Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT04486794
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restylane® for the Treatment of Tear Trough Deformity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients in this current trial will initially be randomized to either needle or cannula injections, or no treatment (control; ratio 3:3:1, respectively). Subjects will proceed from randomization in parallel assignment. Subjects initially randomized to the control group at Baseline will be randomized to either needle or cannula treatment at Visit 3, Month 1 (crossover). Subjects in the crossover group will then be seen at weeks 2 and 4 post last treatment, as per Schedule 1.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-07', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GAIS', 'timeFrame': '1 month', 'description': 'Improvement via the blinded evaluator-assessed Global Aesthetic Improvement Scale (GAIS), at the one-month follow up visit. Improvement will be considered as any point-increase above 0 (no change).'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Baseline to end of study (up to week 10)', 'description': 'Safety measurements will be evaluated by the incidence, seriousness, severity and relationship with the medical device to adverse events reported, at all visits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tear Trough Eyelid Deformity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effectiveness and tolerability of Restylane® for correction of tear trough deformity, using various injection techniques.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female;\n2. Age of 18 years or greater;\n3. Indication for treatment of bilateral tear trough deformity;\n4. Symmetry of tear trough deformity at baseline;\n5. Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure.\n\nExclusion Criteria:\n\n1. Prior (\\<1 year) or planning to undergo any surgery in the corporal area of interest for study;\n2. Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments;\n3. Diabetes mellitus type 1 or type 2;\n4. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;\n5. Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;\n6. Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;\n7. Pregnant or breastfeeding, or wishes to get pregnant within the next 12 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential);\n8. Restylane® should not be used in any person who has hypersensitivity to any of the components of the product;\n9. Active skin inflammation or infection in or near the treatment area;\n10. Possessing any of the contraindications for use of Restylane®;\n11. Septal fat herniation;\n12. Severe elastosis (e.g., dermatochalasis);\n13. Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) within 1 week of treatment.\n14. Use of tear trough injections in the last 12 months.\n15. Use of anterior midface injections in the last 12 months."}, 'identificationModule': {'nctId': 'NCT04486794', 'briefTitle': 'Restylane® for the Treatment of Tear Trough Deformity', 'organization': {'class': 'OTHER', 'fullName': 'Erevna Innovations Inc.'}, 'officialTitle': 'A Clinical Evaluation of the Efficacy and Safety of Hyaluronic Acid (Restylane®) for the Treatment of Tear Trough Deformity', 'orgStudyIdInfo': {'id': '2020-Res-TT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment at baseline', 'interventionNames': ['Device: Restylane®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment at Month 1', 'interventionNames': ['Device: Restylane®']}], 'interventions': [{'name': 'Restylane®', 'type': 'DEVICE', 'description': 'Hyaluronic acid', 'armGroupLabels': ['Treatment at Month 1', 'Treatment at baseline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3R 3A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Erevna Innovations Inc', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Andreas Nikolis, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erevna Innovations Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erevna Innovations Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}