Clinical trial NCT06665594: Effect of TXA on Reducing Bruising After Filler Injection
Official title: Does TXA Reduce Bruising After Hyaluronic Acid Filler Injection? A Prospective Half Face Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Facial Filler Injections
Hyaluronic Acid
Tranexamic Acid
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Intensity of bruising on TXA + HA half of face
timeFrame: Post-procedure day 7
measure: Intensity of bruising on saline + HA half of face
timeFrame: Post-procedure day 7
measure: Duration of bruising on TXA + HA half of face
timeFrame: Post-procedure day 7
measure: Duration of bruising on saline + HA half of face
timeFrame: Post-procedure day 7
Secondary outcomes:
measure: Intensity of bruising on TXA + HA half of face
timeFrame: Post-procedure days 1 and 14
measure: Intensity of bruising on saline + HA half of face
timeFrame: Post-procedure days 1 and 14
measure: Duration of bruising on TXA + HA half of face
timeFrame: Post-procedure day 14
measure: Duration of bruising on saline + HA half of face
timeFrame: Post-procedure day 14
measure: Intensity of swelling on TXA + HA half of face
timeFrame: Post-procedure days 1, 7, and 14
measure: Intensity of swelling on saline + HA half of face
timeFrame: Post-procedure days 1, 7, and 14
measure: Intensity of pain on TXA + HA half of face
timeFrame: Post-procedure days 1, 7, and 14
measure: Intensity of pain on saline + HA half of face
timeFrame: Post-procedure days 1, 7, and 14
measure: Overall satisfaction with aesthetic of TXA + HA half of face
timeFrame: Post-procedure days 1, 7, and 14
measure: Overall satisfaction with aesthetic of saline + HA half of face
timeFrame: Post-procedure days 1, 7, and 14
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Daniel Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: