Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-04-13 @ 10:21 PM
Study NCT ID:
NCT06430034
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization by Botulinum Toxin Injections. Study of Facial Symmetry Before and After Botulinum Toxin Injections on the Face of Patients Suffering From Sequellar Peripheral Facial Paralysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective assessment of facial symmetrization after botulinum toxin injection - line', 'timeFrame': 'Day of injection and 3-4 weeks after.', 'description': 'Assessment of static and dynamic symmetry: bi-pupillary line / bi-commissural line angle - measure in degrees'}, {'measure': 'Objective assessment of facial symmetrization after botulinum toxin injection', 'timeFrame': 'Day of injection and 3-4 weeks after.', 'description': 'Assessment of static and dynamic symmetry:\n\nsuperposition of healthy and pathological sides and calculation of RMS (root mean square)'}, {'measure': 'Objective assessment of facial symmetrization after botulinum toxin injection', 'timeFrame': 'Day of injection and 3-4 weeks after.', 'description': 'Assessment of static and dynamic symmetry:\n\nanalysis of pre- and post-injection skin displacement vectors, Before and after botulinum toxin injection.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the importance of symmetrization based on injection patterns, types, and degrees of facial palsy.', 'timeFrame': 'Day of injection and 3-4 weeks after.', 'description': 'Measure of symmetrization : degrees of facial palsy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Facial Palsy']}, 'descriptionModule': {'briefSummary': '"This is a prospective, single-center study. The main objective of our study will be to objectively evaluate the improvement of facial symmetry after botulinum toxin injection on the face in patients suffering from sequelae of peripheral facial paralysis. A secondary objective will be to assess the utility of 3D photography and stereophotogrammetry to detect and quantify facial changes relevant to this type of treatment. The number of patients included in the study is expected to be 15 at minimum. Our study will rely on 3D photographs taken with the Vectra H2 Imaging System camera device (Canfield Scientific, Inc., Fairfield, New Jersey), which will be captured before and 3 weeks to 1 month after botulinum toxin injection into the facial muscles. Various analyses of static and dynamic symmetry will be performed using the Vectra software: bi-pupillary line angle / bi-commissural line angle, superposition of healthy and pathological sides followed by RMS (root mean square) calculation, analysis of pre- and post-injection skin displacement vectors.\n\nThe results of these analyses will allow conclusions to be drawn regarding the objective efficacy of botulinum toxin injections for facial symmetrization in patients with peripheral facial paralysis, as well as to adapt injection patterns based on the severity of facial paralysis."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France at Head and Neck Institute, Nice, France.\n\nExclusion Criteria:\n\n* History of corrective surgery for facial palsy, significant facial surgery, neurodegenerative diseases, the presence of skin imperfections or facial tumors that would impede a rigorous analysis of wrinkles and facial movements.'}, 'identificationModule': {'nctId': 'NCT06430034', 'briefTitle': 'Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization by Botulinum Toxin Injections. Study of Facial Symmetry Before and After Botulinum Toxin Injections on the Face of Patients Suffering From Sequellar Peripheral Facial Paralysis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization Through Botulinum Toxin Injections, in Patients With Peripheral Facial Palsy', 'orgStudyIdInfo': {'id': '24IUFC01'}}, 'contactsLocationsModule': {'locations': [{'zip': '0600', 'city': 'Nice', 'state': 'Alpes Maritimes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Robin PRADEL', 'role': 'CONTACT', 'email': 'robin.pradel38@gmail.com', 'phone': '0673398497', 'phoneExt': '+33'}, {'name': 'Charles SAVOLDELLI, MD', 'role': 'CONTACT', 'email': 'savoldelli.c@chu-nice.fr', 'phone': '0648275014', 'phoneExt': '+33'}], 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Robin PRADEL', 'role': 'CONTACT', 'email': 'robin.pradel38@gmail.com', 'phone': '0673398497', 'phoneExt': '+33'}, {'name': 'Charles SAVOLDELLI, MD', 'role': 'CONTACT', 'email': 'savoldelli.c@chu-nice.fr', 'phone': '0648275014', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Charles SAVOLDELLI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}