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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
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Injection Site Bruising Drug: Tranexamic acid Other: Saline Drug: Hyaluronic acid Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bruises

Arms and Interventions
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Arm Intervention/treatment
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
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:
  • HA
  • Hyaluronidase
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
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:
  • HA
  • Hyaluronidase


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Ahmed M Afifi, MD University of Wisconsin, Madison
More Information
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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

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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
Keywords provided by University of Wisconsin, Madison:
patient satisfaction
plastic surgery
Additional relevant MeSH terms:
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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