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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Saleh Ali ElAzoumi, master contact

00201030842527

salehaljafari89@gmail.com

Ahmed Mohammed Tohamy, master contact

+201221783834

ahmedtohamy92@gmail.com

Egypt1 site, 1 recruiting
  • Assuit university

    Asyut, Assuit, 71515

    Mohamed Alshazly Alshazly, Professor, +20100666795, Eshazly@aun.edu.eg

    Ahmed Tohamy Tohamy, Doctor, +201221783834, ahmedtohamy92@gmail.com

    Recruiting

Other trials in Egypt

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 groups in NCT04237961
Study groupRoleWhat they receive
Upper third interferenceExperimentalBotox \& brow lift
Receives: Procedure: Botox and brow lift
Middle thirdExperimentalBotox and fat injection
Receives: Procedure: Injection
Lower thirdExperimentalSuspension suture
Receives: Procedure: Suture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted23 Jan 2020
  2. Study start1 Jan 2019
  3. Primary completion28 Jan 2020 (estimated)
  4. Study completion28 Mar 2020 (estimated)

Resources

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)
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.

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.

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