ClinicalTrials.gg
WithdrawnNCT04373603Updated Jul 26, 2022

Use of Tranexamic Acid in Facial Fillers

A Phase 4 interventional study of Tranexamic acid and Saline in Injection Site Bruising, sponsored by University of Wisconsin, Madison. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Supportive care

Why this study was withdrawn
Study closed prior to opening to enrollment, due to funding availability for study
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 198 studies in Patient Satisfaction with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Patient Satisfaction · United States.

Enrollment
152nd of 162
0 · median 100
Started
2022
with 14 others
Phase 4
18 of 198
2 open now
Registered
108th of 198
by date

Among the 198 studies in Patient Satisfaction with a site in United States, this one is the 152nd largest by enrollment of the 162 interventional ones that give a count, is one of 15 that started in 2022, is one of 18 in phase 4, and was the 108th registered.

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

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Open to participants now

30 of the 198 studies in Patient Satisfaction with a site in United States are open now. Recruiting first, the newest first:

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All 30 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 99 Patient Satisfaction studies recruiting now, 61 (62%) set no upper age limit and 30 (30%) stop at 75 or younger; 14 take children under 18; 26 take healthy volunteers.

This study: 18 Years to 89 Years · all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Injection Site Bruising

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Keywords

  • patient satisfaction
  • plastic surgery
04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention: HA plus TXA

    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)

    Drug: Tranexamic acid · Drug: Hyaluronic acid

  • Placebo comparator
    Control: HA plus Saline

    HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline

    Other: Saline · Drug: Hyaluronic acid

Interventions

  • TXA is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, thus inhibiting degradation of fibrin clots and serving as an antifibrinolytic

    Also known as: TXA

  • OtherSaline

    sodium chloride and water for use as control

  • Hyaluronidase is a spreading or diffusing substance which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue

    Also known as: HA, Hyaluronidase

06

What researchers measure

Primary outcomes

  1. Intensity of Bruising Score

    Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.

    Time frame: Post procedure day 7

Secondary outcomes

  1. Intensity of Bruising Score

    Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.

    Time frame: Post procedure day 1

  2. Intensity of Bruising Score

    Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.

    Time frame: Post procedure day 30

  3. Intensity of Swelling Score

    Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.

    Time frame: Post procedure day 1

  4. Intensity of Swelling Score

    Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.

    Time frame: Post procedure day 7

  5. Intensity of Swelling Score

    Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.

    Time frame: Post procedure day 30

  6. Pain Score

    Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.

    Time frame: Post procedure day 1

  7. Pain Score

    Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.

    Time frame: Post procedure day 7

  8. Pain Score

    Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.

    Time frame: Post procedure day 30

  9. Participant Satisfaction Score

    Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.

    Time frame: Post procedure day 1

  10. Participant Satisfaction Score

    Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.

    Time frame: Post procedure day 7

  11. Participant Satisfaction Score

    Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.

    Time frame: Post procedure day 30

07

Study locations

1 site
  • University of Wisconsin School of Medicine and Public Health
    Madison, Wisconsin 53792, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2022; primary completion for Jul 2023, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2020
First posted
May 4, 2020
StartEst.
Jul 2022
Primary completionEst.
Jul 2023
CompletionEst.
Jul 2023
Last update
Jul 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04373603
Responsible party
Sponsor
First posted
May 4, 2020
Start date
Jul 2022 (estimated)
Primary completion
Jul 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Jul 26, 2022

Study contacts

Ahmed M Afifi, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tranexamic Acid

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