Tranexamic Acid for Reducing Bruising After Dermal Filler

Overseen By Armin Edalatpour, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Estrogen, Anticoagulants, Aspirin

Disqualifiers: Thrombosis, Renal failure, Diabetes, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

40 Participants Needed

Trial Summary

How does the drug Tranexamic Acid differ from other treatments for reducing bruising after dermal filler?

Tranexamic Acid is unique because it works by helping blood to clot, which can reduce bruising, while other treatments like lasers or hyaluronidase focus on resolving existing bruises or complications. This makes Tranexamic Acid potentially useful for preventing bruising rather than just treating it after it occurs. ¹

What is the purpose of 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.

Research Team

Daniel Cho, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for individuals seeking facial filler injections and willing to participate in surveys. The study specifically includes those who are suitable candidates for dermal fillers with hyaluronic acid. Details on exclusion criteria were not provided, so it's important to contact the trial organizers for more information.

Inclusion Criteria

I am interested in getting facial filler injections.

English speaking

Exclusion Criteria

I am under 18 years old.

I am over 89 years old.

I am able to make my own medical decisions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive facial filler injections with HA on one half of the face and HA+TXA on the other half

1 day

1 visit (in-person)

Follow-up

Participants are monitored for swelling, bruising, pain, and satisfaction through surveys and medical record reviews

2 weeks

3 visits (in-person or virtual) on days 1, 7, and 14

Treatment Details

Interventions

• Tranexamic Acid

Trial Overview The study tests whether adding Tranexamic Acid (TXA) to Hyaluronic Acid (HA) can reduce bruising, swelling, and pain after HA facial filler injections compared to a saline placebo. Participants will receive standard filler treatment along with either TXA or placebo.

Participant Groups

Group I: Facial Filler Injection Experimental Treatment 3 Interventions

TXA plus HA injection in half of face, saline plus HA injection on other half of face

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Early hyaluronidase use in preventing skin necrosis after treatment with dermal fillers: Report of two cases. [2023]