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

Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization Through Botulinum Toxin Injections, in Patients With Peripheral Facial Palsy

"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.

The 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."

Study Overview

• Status: Recruiting
• Conditions: Peripheral Facial Palsy

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Robin PRADEL; Phone Number: +33 0673398497; Email: robin.pradel38@gmail.com
• Study Contact Backup: Name: Charles SAVOLDELLI, MD; Phone Number: +33 0648275014; Email: savoldelli.c@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 0600
      • Recruiting
      • CHU Nice
      • Contact: Robin PRADEL; Phone Number: +33 0673398497; Email: robin.pradel38@gmail.com
      • Contact: Charles SAVOLDELLI, MD; Phone Number: +33 0648275014; Email: savoldelli.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France

Description

Inclusion Criteria:

-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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective assessment of facial symmetrization after botulinum toxin injection - line	Assessment of static and dynamic symmetry: bi-pupillary line / bi-commissural line angle - measure in degrees	Day of injection and 3-4 weeks after.
Objective assessment of facial symmetrization after botulinum toxin injection	Assessment of static and dynamic symmetry: superposition of healthy and pathological sides and calculation of RMS (root mean square)	Day of injection and 3-4 weeks after.
Objective assessment of facial symmetrization after botulinum toxin injection	Assessment of static and dynamic symmetry: analysis of pre- and post-injection skin displacement vectors, Before and after botulinum toxin injection.	Day of injection and 3-4 weeks after.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the importance of symmetrization based on injection patterns, types, and degrees of facial palsy.	Measure of symmetrization : degrees of facial palsy.	Day of injection and 3-4 weeks after.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Charles SAVOLDELLI, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Facial Nerve Diseases; Bell Palsy; Facial Paralysis; Facies
• Other Study ID Numbers: 24IUFC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No