Botulinum ToxinNCT03189082

Microbotox for Lower Face Rejuvenation

A study testing Microbotox in people with Botulinum Toxin and Rejuvenation, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficiency of the intradermal injection of botulinum toxin in lower face rejuvenation. The study will also compare this intervention with the "Nefertiti Lift" intramuscular injection technique. Read more about this study

Who is it for?: Ages 18 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for: Botulinum Toxin, Rejuvenation, Therapy
What is being tested?: Microbotox
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteLebanon
Study dates: 10 Aug 2017to 4 Oct 2017
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 18 to 90 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female patients presenting to our clinic for neck rejuvenation who:
Were deemed nonsurgical candidates for neck rejuvenation
Were not willing to undergo invasive surgical procedures
Had a medical contraindication to surgery

Who cannot join

Patients with lower face botulinum toxin injection in the past 12 months
Patients with resorbable lower face fillers injection in the past 12 months
Patients with previous permanent lower face fillers injection
Pregnant patients
Lactating patients
Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
Patients with sensitivity to botulinum toxin or human albumin

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

Hotel Dieu De France
Beirut, Aschrafieh, 00961

Other trials in Lebanon

About this study

Official title: "Microbotox" Versus Intramuscular Botulinum Toxin in Lower Face Rejuvenation: A Crossover Clinical Trial

Read the detailed description

The abobotulinumtoxinA will be used for the intervention. The abobotulinumtoxinA will be prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial. Further dilution to the appropriate Microbotox concentration will be done in the syringe itself. Each 1mL syringe of Microbotox solution will contain 20-28 units of onabotulinumtoxinA per mL of solution.

Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction)

Injection points:

A series of 100-150 intradermal microdroplets injection points 1 cm apart will be delivered in the lower face. The area to be injected is bounded by a line 3 fingerbreadths above and parallel to the lower border of the mandible, 1 fingerbreadth posterior to the depressor anguli oris, and all the way down over the cervicomental angle and anterior neck to the upper border of the clavicle, and posteriorly to the anterior border of the sternocleidomastoid.

In the average patient, 2 syringes of 28 units per mL of microbotox will be used to cover the entire area.

In heavier necks, 3 syringes of 28 units per mL will be used. In thinner necks, 2 syringes of 20 units per mL will be used.

Follow up will be done at 15 days for post injection pictures. A total of 15 patients will be recruited

Conditions: Botulinum Toxin, Rejuvenation, Therapy, Neck
Being tested: Microbotox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MicrobotoxProcedure or surgery
Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face

Study groups in NCT03189082
Study group	Role	What they receive
Intervention group	Experimental	Not described Receives: Procedure: Microbotox

What is being measured

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

Neck volume using a validated scale from the Summit Scale II
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos.
1. No Sagging
2. Mild Sagging
3. Moderate Sagging
4. Severe Sagging
5. Very Severe Sagging
Measured: 15-25 days post treatment
Jowls at rest using a validated scale from the Summit Scale II
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos
1. No Sagging
2. Mild Sagging
3. Moderate Sagging
4. Severe Sagging
5. Very Severe Sagging
Measured: 15-25 days post treatment
Marionette lines at rest using a validated scale from the Summit Scale II
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos
1. No visible folds: continuous skin lines
2. Shallow but visible folds with slight indentation
3. Moderately deep folds, clear feature at normal appearance, but not when stretched
4. Very long and deep folds, prominent facial feature
5. Extremely long and deep folds; detrimental facial appearance
Measured: 15-25 days post treatment
Oral commissures at rest using a validated scale from the Summit Scale II
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos
1. No Downturn
2. Mild Downturn
3. Moderate Downturn
4. Severe Downturn
5. Very Severe Downturn
Measured: 15-25 days post treatment
Platysmal bands at maximal contraction using a validated scale
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos
1. No relevant prominence of platysmal bands
2. Mild prominence of platysmal bands
3. Moderate prominence of platysmal bands
4. Severe prominence of platysmal bands
5. Very severe prominence of platysmal bands
Measured: 15-25 days post treatment
Platysmal bands at rest using a validated scale
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale.
1. No platsymal bands visible at rest
2. Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck.
3. Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue.
4. Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue.
5. Severe platsymal bands along the full length of the neck at rest, elevation at least 5 mm from the surrounding tissue, with additional soft tissue ptotic banding present laterally
Measured: 15-25 days post treatment
Mandibular definition change with maximal contraction will be assessed by a 2-point scale
The assessment of the pre-injection photos will be done by 3 plastic surgeons.
1. Mandibular contour does not worsen with platysmal contraction
2. Mandibular contour worsen with platysmal contraction
Measured: 15-25 days post treatment

Secondary outcomes (6)

Investigators Global Aesthetic Improvement Scale
Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the investigators using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows:
1. Very Much Improved: optimal cosmetic results
2. Much Improved: marked improvement in appearance from initial condition but not completely optimal
3. Improved: obvious improvement in appearance from initial condition but additional treatments are advised
4. No Change: the appearance is the same as the original condition
5. Worse: the appearance is worse from the original condition
Measured: 15-25 days post treatment
Subject Global Aesthetic Improvement Scale
Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the subject using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on a live assessment of the subject with a mirror in hand for real time assessment and and a photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows:
1. Very Much Improved: optimal cosmetic results
2. Much Improved: marked improvement in appearance from initial condition but not completely optimal
3. Improved: obvious improvement in appearance from initial condition but additional treatments are advised
4. No Change: the appearance is the same as the original condition
5. Worse: the appearance is worse from the original condition
Measured: 15-25 days post treatment
Patient satisfaction
Patient satisfaction will be determined by a questionnaire completed at 15-25 days post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow:
1. Very Satisfied
2. Satisfied
3. Dissatisfied
4. Very Dissatisfied.
Measured: 15-25 days post treatment
Patient willingness to repeat the procedure
Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response
Measured: 15-25 days post treatment
Patient willingness to recommend the procedure
Patient willingness to recommend the procedure to a friend will be assessed by a simple question with a Yes or No response
Measured: 15-25 days post treatment
Assessment of Pain during treatment
Subjects' pain during the treatment will be recorded using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible
Measured: Immediately after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20174 Oct 2017

