Microbotox for Lower Face Rejuvenation

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Botulinum Toxin, Rejuvenation, Therapy, Neck

Intervention / Treatment
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* Procedure: Microbotox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Procedure: Microbotox<br>* Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. No Sagging Mild Sagging Moderate Sagging Severe Sagging Very Severe Sagging | 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 No Sagging Mild Sagging Moderate Sagging Severe Sagging Very Severe Sagging | 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 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 | 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 No Downturn Mild Downturn Moderate Downturn Severe Downturn Very Severe Downturn | 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 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 | 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. 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 | 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. Mandibular contour does not worsen with platysmal contraction Mandibular contour worsen with platysmal contraction | 15-25 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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 | 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: 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 | 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: Very Satisfied Satisfied Dissatisfied Very Dissatisfied. | 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 | 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 | 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 | Immediately after the treatment |