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临床试验/NCT06430034
NCT06430034招募中不适用

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

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Objective assessment of facial symmetrization after botulinum toxin injection - line

研究概览

简要总结

"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."

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Objective assessment of facial symmetrization after botulinum toxin injection - line

时间窗: Day of injection and 3-4 weeks after.

Assessment of static and dynamic symmetry: bi-pupillary line / bi-commissural line angle - measure in degrees

Objective assessment of facial symmetrization after botulinum toxin injection

时间窗: Day of injection and 3-4 weeks after.

Assessment of static and dynamic symmetry: analysis of pre- and post-injection skin displacement vectors, Before and after botulinum toxin injection.

次要结局

  • Evaluation of the importance of symmetrization based on injection patterns, types, and degrees of facial palsy.(Day of injection and 3-4 weeks after.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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