Onabotulinumtoxin A and Hyaluronic Acid Fillers in the Treatment of Facial Paralysis
Status:
Recruiting
Trial end date:
2023-07-14
Target enrollment:
Participant gender:
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.