Onabotulinumtoxin A and Hyaluronic Acid Fillers in the Treatment of Facial Paralysis
Hemifacial Paralysis
About this trial
This is an interventional treatment trial for Hemifacial Paralysis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Azienda Ospedaliera Universitaria IntegrataRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Hyaluronic Acid filler and Botulinum Toxin group
Control group
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. 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.
The control group will undergo at the same examinations of the treated group but it will not be subjected to any treatment.