Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT04162002
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2019-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions.', 'timeFrame': '4 weeks', 'description': 'Subjects will have a picture of their hand evaluated by third party physicians on the basis of:\n\nSocial Skills Positive mood, gets along with others well, friendly 1-10 rating\n\nAcademic Performance Intelligent, highly educated, received good grades in school 1-10 rating\n\nDating Success Dates frequently, lacks dating anxiety 1-10 rating\n\nOccupational Success Good worker, competent, motivated for success, suitable as potential employee 1-10 rating\n\nAttractiveness Pleasing appearance 1-10 rating\n\nFinancial Success Has achieved financial success, member of a high social class 1-10 rating\n\nRelationship Success Willingness to compromise, ability to maintain long term friendships 1-10 rating\n\nAthletic Success Excels at athletic skills, plays individual and/or team sports 1-10 rating'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Rejuvination']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine the effects of Restylane® Lyft Filler injection into the back of the hand on first impressions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '28 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females of ages 28 and above.\n2. Subjects will be required not to have had previous filler fat injections, or other cosmetic treatments to their hands within the last 12 months.\n3. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit. -\n\nExclusion Criteria:\n\n1. Males and females below age of 28.\n2. Subjects who have had previous filler, fat injections, or other cosmetic treatments to their hands within the last 12 months.\n3. Subjects who are pregnant or nursing.\n4. Subjects with a known allergy or sensitivity to any component of the study ingredients.\n5. Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.\n6. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.\n7. Subjects with diseases, injuries, or disabilities of the hand, including those with autoimmune disease affecting the hand, hand implants, Dupuytren's contracture, history of hand tumor, vascular malformations, Raynaud's disease and patients at risk for tendon rupture.\n8. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded. -"}, 'identificationModule': {'nctId': 'NCT04162002', 'briefTitle': 'Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions', 'organization': {'class': 'OTHER', 'fullName': 'DeNova Research'}, 'officialTitle': 'Effects of Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions', 'orgStudyIdInfo': {'id': 'REST- HAN-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restylane® Lyft Filler Injection', 'interventionNames': ['Drug: Restylane® Lyft']}], 'interventions': [{'name': 'Restylane® Lyft', 'type': 'DRUG', 'description': 'Filler Injection', 'armGroupLabels': ['Restylane® Lyft Filler Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'DeNova Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Steven Dayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DeNova Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DeNova Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Galderma R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Assistant Professor', 'investigatorFullName': 'Steven H. Dayan', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}