Back to resultsUse of Tranexamic Acid in Facial Fillers
Primary Purpose
Injection Site Bruising
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Saline
Hyaluronic acid
Sponsored by
About this trial
This is an interventional supportive care trial for Injection Site Bruising focused on measuring patient satisfaction, plastic surgery
Eligibility Criteria
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:
- 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 hypersensitivity 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
Sites / Locations
- University of Wisconsin School of Medicine and Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention: HA plus TXA
Control: HA plus Saline
Arm Description
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)
HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Pain Score
Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
Pain Score
Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
Pain Score
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
Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
Participant Satisfaction Score
Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
Participant Satisfaction Score
Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
Full Information
NCT ID
NCT04373603
First Posted
April 28, 2020
Last Updated
July 21, 2022
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04373603
Brief Title
Use of Tranexamic Acid in Facial Fillers
Official Title
Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study closed prior to opening to enrollment, due to funding availability for study
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injection Site Bruising
Keywords
patient satisfaction, plastic surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
half face study where participant serves as own control, intervention on one side of the face, control on the other
Masking
ParticipantInvestigator
Masking Description
side of face for treatment is randomized and double blinded to the participant and physician
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: HA plus TXA
Arm Type
Experimental
Arm Description
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)
Arm Title
Control: HA plus Saline
Arm Type
Placebo Comparator
Arm Description
HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
TXA
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
sodium chloride and water for use as control
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Other Intervention Name(s)
HA, Hyaluronidase
Intervention Description
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
Primary Outcome Measure Information:
Title
Intensity of Bruising Score
Description
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 Outcome Measure Information:
Title
Intensity of Bruising Score
Description
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
Title
Intensity of Bruising Score
Description
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
Title
Intensity of Swelling Score
Description
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
Title
Intensity of Swelling Score
Description
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
Title
Intensity of Swelling Score
Description
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
Title
Pain Score
Description
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
Title
Pain Score
Description
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
Title
Pain Score
Description
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
Title
Participant Satisfaction Score
Description
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
Title
Participant Satisfaction Score
Description
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
Title
Participant Satisfaction Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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 hypersensitivity 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Afifi, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Tranexamic Acid in Facial Fillers
We'll reach out to this number within 24 hrs