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

NCT ID: NCT06430034

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

"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."

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Facial Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charles SAVOLDELLI

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU NICE

Nice, Alpes Maritimes, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Robin PRADEL

Role: CONTACT

0673398497 ext. +33

Charles SAVOLDELLI, MD

Role: CONTACT

0648275014 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Robin PRADEL

Role: primary

0673398497 ext. +33

Charles SAVOLDELLI, MD

Role: backup

0648275014 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24IUFC01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dysport® Adult Upper Limb Spasticity
NCT01313299 COMPLETED PHASE3