An observational study in Peripheral Facial Palsy, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
"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."
81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 21 observational studies indexed under Facial Paralysis.
Browse Facial Paralysis studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
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Patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France
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-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:
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
Time frame: 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)
Time frame: 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.
Time frame: Day of injection and 3-4 weeks after.
Evaluation of the importance of symmetrization based on injection patterns, types, and degrees of facial palsy.
Measure of symmetrization : degrees of facial palsy.
Time frame: Day of injection and 3-4 weeks after.
Started Nov 2023 (actual). Primary completion is estimated for Nov 2025, 24 months after the start.
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