Effect of TXA on Reducing Bruising After Filler Injection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age equal to or greater than 18 but less than or equal to 89 years.
Participants interested in facial filler (HA) injection.
English speaking.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Hyaluronic Acid (HA)
Procedure/SurgeryInjectable gel
Tranexamic Acid (TXA)
DrugInjection of TXA
Saline (placebo)
DrugInjection of saline
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Facial Filler InjectionExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-procedure day 72
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.
Time frame
Post-procedure day 73
Duration of bruising on TXA + HA half of face
Participants will indicate on what day their bruising disappeared, or whether it is still there.
Time frame
Post-procedure day 74
Duration of bruising on saline + HA half of face
Participants will indicate on what day their bruising disappeared, or whether it is still there.
Time frame
Post-procedure day 7Secondary outcomes
1
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.
Time frame
Post-procedure day 12
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.
Time frame
Post-procedure day 13
Duration of bruising on TXA + HA half of face
Participants will indicate on what day their bruising disappeared, or whether it is still there.
Time frame
Post-procedure day 14
Duration of bruising on saline + HA half of face
Participants will indicate on what day their bruising disappeared, or whether it is still there.
Time frame
Post-procedure day 1Sponsors and contacts
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Source ClinicalTrials.gov