Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-28 @ 6:49 PM
Study NCT ID:
NCT00662961
Status:
COMPLETED
Last Update Posted:
2008-04-21
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forehead Lift Fixation
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-17', 'studyFirstSubmitDate': '2008-04-15', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye brow position', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': "Patients' satisfaction", 'timeFrame': '6 months'}, {'measure': 'Complications', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plastic Surgery'], 'conditions': ['Forehead']}, 'descriptionModule': {'briefSummary': 'To compare periosteum versus bone fixation in forehead lift.', 'detailedDescription': 'Forehead lift method of fixation is variable and lots of different methods have been described with different rates of success.\n\nThe comparison of to different techniques in a RCT has not been reported before.\n\nThe objective is to compare periosteum versus bone fixation in forehead lift, in a randomized, blinded, controlled, split-face trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eye brow malposition\n* Forehead wrinkles\n\nExclusion Criteria:\n\n* Previous surgery\n* Forehead trauma or scar'}, 'identificationModule': {'nctId': 'NCT00662961', 'acronym': 'Forehead', 'briefTitle': 'Forehead Lift Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Uberlandia'}, 'officialTitle': 'Periosteum Versus Bone for the Fixation of Forehead Lift: A Prospective, Randomized, Controlled, Split-Face Trial.', 'orgStudyIdInfo': {'id': '2-Patrocinio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Periosteum', 'interventionNames': ['Procedure: Periosteum']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Bone', 'interventionNames': ['Procedure: Bone']}], 'interventions': [{'name': 'Periosteum', 'type': 'PROCEDURE', 'description': 'Periosteum fixation', 'armGroupLabels': ['1']}, {'name': 'Bone', 'type': 'PROCEDURE', 'description': 'Bone tunnel fixation', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38400-368', 'city': 'Uberlândia', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Uberlandia, Department of ENT/H&N', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}], 'overallOfficials': [{'name': 'Lucas G Patrocinio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Uberlandia, Department of ENT/H&N'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Uberlandia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lucas G. Patrocinio', 'oldOrganization': 'Federal University of Uberlandia'}}}}