Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-25 @ 11:07 PM
Study NCT ID:
NCT02636894
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2015-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2015-12-16', 'studyFirstSubmitQcDate': '2015-12-17', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)', 'timeFrame': '6 months', 'description': 'Improvement of subjects based on 5 point global aesthetic scale (GAIS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smile Lines']}, 'descriptionModule': {'briefSummary': 'Filler study for smile lines in cheek folds'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between 21-65 years of age\n* Willing to comply with study visits and procedures\n* Willingness to refrain form surgical, laser, or injectable treatments in cheek region during study\n\nExclusion Criteria:\n\n* History of trauma, acne scarring, burns, or other changes to skin in treatment area\n* Use of botulinum toxin in the lateral cheeks/perioral region in past 6 months\n* Use of injectable fillers in the lateral cheeks/perioral within last 2 years\n* History of facelift in the last year\n* History of facial nerve palsy'}, 'identificationModule': {'nctId': 'NCT02636894', 'briefTitle': 'Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)', 'organization': {'class': 'OTHER', 'fullName': 'Nashville Centre for Laser and Facial Surgery'}, 'officialTitle': 'Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)', 'orgStudyIdInfo': {'id': 'Restylane Silk'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Restylane Silk', 'description': 'Restylane Silk', 'interventionNames': ['Device: Restylane Silk']}], 'interventions': [{'name': 'Restylane Silk', 'type': 'DEVICE', 'armGroupLabels': ['Restylane Silk']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amanda D. Spear, CCRC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Brian Biesman, MD', 'investigatorFullName': 'Amanda D. Spear, CCRC', 'investigatorAffiliation': 'Nashville Centre for Laser and Facial Surgery'}}}}