Hemifacial ParalysisPhase 2NCT05012566
Onabotulinumtoxin A and Hyaluronic Acid Fillers in the Treatment of Facial Paralysis
A Phase 2 study testing Juvederm and Vistabex in people with Hemifacial Paralysis, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemifacial Paralysis
- What is being tested?
- Juvederm and Vistabex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2021to 14 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Integrata
Verona, 37126
Dario Bertossi, Prof, 0458126768, dario.bertossi@univr.it
About this study
Official title: Clinical, Instrumental and Histological Evaluation of the Combined Use of Onabotulinumtoxin A and Hyaluronic Acid Fillers in Patients With Facial Paralysis
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.
Read the 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.
- Conditions
- Hemifacial Paralysis
- Being tested
- Juvederm, Vistabex
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvedermDevice
Also called Hyaluronic Acid
- 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)
VistabexDrug
Also called Botulinum Toxin
Vistabex: 50U/vial, it is injected up to 80U per patient per treatment (2 treatment sessions at a 4 months interval)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 and day 270
Secondary outcomes (13)
Facial Appearance
Facial Appearance will be assessed by FACE-Q Appearance scale measuring different concepts: Area Under Chin, Cheeks, Crows' Feet, Eyes, Forehead \& Eyebrows,Lines Between Eyebrows, Lip Lines, Lower Eyelids, Marionette Line, Neck, Nostrils, Upper Eyelids, Cheekbones, Chin, Eyelashes, Face Overall, Forehead Lines, Lines Overall, Lips, Lower Face \& Jawline, Nasolabial Folds, Nose, Skin.
Each scale is composed of a series of items (or questions) that evaluate a concept of interest. Patient responses to items are on a four-point scale and are asked to answer with their face/facial appearance in mind. Answers for a scale are summed and converted to a score from 0 to 100. A higher score indicates a better outcome.
Measured: Day 0 and day 270.
Health-Related Quality of Life
Health-Related Quality of Life will be assessed by FACE-Q Quality of Life scale measuring different concepts: Age Visual Analogue (score ranging from -15 to +15), Aging Appraisal, Appearance-Related Distress, Early Life Impact of Treatment, Expectations, Psychological Function, Recovery Early Symptoms, Decision Satisfaction, Outcome Satisfaction,Social Function.
Each scale is composed of a series of items (or questions) that evaluate a concept of interest. Patient responses to items are on a four-point scale. Answers for a scale are summed and converted to a score from 0 to 100. For most of these scales, a higher score indicates a better outcome.
Measured: Day 0 and day 270
Adverse Effects
Adverse Effects related to different parts of the face (Cheeks, Lower Face, Neck, Eyes, Forehead, Eyebrows, Scalp, Lips, Nose, Skin) will be assessed by FACE-Q Adverse Effects scales.
Each scale is composed of a series of items (or questions) that evaluate a parts of the face. Patient responses to items are on a three/four-point scale. Answers for a scale are summed and converted to a score from 0 to 100. A higher score indicates a better outcome.
Measured: Day 0 and day 270
Patients experience of care
Patients experience of care related to satisfaction with information, medical team, office staff and with doctor/surgeon will be assessed by FACE-Q experience of care scales.
Each scale is composed of a series of items (or questions) that evaluate the satisfaction. Patient responses to items are on a four-point scale. Answers for a scale are summed and converted to a score from 0 to 100. For all these scales, a higher score indicates a better outcome.
Measured: Day 0 and day 270
Facial symmetry
Facial symmetry will be performed through the analisys of 3D-photography implemented with a face grid, that allows the quantification of symmetry of the face. The face grid permits to calculate the distance in millimeters of two points from the midline (both in vertical and horizontal direction).
Measured: Day 0, day 20, day 150, day 270
Facial aesthetic
Facial aesthetic will be evaluated through the analysis of 3D-photography implemented with a face grid and the Arnett's aesthetic analysis, in order to appreciate the improvement of facial aesthetic.
