Onabotulinumtoxin A and Hyaluronic Acid Fillers in the Treatment of Facial Paralysis

NCT ID: NCT05012566

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2023-07-14

Brief Summary

Social interaction via facial mimic expression is crucial in human relationship and communication. Neural function disorder in this mechanism therefore affects human communication and social interaction. Facial nerve palsy is the paralysis of any structure innervated by the facial nerve, thus inibiting and severely compromising facial expression. In the last decade a new algorithm of treatment of facial paralysis has been raised. It connects the expertise of Aesthetic Medicine with the expertise of Plastic and Reconstructive Surgery. It is based on the use of Botulinum Toxin (BT) and Hyaluronic Acid (HA fillers). Botulinum toxin is a paralytic toxin that determine flaccid paralysis and is nowadays used in the static correction of facial paralysis with minimal invasiveness, optimal results and no time consumption. The HA fillers has the ability to restore facial volume loss and it is used in the treatment of facial palsy to harmonize symmetry. The aim is to study the effects of the BT and HA in facial paralysis patients in order to understand the efficacy of these products that have never been injected together in this type of patients. Primary objective. To evaluate the functional improvement of facial asymmetries due to facial nerve lesion after the treatment with OnabotulinumtoxinA and hyaluronic acid fillers compared with the untreated group. The evaluation will be performed analyzing the two groups at the baseline (visit 0) and the end of the treatment period (visit 5, after 9 months). Improvement difference of at least 1 grade on the House-Brackmann scale, compared with the untreated group, will be considered clinically significant. Methods. The investigation is randomized open lab phase II single centre clinical trial. This experimental study proposes to evaluate a group of 70 patients affected by hemifacial paralysis of level 3 to 6 on the House-Brackmann scale. 35 patients will be treated (Group A) with both OnabotulinumtoxinA and hyaluronic acid fillers with a monitored follow up. A control group of 35 patients (Group B) who will not be treated, will be enrolled to compare the efficacy of the treatment. During the study all the AE/ADR will be recorded.

Detailed Description

The patients will be evaluated with instrumental (3D pictures, neuro-physiological examination (EMG), radiological [Magnetic Resonance Imaging (MRI)], Cone Beam Computer Tomography (CBCT) and Ultrasound (US)) and non-instrumental analysis (clinical questionnaires and hystological analysis). The histology will be performed with both traditional and electronic approaches. The area of the biopsy will be the paralytic area in the two groups in order to study the soft tissue modulation of the injected molecules. Patient's qiality of life (QoL), through specifically test (FACE-Q), will be also evaluated.

Conditions

Hemifacial Paralysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyaluronic Acid filler and Botulinum Toxin group

1. Hyaluronic Acid filler:

• Juvederm Volbella: it will be used in the softer soft tissue, beacuse its reology is the softest
• Juvederm Volift: it will be used in malar area, because its reology is intermediate between the three products
• Juvederm Voluma: il will be used unstructured area bacause it has the best rheologic characteristics in the reintegration of loss of tissue.

The differents products are going to use in different areas, depending on the area of the paralysis.

2. Botulinum Toxin:

• Vistabex (50U/vial): it is going to be used in the controlateral area of the paralysed face, in order to relax muscle hyper-tonicity.

Dosage and administration steps will be selected according to the clinical situation.

Group Type: EXPERIMENTAL

Juvederm

Intervention Type: DEVICE

• Juvederm Volbella: 15mg/ml, it is injected 1.5ml per patient per treatment (a total of 3ml per patient split in 2 treatment sessions at a 4 months interval);
• Juvederm Volifit: 17.5mg/ml, it is injected 3ml per patient per treatment (a total of 6ml per patient split in 2 treatment sessions at a 4 months interval);
• Juvederm Voluma: 20mg/ml, it is injected 5ml per patient per treatment (a total of 10ml per patient split in 2 treatment sessions at a 4 months interval)

Vistabex

Intervention Type: DRUG

Vistabex: 50U/vial, it is injected up to 80U per patient per treatment (2 treatment sessions at a 4 months interval)

Control group

The control group will undergo at the same examinations of the treated group but it will not be subjected to any treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Juvederm

• Juvederm Volbella: 15mg/ml, it is injected 1.5ml per patient per treatment (a total of 3ml per patient split in 2 treatment sessions at a 4 months interval);
• Juvederm Volifit: 17.5mg/ml, it is injected 3ml per patient per treatment (a total of 6ml per patient split in 2 treatment sessions at a 4 months interval);
• Juvederm Voluma: 20mg/ml, it is injected 5ml per patient per treatment (a total of 10ml per patient split in 2 treatment sessions at a 4 months interval)

Intervention Type: DEVICE

Vistabex

Vistabex: 50U/vial, it is injected up to 80U per patient per treatment (2 treatment sessions at a 4 months interval)

Intervention Type: DRUG

Other Intervention Names

Hyaluronic Acid; Botulinum Toxin

Eligibility Criteria

Inclusion Criteria

1. Aged > 18 years and < 65 years

2. Hemifacial paralysis from 3 to 6 on the House-Brackmann scale

3. Never treated with HA and BTX injection

4. Signed informed consent

5. Women of childbearing potential will only be included in the study if uptaking hightly effective birth control measures.

Exclusion Criteria

1. Hypersensitivity to any component of the products used

2. Diabetes, systemic disease, coronary artery disease, acute-chronic hepatitis C, autoimmune disease and/or other disease involving poor general health clotting problem. Peripheric neuro-musculars disorders, amyotrophic lateral sclerosis.

3. Pregnant or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Dario Bertossi

Prof., Department of Chirurgia Maxillo-Facciale and Odontostomatologia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dario Bertossi, Prof

Role: PRINCIPAL_INVESTIGATOR

AOUI Verona

Locations

Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Dario Bertossi, Prof

Role: CONTACT

dario.bertossi@univr.it

0458126768

Facility Contacts

Dario Bertossi, Prof

Role: primary

dario.bertossi@univr.it

0458126768

Other Identifiers

FACIAL PARALYSIS

Identifier Type: -

Identifier Source: org_study_id