Facial PalsyNCT04237961
Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes
A study testing Botox and brow lift, Injection and Suture in people with Facial Palsy, run by Assiut University at 1 site in Egypt.
Trial summary
Introduction: There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Palsy
- What is being tested?
- Botox and brow lift, Injection and Suture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 28 Mar 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with refractory Facial Palsy who did not respond well to other concerned interferences and those who presented the maximum benefit possible of a performed procedure.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit university
Asyut, Assuit, 71515
Mohamed Alshazly Alshazly, Professor, +20100666795, Eshazly@aun.edu.eg
Ahmed Tohamy Tohamy, Doctor, +201221783834, ahmedtohamy92@gmail.com
About this study
Introduction:
There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821.
Read more
Virally triggered, acute FP, to which the term Bell's palsy (BP) refers, is one of the most common, and fortunately the most likely condition to result in eventual return to premorbid status; 70% to 90% of patients recover spontaneously. Other causes of FP routinely result in poorer recovery, and the clinician must discern among these to formulate a treatment plan.
In facial palsy, paralysis of muscles on the affected side of the face results in loss of forehead creases, loss of the nasolabial fold, lagophthalmos, brow droop, and drooping of the corner of the mouth. In contrast, muscles on the unaffected side of the face no longer have opposing forces.
This may cause difficulty in articulation, eating, drinking, and is often cosmetically unacceptable to patients because of asymmetry, especially when speaking, smiling, and laughing. There are significant psychological effects as patients lack the confidence to carry out many daily activities in public, such as appearing in photographs.
Although management is difficult, there are a range of reanimation options available. These include nerve grafts, muscle transfers, myofunctional approaches, and microsurgical patches usually for the more severe facial palsies (House-Brackmann grades 4 to 6). However, despite these procedures, facial symmetry may not improve.
Read the detailed description
Ancillary procedures in patients of refractory facial palsy. Patients selection and evaluation of the outcomes.
Introduction:
There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821.
Virally triggered, acute FP, to which the term Bell's palsy (BP) refers, is one of the most common, and fortunately the most likely condition to result in eventual return to premorbid status; 70% to 90% of patients recover spontaneously. Other causes of FP routinely result in poorer recovery, and the clinician must discern among these to formulate a treatment plan.
In facial palsy, paralysis of muscles on the affected side of the face results in loss of forehead creases, loss of the nasolabial fold, lagophthalmos, brow droop, and drooping of the corner of the mouth. In contrast, muscles on the unaffected side of the face no longer have opposing forces.
This may cause difficulty in articulation, eating, drinking, and is often cosmetically unacceptable to patients because of asymmetry, especially when speaking, smiling, and laughing. There are significant psychological effects as patients lack the confidence to carry out many daily activities in public, such as appearing in photographs.
Although management is difficult, there are a range of reanimation options available. These include nerve grafts, muscle transfers, myofunctional approaches, and microsurgical patches usually for the more severe facial palsies (House-Brackmann grades 4 to 6). However, despite these procedures, facial symmetry may not improve.
Refractory Facial Palsy:
Facial paralysis is a rare disorder, but it has significant effects on an individual, both physical and emotional. While most patients fully recover from acute facial paralysis, a small population is left with chronic lingering symptoms. Refractory patients are those who had the maximum benefit of a performed procedure and need some fine touches and also those who did not recover well of the initial condition.
Aim of the Work:
This study is aimed to evaluate the outcome of ancillary procedures in refractory cases of facial palsy and to introduce both simple and sophisticated techniques to those patients presented to the investigator's department.
Inclusion Criteria:
Patients with refractory Facial Palsy who did not respond well to other concerned interferences and those who presented the maximum benefit possible of a performed procedure.
Patients \& Methods:
This study will be conducted on 20 patients attendance outpatient clinic of plastic surgery department - Assiut University Hospital.
Patients could be divided into three groups according to the anatomical site of interferences:
- Group 1: Upper third interferences
- Group 2: Mid third interferences
- Group 3: Lower third interferences Methodology
- Botulinum toxin A (BTXA) has been used since the 1970s to treat a variety of conditions resulting in abnormal muscle contraction or spasm. It works by preventing the release of acetylcholine into the neuromuscular junction thereby inhibiting muscle contraction.2 Its benefits in synkinesis in facial palsy (aberrant neural regeneration of the paralysed muscles) are well recognized.
BTXA was injected into the contralateral lower facial muscles complex to weaken the unopposed normal muscles to improve symmetry, both active and passive.
- Gold/Platinum weight implants Implantable devices have been used to restore dynamic lid closure in cases of severe, symptomatic lagophthalmos. These procedures are best for patients with poor Bell phenomenon and decreased corneal sensation. Gold or platinum weights, a weight-adjustable magnet, or palpebral springs can be inserted into the eyelids. Pretarsal gold-weight implantation is most commonly performed.
The implants are inert and composed of 99.99% pure gold or platinum. Sizes range from 0.6-1.8 g. The weight allows the upper eyelid to close with gravity when the levator palpebrae are relaxed. Therefore, patients must sleep with their head slightly elevated.
The implants are easily removed if nerve function returns. Complications include migration of the implant, inflammation, allergic reaction, and extrusion.
- Tarsorrhaphy Tarsorrhaphy decreases horizontal lid opening by fusing the eyelid margins together, increasing support of the precorneal lack of tears and improving coverage of the eye during sleep. The procedure can be done in the office and is particularly suitable for patients who are unable or unwilling to undergo other surgery.
Tarsorrhaphy can be performed laterally, centrally, or medially. The lateral procedure is the most common; however, it can restrict the monocular temporal visual field.
- Brow lifting Brow ptosis is repaired with a direct brow lift. Care should be taken in the presence of corneal decompensation because lifting the brow can cause worsening of lagophthalmos, especially if lid closure is poor. A gold-weight implant can be placed or lower-lid resuspension can be performed simultaneously to prevent this complication
- Suspension suture Static facial suspension procedures stabilise the muscles of mid-face paralysis and provide facial symmetry, a better aesthetic appearance, improved chewing and speech production in patients with facial paralysis. The new generation of Silhouette wires for tissue suspension is a significant improvement with respect to gold threads or Russian threads. They provide a new method of anchoring since they are made of polypropylene with absorbable cones of polylactic acid and glycolic acid. This suture allows tissue growth in and around the cones and therefore a strangerhood.
They were approved by the FDA in November 2006 and by the EEC in March 2007. They have been used in over 6,000 mid-face facial aesthetic surgery interventions in the U.S. and Europe and have recently begun to be used to treat facial paralysis.
- Fat injection Fat transfer to the face uses the patient's own adipose tissue (collected with a minor liposuction procedure from the belly or back), which gives volume and shape to the affected parts of the face, as well as impart glow and sheen to the skin
- Lateral Canthoplasty: canthoplasty may be considered as one of the most valuable oculoplastic surgical procedures to correct lid abnormalities. The indications include ectropion, entropion, lateral canthal dystopia, horizontal lid laxity, lid margin eversion.
Evaluation of outcome:
-Subjective:- 3 Plastic surgeon will be commenting on the pre and post photography regarding to normal side .
-Objective:- measurement between normal and effected side of the position eye brow ,Palpebral fissure, and angle of the mouth
- Conditions
- Facial Palsy
- Being tested
- Botox and brow lift, Injection, Suture
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox and brow liftProcedure or surgery
Botox injection
InjectionProcedure or surgery
Fat injection and botox
SutureProcedure or surgery
Suspension suture
| Study group | Role | What they receive |
|---|---|---|
| Upper third interference | Experimental | Botox \& brow lift Receives: Procedure: Botox and brow lift |
| Middle third | Experimental | Botox and fat injection Receives: Procedure: Injection |
| Lower third | Experimental | Suspension suture Receives: Procedure: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes
measurement the change in vertical length of the palpebral fissure of the affected eye before and after the operation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Jan 2019
- Primary completion28 Jan 2020 (estimated)
- Study completion28 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients could be divided into three groups according to the anatomical site of interferences: * Group 1: Upper third interferences * Group 2: Mid third interferences * Group 3: Lower third interferences
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, saleh ali ibrahim elazoumi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237961
- Sponsor's protocol ID
- Assiutu123
- Status last verified
- Jan 2020
- First submitted
- 25 Mar 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients Selection and evaluation of the outcome.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes
- ClinicalTrials.gov ID
- NCT04237961
- Acronym / sponsor ID
- Assiutu123
- Conditions
- Facial Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Jan 2020 (estimated)
- Study completion
- 28 Mar 2020 (estimated)
- First posted
- 23 Jan 2020 (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.
Introduction:
There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821.
Virally triggered, acute FP, to which the term Bell's palsy (BP) refers, is one of the most common, and fortunately the most likely condition to result in eventual return to premorbid status; 70% to 90% of patients recover spontaneously. Other causes of FP routinely result in poorer recovery, and the clinician must discern among these to formulate a treatment plan.
In facial palsy, paralysis of muscles on the affected side of the face results in loss of forehead creases, loss of the nasolabial fold, lagophthalmos, brow droop, and drooping of the corner of the mouth. In contrast, muscles on the unaffected side of the face no longer have opposing forces.
This may cause difficulty in articulation, eating, drinking, and is often cosmetically unacceptable to patients because of asymmetry, especially when speaking, smiling, and laughing. There are significant psychological effects as patients lack the confidence to carry out many daily activities in public, such as appearing in photographs.
Although management is difficult, there are a range of reanimation options available. These include nerve grafts, muscle transfers, myofunctional approaches, and microsurgical patches usually for the more severe facial palsies (House-Brackmann grades 4 to 6). However, despite these procedures, facial symmetry may not improve.
Detailed description
Ancillary procedures in patients of refractory facial palsy. Patients selection and evaluation of the outcomes.
Introduction:
There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821.
Virally triggered, acute FP, to which the term Bell's palsy (BP) refers, is one of the most common, and fortunately the most likely condition to result in eventual return to premorbid status; 70% to 90% of patients recover spontaneously. Other causes of FP routinely result in poorer recovery, and the clinician must discern among these to formulate a treatment plan.
In facial palsy, paralysis of muscles on the affected side of the face results in loss of forehead creases, loss of the nasolabial fold, lagophthalmos, brow droop, and drooping of the corner of the mouth. In contrast, muscles on the unaffected side of the face no longer have opposing forces.
This may cause difficulty in articulation, eating, drinking, and is often cosmetically unacceptable to patients because of asymmetry, especially when speaking, smiling, and laughing. There are significant psychological effects as patients lack the confidence to carry out many daily activities in public, such as appearing in photographs.
Although management is difficult, there are a range of reanimation options available. These include nerve grafts, muscle transfers, myofunctional approaches, and microsurgical patches usually for the more severe facial palsies (House-Brackmann grades 4 to 6). However, despite these procedures, facial symmetry may not improve.
Refractory Facial Palsy:
Facial paralysis is a rare disorder, but it has significant effects on an individual, both physical and emotional. While most patients fully recover from acute facial paralysis, a small population is left with chronic lingering symptoms. Refractory patients are those who had the maximum benefit of a performed procedure and need some fine touches and also those who did not recover well of the initial condition.
Aim of the Work:
This study is aimed to evaluate the outcome of ancillary procedures in refractory cases of facial palsy and to introduce both simple and sophisticated techniques to those patients presented to the investigator's department.
Inclusion Criteria:
Patients with refractory Facial Palsy who did not respond well to other concerned interferences and those who presented the maximum benefit possible of a performed procedure.
Patients \& Methods:
This study will be conducted on 20 patients attendance outpatient clinic of plastic surgery department - Assiut University Hospital.
Patients could be divided into three groups according to the anatomical site of interferences:
- Group 1: Upper third interferences
- Group 2: Mid third interferences
- Group 3: Lower third interferences Methodology
- Botulinum toxin A (BTXA) has been used since the 1970s to treat a variety of conditions resulting in abnormal muscle contraction or spasm. It works by preventing the release of acetylcholine into the neuromuscular junction thereby inhibiting muscle contraction.2 Its benefits in synkinesis in facial palsy (aberrant neural regeneration of the paralysed muscles) are well recognized.
