Use of Tranexamic Acid in Facial Fillers
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ClinicalTrials.gov Identifier: NCT04373603 |
Recruitment Status :
Suspended
(Suspended due to COVID)
First Posted : May 4, 2020
Last Update Posted : January 25, 2021
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Condition or disease | Intervention/treatment | Phase |
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Injection Site Bruising | Drug: Tranexamic acid Other: Saline Drug: Hyaluronic acid | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | half face study where participant serves as own control, intervention on one side of the face, control on the other |
Masking: | Double (Participant, Investigator) |
Masking Description: | side of face for treatment is randomized and double blinded to the participant and physician |
Primary Purpose: | Supportive Care |
Official Title: | Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler |
Estimated Study Start Date : | April 2021 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
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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)
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Drug: Tranexamic acid
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
Other Name: TXA Drug: Hyaluronic acid 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
Other Names:
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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
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Other: Saline
sodium chloride and water for use as control Drug: Hyaluronic acid 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
Other Names:
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- Intensity of Bruising Score [ Time Frame: Post procedure day 7 ]Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.
- Intensity of Bruising Score [ Time Frame: Post procedure day 1 ]Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.
- Intensity of Bruising Score [ Time Frame: Post procedure day 30 ]Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.
- Intensity of Swelling Score [ Time Frame: Post procedure day 1 ]Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.
- Intensity of Swelling Score [ Time Frame: Post procedure day 7 ]Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.
- Intensity of Swelling Score [ Time Frame: Post procedure day 30 ]Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.
- Pain Score [ Time Frame: Post procedure day 1 ]Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
- Pain Score [ Time Frame: Post procedure day 7 ]Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
- Pain Score [ Time Frame: Post procedure day 30 ]Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
- Participant Satisfaction Score [ Time Frame: Post procedure day 1 ]Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
- Participant Satisfaction Score [ Time Frame: Post procedure day 7 ]Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
- Participant Satisfaction Score [ Time Frame: Post procedure day 30 ]Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Medically appropriate to undergo elective facial filler injection at UW Health by principal investigator
- English speaking
Exclusion Criteria:
- 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 (Deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) or genetic disorder that increases risk of thrombosis
- Concurrent use of estrogen

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373603
United States, Wisconsin | |
University of Wisconsin School of Medicine and Public Health | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Ahmed M Afifi, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT04373603 |
Other Study ID Numbers: |
2020-0573 A539730 ( Other Identifier: UW Madison ) SMPH/SURGERY/DENTL-PLASTC SRGY ( Other Identifier: UW Madison ) |
First Posted: | May 4, 2020 Key Record Dates |
Last Update Posted: | January 25, 2021 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
patient satisfaction plastic surgery |
Contusions Wounds, Nonpenetrating Wounds and Injuries Tranexamic Acid Hyaluronic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
Hemostatics Coagulants Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |