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

NCT05012566 | Unknown Phase 2

• 1 other identifier: FACIAL PARALYSIS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemifacial Paralysis

Outcome Measures

Primary Outcomes (1)

• House-Brackmann scale

  Change from baseline House-Brackmann score at day 270 will be assessed and then compared between the trial groups. The House-Brackmann score is a score to grade the degree of nerve damage in a facial nerve palsy. The measurement is determined by measuring the upwards (superior) movement of the mid-portion of the top of the eyebrow, and the outwards (lateral) movement of the angle of the mouth. Ti is consist of VI level: Grade I - Normal; Grade II - Slight Dysfunction; Grade III - Moderate Dysfunction; Grade IV - Moderate Severe Dysfunction; Grade V - Severe Dysfunction; Grade VI - Total Paralysis

  Day 0 and day 270

Secondary Outcomes (13)

• Facial Appearance

  Day 0 and day 270.

• Health-Related Quality of Life

  Day 0 and day 270

• Adverse Effects

  Day 0 and day 270

• Patients experience of care

  Day 0 and day 270

• Facial symmetry

  Day 0, day 20, day 150, day 270

Study Arms (2)

Hyaluronic Acid filler and Botulinum Toxin group

EXPERIMENTAL

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.

Device: Juvederm; Drug: Vistabex

Control group

NO INTERVENTION

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

Interventions

Juvederm 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)

Also known as: Hyaluronic Acid

Hyaluronic Acid filler and Botulinum Toxin group

Vistabex DRUG

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

Also known as: Botulinum Toxin

Hyaluronic Acid filler and Botulinum Toxin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \> 18 years and \< 65 years
• Hemifacial paralysis from 3 to 6 on the House-Brackmann scale
• Never treated with HA and BTX injection
• Signed informed consent
• Women of childbearing potential will only be included in the study if uptaking hightly effective birth control measures.

You may not qualify if:

• Hypersensitivity to any component of the products used
• 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.
• Pregnant or lactating

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata

Verona, 37126, Italy

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Interventions

Botulinum Toxins, Type A; Botulinum Toxins

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Dario Bertossi, Prof

  AOUI Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario Bertossi, Prof

CONTACT

0458126768; dario.bertossi@univr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., Department of Chirurgia Maxillo-Facciale and Odontostomatologia

Model Details: monocenter, no treated controlled group, randomized clinical trial

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: August 19, 2021
• Study Start: July 14, 2021
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)