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

Peripheral Facial Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430034
• Other study ID #: 24IUFC01
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Robin PRADEL
• Phone: 0673398497
• Email: robin.pradel38[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

"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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Facies
• Peripheral Facial Palsy

Locations

Country	Name	City	State
France	CHU NICE	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.