of face | Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising. | Post-procedure day 7 |
| Intensity of bruising on saline + HA half of face | Participants will score the intensity of bruising on a 5-point Likert scale, where 1 = no bruising and 5 = severe bruising. | Post-procedure day 7 |
| Duration of bruising on TXA + HA half of face | Participants will indicate on what day their bruising disappeared, or whether it is still there. | Post-procedure day 7 |
| Duration of bruising on saline + HA half of face | Participants will indicate on what day their bruising disappeared, or whether it is still there. | Post-procedure day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of bruising on TXA + HA half of face | Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising. | Post-procedure day 1 |
| Intensity of bruising on saline + HA half of face |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armin Edalatpour, MD | Contact | 608-263-7502 | edalatpour@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Cho, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D003509 | Cyclohexanecarboxylic Acids |
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| Tranexamic Acid (TXA) |
| Drug |
Injection of TXA |
|
| Saline (placebo) | Drug | Injection of saline |
|
Participants will score the intensity of bruising on a 5-point Likert scale, where 1= no bruising and 5= severe bruising.
| Post-procedure day 1 |
| Duration of bruising on TXA + HA half of face | Participants will indicate on what day their bruising disappeared, or whether it is still there. | Post-procedure day 1 |
| Duration of bruising on saline + HA half of face | Participants will indicate on what day their bruising disappeared, or whether it is still there. | Post-procedure day 1 |
| Intensity of swelling on TXA + HA half of face | Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling. | Post-procedure days 1 and 7 |
| Intensity of swelling on saline + HA half of face | Participants will score the intensity of swelling on a 5-point Likert scale, where 1 = no swelling and 5 = severe swelling. | Post-procedure days 1 and 7 |
| Intensity of pain on TXA + HA half of face | Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible. | Post-procedure days 1 and 7 |
| Intensity of pain on saline + HA half of face | Participants will score the intensity of pain on a 10-point Likert scale, where 0 = no pain and 10 = worst pain possible. | Post-procedure days 1 and 7 |
| Overall satisfaction with aesthetic of TXA + HA half of face | Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied | Post-procedure days 1 and 7 |
| Overall satisfaction with aesthetic of saline + HA half of face | Participants will rate their overall satisfaction on a 5-point Likert scale where 1 = completely dissatisfied and 5 = completely satisfied | Post-procedure days 1 and 7 |
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |