Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT01775293
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2013-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh
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': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration', 'timeFrame': 'change in the WSRS from baseline at7 week', 'description': 'The efficacy is assessed by the severity of the fold determined by the WSRS assessed by the investigator with photos WSRS(Wrinkle Severity Rating Scale)is be evaluated from 1 to 5 according to the severity of wrinkles\n\n(1= no visible fold, 5= extremely deep and long fold)'}], 'secondaryOutcomes': [{'measure': 'The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration', 'timeFrame': 'Changes Satisfaction from baseline at 7week', 'description': 'The changes in the satisfaction(VAS-visual analog scale) of the pre and post rhytidectomy from baseline at 7week after administration VAS(visual analog scale)is to be evaluated from 0 to 100 by the participant ( 0= no wrinkle, 100= severe wrinkle)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-absorbable polypropylene mesh', 'WSRS', 'Rhytidectomy'], 'conditions': ['Nasolabial Fold']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy and safety of the investigational device, RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.\n\nStudy hypothesis\n\n* level of significance: alpha=0.05( two-side)\n* power of test: (power= 1-beta),power=0.08\n* H0: P equals P0\n* H1: P unequals P0\n* The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)', 'detailedDescription': '1\\. Benefits\n\n* enhancing self-satisfaction and quality of life by improving skin elasticity and correcting folds in the nasolabial fold area 2. Risks\n* erythema, swelling, pain and redness in the facial area generally resolve in 1 week 3.Duration of study\n* entire duration: approximate 36weeks\n* Follow-up period: 7 weeks\n* Enrollment period: 12 weeks 4. study design\n* 2 step operation process\n\n * First step- insert polypropylene mesh under the skin\n * Second step- pull the polypropylene mesh 3 weeks later'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who had soft tissue sagging around nasolabial fold\n* Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS)\n* Subjects who voluntary decided to participate in the study and signed the informed consent\n\nExclusion Criteria:\n\n* Subjects who have a skin disease on the face\n* Subjects who have severe facial skin disease\n* Subjects who are constantly taking anti-coagulants including aspirin\n* Subjects who have too thin or thick skin\n* Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease\n* Subjects who had an allergy to non-absorbable material.\n* Subjects who are taking immune suppressants\n* General weakness status\n* Pregnant or lactating women\n* Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease,\n* Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face\n* Subjects who participated in other clinical trial within 30 days from screening'}, 'identificationModule': {'nctId': 'NCT01775293', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Multi Center, Non-comparative Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety After Rhytidectomy Using Non-absorbable Mesh(RPM)', 'orgStudyIdInfo': {'id': 'E-1209-170-002'}, 'secondaryIdInfos': [{'id': '06-2012-208', 'type': 'OTHER', 'domain': 'Seoul National University Bundang Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-absorbable polypropylene mesh', 'description': '2 step procedures\n\n* first step is insertion of Non-absorbable polypropylene mesh under the facial skin\n* second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step', 'interventionNames': ['Device: Non-absorbable polypropylene mesh']}], 'interventions': [{'name': 'Non-absorbable polypropylene mesh', 'type': 'DEVICE', 'description': '2 step procedures\n\n* first step is insertion of Non-absorbable polypropylene mesh under the facial skin\n* second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step', 'armGroupLabels': ['Non-absorbable polypropylene mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'state': 'Seongbukgu/Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chanyeong Heo, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'D.med', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}