Clinical trial NCT05012566: Onabotulinumtoxin A and Hyaluronic Acid Fillers in the Treatment of Facial Paralysis
Official title: Clinical, Instrumental and Histological Evaluation of the Combined Use of Onabotulinumtoxin A and Hyaluronic Acid Fillers in Patients With Facial Paralysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemifacial Paralysis
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocenter, no treated controlled group, randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: House-Brackmann scale
timeFrame: Day 0 and day 270
Secondary outcomes:
measure: Facial Appearance
timeFrame: Day 0 and day 270.
measure: Health-Related Quality of Life
timeFrame: Day 0 and day 270
measure: Adverse Effects
timeFrame: Day 0 and day 270
measure: Patients experience of care
timeFrame: Day 0 and day 270
measure: Facial symmetry
timeFrame: Day 0, day 20, day 150, day 270
measure: Facial aesthetic
timeFrame: Day 0 and day 270
measure: Facial aesthetic - thickness of soft tissue
timeFrame: Day 0 and day 270
measure: Facial aesthetic - thickness of hard tissue
timeFrame: Day 0 and day 270
measure: Facial aesthetic - tropism of muscles
timeFrame: Day 0 and day 270
measure: Facial aesthetic - patho-physiological condition
timeFrame: Day 0 and day 270
measure: Hystological analysis
timeFrame: Day 0 and day 270
measure: EMG
timeFrame: Day 0 and day 270
measure: Adverse Events
timeFrame: Day 0, day 20, day 30, day 140, day 150, day 270
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: AOUI Verona
name: Dario Bertossi, Prof
role: PRINCIPAL_INVESTIGATOR
References: