Injection Site BruisingPhase 4NCT04373603
Use of Tranexamic Acid in Facial Fillers
A Phase 4 study testing Tranexamic acid, Saline and Hyaluronic acid in people with Injection Site Bruising, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Bruising
- What is being tested?
- Tranexamic acid, Saline and Hyaluronic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler
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.
- Conditions
- Injection Site Bruising
- Being tested
- Tranexamic acid, Saline, Hyaluronic acid
- Keywords
- patient satisfaction, plastic surgery
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called TXA
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
SalineOther
sodium chloride and water for use as control
Hyaluronic acidDrug
Also called HA, Hyaluronidase
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention: HA plus TXA | Experimental | 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) Receives: Drug: Tranexamic acid; Drug: Hyaluronic acid |
| Control: HA plus Saline | Placebo comparator | HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline Receives: Other: Saline; Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post procedure day 7
Secondary outcomes (11)
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.
Measured: Post procedure day 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.
Measured: Post procedure day 30
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.
Measured: Post procedure day 1
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.
Measured: Post procedure day 7
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.
Measured: Post procedure day 30
Pain Score
Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
Measured: Post procedure day 1
Pain Score
Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.
Measured: Post procedure day 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.
Measured: Post procedure day 30
Participant Satisfaction Score
Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
Measured: Post procedure day 1
Participant Satisfaction Score
Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
Measured: Post procedure day 7
Participant Satisfaction Score
Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.
Measured: Post procedure day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Study closed prior to opening to enrollment, due to funding availability for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site BruisingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- half face study where participant serves as own control, intervention on one side of the face, control on the other
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Afifi, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373603
- Sponsor's protocol ID
- 2020-0573
- Other IDs
- A539730, SMPH/SURGERY/DENTL-PLASTC SRGY, Protocol version 0.11
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler
- ClinicalTrials.gov ID
- NCT04373603
- Acronym / sponsor ID
- 2020-0573
- Conditions
- Injection Site Bruising
- Keywords
- patient satisfaction, plastic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed prior to opening to enrollment, due to funding availability for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- half face study where participant serves as own control, intervention on one side of the face, control on the other
| Arm | Type | Receives |
|---|---|---|
| Intervention: HA plus TXA | Experimental | Drug: Tranexamic acid, Drug: Hyaluronic acidHA 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) |
| Control: HA plus Saline | Placebo comparator | Other: Saline, Drug: Hyaluronic acidHA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: TXATXA is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, thus inhibiting degradation of fibrin clots and serving as an antifibrinolytic | Drug | Intervention: HA plus TXA |
| Salinesodium chloride and water for use as control | Other | Control: HA plus Saline |
| Hyaluronic acidAlso: HA, HyaluronidaseHyaluronidase 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 | Drug | Control: HA plus Saline, Intervention: HA plus TXA |
Primary outcome
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.
11 secondary outcomes
Intensity of Bruising Score
Time frame: Post procedure day 1
Intensity of Bruising Score
Time frame: Post procedure day 30
Intensity of Swelling Score
Time frame: Post procedure day 1
Intensity of Swelling Score
Time frame: Post procedure day 7
Intensity of Swelling Score
Time frame: Post procedure day 30
Pain Score
Time frame: Post procedure day 1
Pain Score
Time frame: Post procedure day 7
Pain Score
Time frame: Post procedure day 30
Participant Satisfaction Score
Time frame: Post procedure day 1
Participant Satisfaction Score
Time frame: Post procedure day 7
Participant Satisfaction Score
Time frame: Post procedure day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Afifi, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid, Saline and Hyaluronic acid in people with Injection Site Bruising, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of Bruising Score (time frame: Post procedure day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.