- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05012566
Onabotulinumtoxin A and Hyaluronic Acid Fillers in the Treatment of Facial Paralysis
Clinical, Instrumental and Histological Evaluation of the Combined Use of Onabotulinumtoxin A and Hyaluronic Acid Fillers in Patients With Facial Paralysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Dario Bertossi, Prof
- Phone Number: 0458126768
- Email: dario.bertossi@univr.it
Study Locations
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-
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Verona, Italy, 37126
- Recruiting
- Azienda Ospedaliera Universitaria integrata
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Contact:
- Dario Bertossi, Prof
- Phone Number: 0458126768
- Email: dario.bertossi@univr.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyaluronic Acid filler and Botulinum Toxin group
Dosage and administration steps will be selected according to the clinical situation. |
Other Names:
Vistabex: 50U/vial, it is injected up to 80U per patient per treatment (2 treatment sessions at a 4 months interval)
Other Names:
|
No Intervention: Control group
The control group will undergo at the same examinations of the treated group but it will not be subjected to any treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Day 0 and day 270
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial Appearance
Time Frame: Day 0 and day 270.
|
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. |
Day 0 and day 270.
|
Health-Related Quality of Life
Time Frame: Day 0 and day 270
|
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. |
Day 0 and day 270
|
Adverse Effects
Time Frame: Day 0 and day 270
|
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. |
Day 0 and day 270
|
Patients experience of care
Time Frame: Day 0 and day 270
|
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. |
Day 0 and day 270
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Facial symmetry
Time Frame: Day 0, day 20, day 150, day 270
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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).
|
Day 0, day 20, day 150, day 270
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Facial aesthetic
Time Frame: Day 0 and day 270
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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.
|
Day 0 and day 270
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Facial aesthetic - thickness of soft tissue
Time Frame: Day 0 and day 270
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The thickness of soft tissue will be evaluated using MRI and US (millimetric quantification of the thickness of different areas)
|
Day 0 and day 270
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Facial aesthetic - thickness of hard tissue
Time Frame: Day 0 and day 270
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The thickness of hard tissue will be evaluated using CBCT (millimetric quantification of the thickness of the different areas)
|
Day 0 and day 270
|
Facial aesthetic - tropism of muscles
Time Frame: Day 0 and day 270
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The tropism of muscles will be evaluated using US and cathegorized in atrophy, hypotrophy, eutrophy, hypertrophy.
|
Day 0 and day 270
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Facial aesthetic - patho-physiological condition
Time Frame: Day 0 and day 270
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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
|
Day 0 and day 270
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Hystological analysis
Time Frame: Day 0 and day 270
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% 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.
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Day 0 and day 270
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EMG
Time Frame: Day 0 and day 270
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EMG provides eletric potentials of the facial neuromuscular complex in order to evaluate the activity and symmetry oh their function.
|
Day 0 and day 270
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Adverse Events
Time Frame: Day 0, day 20, day 30, day 140, day 150, day 270
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Registration of number and type of adverse events
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Day 0, day 20, day 30, day 140, day 150, day 270
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Collaborators and Investigators
Investigators
- Principal Investigator: Dario Bertossi, Prof, AOUI Verona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Virus Diseases
- Infections
- Neurologic Manifestations
- Stomatognathic Diseases
- Mouth Diseases
- DNA Virus Infections
- Cranial Nerve Diseases
- Herpesviridae Infections
- Facial Nerve Diseases
- Paralysis
- Bell Palsy
- Facial Paralysis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Immunologic Factors
- Protective Agents
- Membrane Transport Modulators
- Adjuvants, Immunologic
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Viscosupplements
- Botulinum Toxins
- Botulinum Toxins, Type A
- Hyaluronic Acid
Other Study ID Numbers
- FACIAL PARALYSIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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