First posted16 Jun 2017
Study start10 Aug 2017
Primary completion10 Sep 2017
Study completion4 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Botulinum ToxinStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03189082
Sponsor's protocol ID: USJ-04
Status last verified: Oct 2017
First submitted: 9 Jun 2017
Last updated: 6 Oct 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Awaida CJ, Jabbour SF, Rayess YA, El Khoury JS, Kechichian EG, Nasr MW. Evaluation of the Microbotox Technique: An Algorithmic Approach for Lower Face and Neck Rejuvenation and a Crossover Clinical Trial. Plast Reconstr Surg. 2018 Sep;142(3):640-649. doi: 10.1097/PRS.0000000000004695.
PubMed 29879010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Botulinum Toxin trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Microbotox" Versus Intramuscular Botulinum Toxin in Lower Face Rejuvenation: A Crossover Clinical Trial
ClinicalTrials.gov ID: NCT03189082
Acronym / sponsor ID: USJ-04
Conditions: Botulinum Toxin, Rejuvenation, Therapy, Neck
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: St Joseph University, Beirut, LebanonUniversity, hospital or other
Study start: 10 Aug 2017 (actual)
Primary completion: 10 Sep 2017 (actual)
Study completion: 4 Oct 2017 (actual)
First posted: 16 Jun 2017 (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.

Detailed description

Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction)

Injection points:

In the average patient, 2 syringes of 28 units per mL of microbotox will be used to cover the entire area.

In heavier necks, 3 syringes of 28 units per mL will be used. In thinner necks, 2 syringes of 20 units per mL will be used.

Follow up will be done at 15 days for post injection pictures. A total of 15 patients will be recruited

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention group	Experimental	Procedure: Microbotox

Who may qualify

Ages: 18 to 90 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Were deemed nonsurgical candidates for neck rejuvenation
Were not willing to undergo invasive surgical procedures
Had a medical contraindication to surgery

Key exclusion criteria (8 listed)

Patients with lower face botulinum toxin injection in the past 12 months
Patients with resorbable lower face fillers injection in the past 12 months
Patients with previous permanent lower face fillers injection
Pregnant patients
Lactating patients

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
MicrobotoxMicrobotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face	Procedure or surgery	Intervention group

Primary outcome

Neck volume using a validated scale from the Summit Scale II
Time frame: 15-25 days post treatment
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos. 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging
Jowls at rest using a validated scale from the Summit Scale II
Time frame: 15-25 days post treatment
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging
Marionette lines at rest using a validated scale from the Summit Scale II
Time frame: 15-25 days post treatment
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No visible folds: continuous skin lines 2. Shallow but visible folds with slight indentation 3. Moderately deep folds, clear feature at normal appearance, but not when stretched 4. Very long and deep folds, prominent facial feature 5. Extremely long and deep folds; detrimental facial appearance
Oral commissures at rest using a validated scale from the Summit Scale II
Time frame: 15-25 days post treatment
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No Downturn 2. Mild Downturn 3. Moderate Downturn 4. Severe Downturn 5. Very Severe Downturn
Platysmal bands at maximal contraction using a validated scale
Time frame: 15-25 days post treatment
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No relevant prominence of platysmal bands 2. Mild prominence of platysmal bands 3. Moderate prominence of platysmal bands 4. Severe prominence of platysmal bands 5. Very severe prominence of platysmal bands
Platysmal bands at rest using a validated scale
Time frame: 15-25 days post treatment
The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. 1. No platsymal bands visible at rest 2. Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck. 3. Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue. 4. Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue. 5. Severe platsymal bands along the full length of the neck at rest, elevation at least 5 mm from the surrounding tissue, with additional soft tissue ptotic banding present laterally
Mandibular definition change with maximal contraction will be assessed by a 2-point scale
Time frame: 15-25 days post treatment
The assessment of the pre-injection photos will be done by 3 plastic surgeons. 1. Mandibular contour does not worsen with platysmal contraction 2. Mandibular contour worsen with platysmal contraction

6 secondary outcomes

Investigators Global Aesthetic Improvement Scale
Time frame: 15-25 days post treatment
Subject Global Aesthetic Improvement Scale
Time frame: 15-25 days post treatment
Patient satisfaction
Time frame: 15-25 days post treatment
Patient willingness to repeat the procedure
Time frame: 15-25 days post treatment
Patient willingness to recommend the procedure
Time frame: 15-25 days post treatment
Assessment of Pain during treatment
Time frame: Immediately after the treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
Derived from this study: PubMed 29879010Awaida CJ, Jabbour SF, Rayess YA, El Khoury JS, Kechichian EG, Nasr MW. Evaluation of the Microbotox Technique: An Algorithmic Approach for Lower Face and Neck Rejuvenation and a Crossover Clinical Trial. Plast Reconstr Surg. 2018 Sep;142(3):640-649. doi: 10.1097/PRS.0000000000004695.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Microbotox in people with Botulinum Toxin and Rejuvenation, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.

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 4 inclusion and 8 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: finished, as of the sponsor's last update on 6 Oct 2017. 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 Lebanon. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck volume using a validated scale from the Summit Scale II (time frame: 15-25 days post treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03189082, which also lists 1 linked publication.

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 6 Oct 2017.