Clinical trial NCT04373603: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Injection Site Bruising
Keywords: patient satisfaction
plastic surgery
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: half face study where participant serves as own control, intervention on one side of the face, control on the other
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Intensity of Bruising Score
timeFrame: Post procedure day 7
Secondary outcomes:
measure: Intensity of Bruising Score
timeFrame: Post procedure day 1
measure: Intensity of Bruising Score
timeFrame: Post procedure day 30
measure: Intensity of Swelling Score
timeFrame: Post procedure day 1
measure: Intensity of Swelling Score
timeFrame: Post procedure day 7
measure: Intensity of Swelling Score
timeFrame: Post procedure day 30
measure: Pain Score
timeFrame: Post procedure day 1
measure: Pain Score
timeFrame: Post procedure day 7
measure: Pain Score
timeFrame: Post procedure day 30
measure: Participant Satisfaction Score
timeFrame: Post procedure day 1
measure: Participant Satisfaction Score
timeFrame: Post procedure day 7
measure: Participant Satisfaction Score
timeFrame: Post procedure day 30
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ahmed M Afifi, MD
role: PRINCIPAL_INVESTIGATOR
References: