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

NCT06430034 | Recruiting

• 1 other identifier: 24IUFC01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Peripheral Facial Palsy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Evaluation of the importance of symmetrization based on injection patterns, types, and degrees of facial palsy.

  Day of injection and 3-4 weeks after.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 0600, France

RECRUITING

Study Officials

• Charles SAVOLDELLI

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin PRADEL

CONTACT

0673398497; robin.pradel38@gmail.com

Charles SAVOLDELLI, MD

CONTACT

0648275014; savoldelli.c@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

FR (1)