Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-31 @ 2:54 PM
Study NCT ID:
NCT01034956
Status:
COMPLETED
Last Update Posted:
2012-05-01
First Post:
2009-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-29', 'studyFirstSubmitDate': '2009-11-24', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction with treatment with facial soft tissue fillers', 'timeFrame': '0-24 months'}], 'secondaryOutcomes': [{'measure': 'Social and behavioral effects of facial soft tissue filler treatment', 'timeFrame': '0-24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Soft tissue filler', 'Dermal filler', 'Complications', 'Patient satisfaction'], 'conditions': ['Rhytids', 'Wrinkles']}, 'descriptionModule': {'briefSummary': 'Purpose of the study:\n\nThe overall goal of this study is to better understand patient experience with injectable facial fillers so that the investigators may provide the best results for their patients. To do this, the investigators are administering surveys to approximately 50 patients who have been treated by Dr. Anthony P Sclafani, MD, FACS.\n\nParticipation:\n\nParticipants will be asked to complete a brief questionnaire regarding their most recent treatment by Dr. Sclafani with a facial injectable filler. All responses will be analyzed anonymously.', 'detailedDescription': 'Patients previously treated by the PI with dermal fillers will be mailed questionnaires about their experience with the treatment. These questionnaires will be deidentified prior to recording answers on a computer based spreadsheet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years willing to complete the research survey.\n\nExclusion Criteria:\n\n* Any patient not treated by Principal Investigator with facial soft tissue filler within the past 2 years.'}, 'identificationModule': {'nctId': 'NCT01034956', 'briefTitle': 'Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections', 'organization': {'class': 'OTHER', 'fullName': 'The New York Eye & Ear Infirmary'}, 'officialTitle': 'Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections', 'orgStudyIdInfo': {'id': '09.27'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Facial Soft Tissue Filler Patients', 'description': 'Patients previously treated by Principal Investigator with facial soft tissue fillers within the past 2 years', 'interventionNames': ['Device: hyaluronic acid or calcium hydroxylapatite filler']}], 'interventions': [{'name': 'hyaluronic acid or calcium hydroxylapatite filler', 'type': 'DEVICE', 'otherNames': ['Restylane', 'Perlane', 'Juvederm', 'Radiesse'], 'description': 'Intradermal and subdermal injection of facial soft tissue filler within the past 24 months; survey of patients to assess satisfaction and determine the presence of treatment related adverse events.', 'armGroupLabels': ['Facial Soft Tissue Filler Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The New York Eye & Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Anthony P Sclafani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The New York Eye & Ear Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New York Eye & Ear Infirmary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thomas Jefferson University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Facial Plastic Surgery', 'investigatorFullName': 'Anthony P. Sclafani', 'investigatorAffiliation': 'The New York Eye & Ear Infirmary'}}}}