Measured: Day 0 and day 270
Facial aesthetic - thickness of soft tissue
The thickness of soft tissue will be evaluated using MRI and US (millimetric quantification of the thickness of different areas)
Measured: Day 0 and day 270
Facial aesthetic - thickness of hard tissue
The thickness of hard tissue will be evaluated using CBCT (millimetric quantification of the thickness of the different areas)
Measured: Day 0 and day 270
Facial aesthetic - tropism of muscles
The tropism of muscles will be evaluated using US and cathegorized in atrophy, hypotrophy, eutrophy, hypertrophy.
Measured: Day 0 and day 270
Facial aesthetic - patho-physiological condition
The patho-physiological condition will be evaluated throught an histological analysis that provides a qualitative analysis of injected and not injected tissue and specifically the effects on the fiber muscles
Measured: Day 0 and day 270
Hystological analysis
% of patients with tissue changes assessed by hystological analysis using scanning electron microscope and/or transmission electron microscope provides 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.
Measured: Day 0 and day 270
EMG
EMG provides eletric potentials of the facial neuromuscular complex in order to evaluate the activity and symmetry oh their function.
Measured: Day 0 and day 270
Adverse Events
Registration of number and type of adverse events
Measured: Day 0, day 20, day 30, day 140, day 150, day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start14 Jul 2021
- Primary completion14 Jul 2023 (estimated)
- Study completion14 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- monocenter, no treated controlled group, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Bertossi, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Dario Bertossi, Prof, Principal investigator, AOUI Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012566
- Sponsor's protocol ID
- FACIAL PARALYSIS
- Status last verified
- May 2022
- First submitted
- 25 Jun 2021
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Instrumental and Histological Evaluation of the Combined Use of Onabotulinumtoxin A and Hyaluronic Acid Fillers in Patients With Facial Paralysis
- ClinicalTrials.gov ID
- NCT05012566
- Acronym / sponsor ID
- FACIAL PARALYSIS
- Conditions
- Hemifacial Paralysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 14 Jul 2023 (estimated)
- Study completion
- 14 Jul 2023 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocenter, no treated controlled group, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid filler and Botulinum Toxin group | Experimental | Device: Juvederm, Drug: Vistabex1. 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JuvedermAlso: Hyaluronic Acid* 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) | Device | Hyaluronic Acid filler and Botulinum Toxin group |
| VistabexAlso: Botulinum ToxinVistabex: 50U/vial, it is injected up to 80U per patient per treatment (2 treatment sessions at a 4 months interval) | Drug | Hyaluronic Acid filler and Botulinum Toxin group |
Primary outcome
House-Brackmann scale
Time frame: Day 0 and day 270
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
13 secondary outcomes
Facial Appearance
Time frame: Day 0 and day 270.
Health-Related Quality of Life
Time frame: Day 0 and day 270
Adverse Effects
Time frame: Day 0 and day 270
Patients experience of care
Time frame: Day 0 and day 270
Facial symmetry
Time frame: Day 0, day 20, day 150, day 270
Facial aesthetic
Time frame: Day 0 and day 270
Facial aesthetic - thickness of soft tissue
Time frame: Day 0 and day 270
Facial aesthetic - thickness of hard tissue
Time frame: Day 0 and day 270
Facial aesthetic - tropism of muscles
Time frame: Day 0 and day 270
Facial aesthetic - patho-physiological condition
Time frame: Day 0 and day 270
Hystological analysis
Time frame: Day 0 and day 270
EMG
Time frame: Day 0 and day 270
Adverse Events
Time frame: Day 0, day 20, day 30, day 140, day 150, day 270
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No
Related trials for Hemifacial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario Bertossi, Prof principal investigator
AOUI Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Juvederm and Vistabex in people with Hemifacial Paralysis, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dario Bertossi, Prof (0458126768, dario.bertossi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann scale (time frame: Day 0 and day 270). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.