hemifacial paralysis (3 to 6 of the House-Brackmann scale) MedDRA version: 20.1 Level: LLT Classification code 10016060 Term: Facial palsy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: VISTABEX - 4 UNITA'/0.1 ML POLVERE PER SOLUZIONE INIETTABILE FLACONCINO DA 50 UNITA'
Product Name: VISTABEX
Product Code: [TOSSINA BOTULINICA DI TIPO A]
Pharmaceutical Form: Powder for so
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (18-65) with hemifacial paralysis from 3 to 6 on the House-Brackmann scale, never treated with HA and BTX injection will be included in the study. - Signed informed consent. - Women of childbearing potential will only be included in the study if uptaking the following highly effective birth control measures: Women of childbearing potential will only be included in the study if uptaking the following highly effective birth control measures: - Combined hormonal contraception associated with inhibition of ovulation (Oral, Transdermal, Intravaginal), - Progesteron-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable), - Intrauterine devices, - Intrauterine hormone-releasing system, - Bilateral tubal occlusion, - vasectomized partner, - Sexual abstinence - Patients will be included after a negative highly sensitive pregnancy test (blood test) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Hypersensitivity to any component of the products used - Diabetes, systemic diseases, coronary artery disease, acute-chronic hepatitis C, autoimmune diseases and / or other diseases involving poor general health, clotting problem. Peripheric neuro-muscolars disorders, amyotrophic lateral sclerosis (ALS). - Pregnant or lactating - Patients 65 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the functional (muscular enhancement) 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 and at the end of the treatment period.;Secondary Objective: Group A -Evaluation of QoL, assessed through questionnaire before and after treatment (Visit 0 vs Visit 5) -Quantify and evaluate the improvement facial symmetry obtained by treatments (Visit 0, Visit 1, Visit 4 and Visit 5). -Aesthetic and Functionality, assessed through questionnaire, 3D photos, MRI, CBCT, US, Histological and EMG tests to underline treatment improvement on facial neuromuscular complex (Visit 0 vs Visit 5). -Evaluate adverse events and safety of the treatments Group A vs Group B -Evaluation of QoL, assessed through questionnaire (Visit 5) -Aesthetic and Functionality, assessed through questionnaire, 3D photos, MRI, CBCT, US, Histological and EMG tests on facial neuromuscular complex (Visit 5).;Primary end point(s): House-Brackmann scale score. La differenza di miglioramento di almeno 1 grado sulla scala House-Brackmann, rispetto al gruppo non trattato, sarà considerata clinicamente significativa;Timepoint(s) of evaluation of this end point: Visit 0 vs Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Visit 0, Visit 1, Visit 2, Visit 3, Visit 4 and Visit 5; Visit 5; Visit 5; Visit 0 and Visit 5; Visit 0, Visit 1, Visit 4 and Visit 5; Visit 0, Visit 5;Secondary end point(s): Number and type of adverse events; Evaluation of QoL assessed through FACE-Q questionnaire in both groups; Facial aesthetic will be evaluated in both groups through: - the analysis of 3D-photography implemented with a face grid and the Arnett’s aesthetic analysis. Arnett’s aesthetic analysis evaluate the different areas of the face as “flat”, “soft”, “normal” and “protruded” -MRI provides quantitative data on the thickness of soft tissue (millimetric quantification of the thickness of the different areas) -CBCT provides quantitative data on the thickness of hard tissue (millimetric quantification of the thickness of the different areas) -US provides quantitative data on the thickness of soft tissue (millimetric quantification of the thickness of the different areas) and qualitative data on the tropism of muscules (Atrophy, hypotrophy, eutrophy, hypertrophy) -Histological analysis provides a qualitative analysis of patho-physiological condition of injected and not-injected tissue and specifically the effects on the fiber muscles. Histological and imaging (SEM and/or TEM) analysis should provide a through examination of tissue changes due to the physical introduction of the products, comparing different conditions in injected and not-injected tissue and eventually any effect on the fiber muscles. Possible physical and mechanical effect on treated tissues will be evaluated by histological evaluation to characterize tissue and cells involved in the modification, including the emergence and/or change of resident populations via the application of straightforward approaches. Histological evidence is then supported and completed with TEM and /or SEM. -EMG provides electric potentials of the facial neuromuscular complex in order to evaluate the activity an | — |
Countries
Italy
Contacts
Public ContactUnità Ricerca Clinica
AOUI Verona
Outcome results
None listed