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Completed

NCT Number: NCT03189082

Microbotox for Lower Face Rejuvenation

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.

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Key information

Conditions

Botulinum Toxin Neck Rejuvenation Therapy

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbotox

Procedure

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

Primary outcomes

  1. 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.

    • No Sagging
    • Mild Sagging
    • Moderate Sagging
    • Severe Sagging
    • Very Severe Sagging

  2. 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

    • No Sagging
    • Mild Sagging
    • Moderate Sagging
    • Severe Sagging
    • Very Severe Sagging

  3. 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

    • No visible folds: continuous skin lines
    • Shallow but visible folds with slight indentation
    • Moderately deep folds, clear feature at normal appearance, but not when stretched
    • Very long and deep folds, prominent facial feature
    • Extremely long and deep folds; detrimental facial appearance

  4. 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

    • No Downturn
    • Mild Downturn
    • Moderate Downturn
    • Severe Downturn
    • Very Severe Downturn

  5. 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

    • No relevant prominence of platysmal bands
    • Mild prominence of platysmal bands
    • Moderate prominence of platysmal bands
    • Severe prominence of platysmal bands
    • Very severe prominence of platysmal bands

  6. 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.

    • No platsymal bands visible at rest
    • Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck.
    • Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue.
    • Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue.
    • 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

  7. 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.

    • Mandibular contour does not worsen with platysmal contraction
    • Mandibular contour worsen with platysmal contraction

Secondary outcomes

  1. 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:

    • Very Much Improved: optimal cosmetic results
    • Much Improved: marked improvement in appearance from initial condition but not completely optimal
    • Improved: obvious improvement in appearance from initial condition but additional treatments are advised
    • No Change: the appearance is the same as the original condition
    • Worse: the appearance is worse from the original condition

  2. 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:

    • Very Much Improved: optimal cosmetic results
    • Much Improved: marked improvement in appearance from initial condition but not completely optimal
    • Improved: obvious improvement in appearance from initial condition but additional treatments are advised
    • No Change: the appearance is the same as the original condition
    • Worse: the appearance is worse from the original condition

  3. 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:

    • Very Satisfied
    • Satisfied
    • Dissatisfied
    • Very Dissatisfied.

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2017
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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