BTXA was injected into the contralateral lower facial muscles complex to weaken the unopposed normal muscles to improve symmetry, both active and passive.
- Gold/Platinum weight implants Implantable devices have been used to restore dynamic lid closure in cases of severe, symptomatic lagophthalmos. These procedures are best for patients with poor Bell phenomenon and decreased corneal sensation. Gold or platinum weights, a weight-adjustable magnet, or palpebral springs can be inserted into the eyelids. Pretarsal gold-weight implantation is most commonly performed.
The implants are inert and composed of 99.99% pure gold or platinum. Sizes range from 0.6-1.8 g. The weight allows the upper eyelid to close with gravity when the levator palpebrae are relaxed. Therefore, patients must sleep with their head slightly elevated.
The implants are easily removed if nerve function returns. Complications include migration of the implant, inflammation, allergic reaction, and extrusion.
- Tarsorrhaphy Tarsorrhaphy decreases horizontal lid opening by fusing the eyelid margins together, increasing support of the precorneal lack of tears and improving coverage of the eye during sleep. The procedure can be done in the office and is particularly suitable for patients who are unable or unwilling to undergo other surgery.
Tarsorrhaphy can be performed laterally, centrally, or medially. The lateral procedure is the most common; however, it can restrict the monocular temporal visual field.
- Brow lifting Brow ptosis is repaired with a direct brow lift. Care should be taken in the presence of corneal decompensation because lifting the brow can cause worsening of lagophthalmos, especially if lid closure is poor. A gold-weight implant can be placed or lower-lid resuspension can be performed simultaneously to prevent this complication
- Suspension suture Static facial suspension procedures stabilise the muscles of mid-face paralysis and provide facial symmetry, a better aesthetic appearance, improved chewing and speech production in patients with facial paralysis. The new generation of Silhouette wires for tissue suspension is a significant improvement with respect to gold threads or Russian threads. They provide a new method of anchoring since they are made of polypropylene with absorbable cones of polylactic acid and glycolic acid. This suture allows tissue growth in and around the cones and therefore a strangerhood.
They were approved by the FDA in November 2006 and by the EEC in March 2007. They have been used in over 6,000 mid-face facial aesthetic surgery interventions in the U.S. and Europe and have recently begun to be used to treat facial paralysis.
- Fat injection Fat transfer to the face uses the patient's own adipose tissue (collected with a minor liposuction procedure from the belly or back), which gives volume and shape to the affected parts of the face, as well as impart glow and sheen to the skin
- Lateral Canthoplasty: canthoplasty may be considered as one of the most valuable oculoplastic surgical procedures to correct lid abnormalities. The indications include ectropion, entropion, lateral canthal dystopia, horizontal lid laxity, lid margin eversion.
Evaluation of outcome:
-Subjective:- 3 Plastic surgeon will be commenting on the pre and post photography regarding to normal side .
-Objective:- measurement between normal and effected side of the position eye brow ,Palpebral fissure, and angle of the mouth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients could be divided into three groups according to the anatomical site of interferences: * Group 1: Upper third interferences * Group 2: Mid third interferences * Group 3: Lower third interferences
| Arm | Type | Receives |
|---|---|---|
| Upper third interference | Experimental | Procedure: Botox and brow liftBotox \& brow lift |
| Middle third | Experimental | Procedure: InjectionBotox and fat injection |
| Lower third | Experimental | Procedure: SutureSuspension suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with refractory Facial Palsy who did not respond well to other concerned interferences and those who presented the maximum benefit possible of a performed procedure.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Botox and brow liftBotox injection | Procedure or surgery | Upper third interference |
| InjectionFat injection and botox | Procedure or surgery | Middle third |
| SutureSuspension suture | Procedure or surgery | Lower third |
Primary outcome
Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes
Time frame: 2 years
measurement the change in vertical length of the palpebral fissure of the affected eye before and after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No. Patients Selection and evaluation of the outcome.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox and brow lift, Injection and Suture in people with Facial Palsy, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 23 Jan 2020. 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 Egypt. 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.
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 Saleh Ali ElAzoumi, master (00201030842527, salehaljafari89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes (time frame: 2 years). 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 23 Jan 2020.