Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT04373603
Status:
WITHDRAWN
Last Update Posted:
2022-07-26
First Post:
2020-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Tranexamic Acid in Facial Fillers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D006821', 'term': 'Hyaluronoglucosaminidase'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D011133', 'term': 'Polysaccharide-Lyases'}, {'id': 'D019757', 'term': 'Carbon-Oxygen Lyases'}, {'id': 'D008190', 'term': 'Lyases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'side of face for treatment is randomized and double blinded to the participant and physician'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'half face study where participant serves as own control, intervention on one side of the face, control on the other'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study closed prior to opening to enrollment, due to funding availability for study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of Bruising Score', 'timeFrame': 'Post procedure day 7', 'description': 'Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.'}], 'secondaryOutcomes': [{'measure': 'Intensity of Bruising Score', 'timeFrame': 'Post procedure day 1', 'description': 'Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.'}, {'measure': 'Intensity of Bruising Score', 'timeFrame': 'Post procedure day 30', 'description': 'Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.'}, {'measure': 'Intensity of Swelling Score', 'timeFrame': 'Post procedure day 1', 'description': 'Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.'}, {'measure': 'Intensity of Swelling Score', 'timeFrame': 'Post procedure day 7', 'description': 'Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.'}, {'measure': 'Intensity of Swelling Score', 'timeFrame': 'Post procedure day 30', 'description': 'Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling.'}, {'measure': 'Pain Score', 'timeFrame': 'Post procedure day 1', 'description': 'Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.'}, {'measure': 'Pain Score', 'timeFrame': 'Post procedure day 7', 'description': 'Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.'}, {'measure': 'Pain Score', 'timeFrame': 'Post procedure day 30', 'description': 'Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain.'}, {'measure': 'Participant Satisfaction Score', 'timeFrame': 'Post procedure day 1', 'description': 'Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.'}, {'measure': 'Participant Satisfaction Score', 'timeFrame': 'Post procedure day 7', 'description': 'Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.'}, {'measure': 'Participant Satisfaction Score', 'timeFrame': 'Post procedure day 30', 'description': 'Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient satisfaction', 'plastic surgery'], 'conditions': ['Injection Site Bruising']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 18 but less than or equal to 89 years.\n* Medically appropriate to undergo elective facial filler injection at UW Health by principal investigator\n* English speaking\n\nExclusion Criteria:\n\n* Minors or under the age of 18\n* Patient over the age of 89\n* Pregnant or breast-feeding women\n* Individuals unable to give consent due to another condition such as impaired decision-making capacity.\n* Participants with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis\n* Concurrent use of estrogen\n* Participant undergoing unilateral facial filler injections\n* Participants with history of hypersensitivity to TXA or any of the other ingredients\n* Participants that are on current therapeutic anticoagulation therapy\n* Participants with stage 2 or greater renal failure\n* Participants on hemo- or peritoneal dialysis'}, 'identificationModule': {'nctId': 'NCT04373603', 'briefTitle': 'Use of Tranexamic Acid in Facial Fillers', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler', 'orgStudyIdInfo': {'id': '2020-0573'}, 'secondaryIdInfos': [{'id': 'A539730', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/SURGERY/DENTL-PLASTC SRGY', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol version 0.11', 'type': 'OTHER', 'domain': 'HS-IRB UW, Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: HA plus TXA', '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)', 'interventionNames': ['Drug: Tranexamic acid', 'Drug: Hyaluronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control: HA plus Saline', 'description': 'HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline', 'interventionNames': ['Other: Saline', 'Drug: Hyaluronic acid']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['TXA'], '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', 'armGroupLabels': ['Intervention: HA plus TXA']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'sodium chloride and water for use as control', 'armGroupLabels': ['Control: HA plus Saline']}, {'name': 'Hyaluronic acid', 'type': 'DRUG', 'otherNames': ['HA', 'Hyaluronidase'], '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', 'armGroupLabels': ['Control: HA plus Saline', 'Intervention: HA plus TXA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ahmed M Afifi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}