Microbotox for Lower Face Rejuvenation

October 5, 2017 updated by: samer jabbour, St Joseph University, Beirut, Lebanon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
    • Aschrafieh
      • Beirut, Aschrafieh, Lebanon, 00961
        • Hotel Dieu de France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Procedure: Microbotox
Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
15-25 days post treatment
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
15-25 days post treatment
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
15-25 days post treatment
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
15-25 days post treatment
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
15-25 days post treatment
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
15-25 days post treatment
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
15-25 days post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigators Global Aesthetic Improvement Scale
Time Frame: 15-25 days post treatment

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
15-25 days post treatment
Subject Global Aesthetic Improvement Scale
Time Frame: 15-25 days post treatment

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
15-25 days post treatment
Patient satisfaction
Time Frame: 15-25 days post treatment

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.
15-25 days post treatment
Patient willingness to repeat the procedure
Time Frame: 15-25 days post treatment
Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response
15-25 days post treatment
Patient willingness to recommend the procedure
Time Frame: 15-25 days post treatment
Patient willingness to recommend the procedure to a friend will be assessed by a simple question with a Yes or No response
15-25 days post treatment
Assessment of Pain during treatment
Time Frame: Immediately after the 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
Immediately after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St Joseph University, Beirut, Lebanon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USJ-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Therapy

Clinical Trials on Microbotox

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings