## Protocol Section
### Identification Module
**NCT ID:** NCT06430034

**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

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

#### Organization Study ID Info
**ID:** 24IUFC01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2025-11-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-11-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nice

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Peripheral Facial Palsy

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Objective assessment of facial symmetrization after botulinum toxin injection - line

**Time Frame:** Day of injection and 3-4 weeks after.

**Description:** Assessment of static and dynamic symmetry:

superposition of healthy and pathological sides and calculation of RMS (root mean square)

**Measure:** Objective assessment of facial symmetrization after botulinum toxin injection

**Time Frame:** Day of injection and 3-4 weeks after.

**Description:** Assessment of static and dynamic symmetry:

analysis of pre- and post-injection skin displacement vectors, Before and after botulinum toxin injection.

**Measure:** Objective assessment of facial symmetrization after botulinum toxin injection

**Time Frame:** Day of injection and 3-4 weeks after.

#### Secondary Outcomes

**Description:** Measure of symmetrization : degrees of facial palsy.

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

**Time Frame:** Day of injection and 3-4 weeks after.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The inclusion criteria were 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. The exclusion criteria were 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.

Exclusion Criteria: None

-

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** robin.pradel38@gmail.com

**Name:** Robin PRADEL

**Phone:** 0673398497

**Phone Ext:** +33

**Role:** CONTACT

**Contact 2:**

**Email:** savoldelli.c@chu-nice.fr

**Name:** Charles SAVOLDELLI, MD

**Phone:** 0648275014

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nice

**Contacts:**

***Contact 1:***

- **Email:** robin.pradel38@gmail.com

- **Name:** Robin PRADEL

- **Phone:** 0673398497

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Email:** savoldelli.c@chu-nice.fr

- **Name:** Charles SAVOLDELLI, MD

- **Phone:** 0648275014

- **Phone Ext:** +33

- **Role:** CONTACT

**Country:** France

**Facility:** CHU NICE

**State:** Alpes Maritimes

**Status:** RECRUITING

**Zip:** 0600

#### Overall Officials

**Official 1:**

**Affiliation:** Centre Hospitalier Universitaire de Nice

**Name:** Charles SAVOLDELLI

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010243

- Term: Paralysis

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006566

- Term: Herpesviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000005155

- Term: Facial Nerve Diseases

- ID: D000003389

- Term: Cranial Nerve Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M22138

- Name: Bell Palsy

- Relevance: HIGH

- As Found: Facial Palsy

- ID: M8301

- Name: Facial Paralysis

- Relevance: HIGH

- As Found: Facial Palsy

- ID: M21089

- Name: Facies

- Relevance: HIGH

- As Found: Facial

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9643

- Name: Herpesviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M8298

- Name: Facial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6605

- Name: Cranial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T707

- Name: Bell's Palsy

- Relevance: HIGH

- As Found: Facial Palsy

### Condition Browse Module - Meshes

- ID: D000020330

- Term: Bell Palsy

- ID: D000005158

- Term: Facial Paralysis

- ID: D000019066

- Term: Facies

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5183

- Name: Botulinum Toxins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
