Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430034
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-21
Brief Title:
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
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization Through Botulinum Toxin Injections in Patients With Peripheral Facial Palsy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None