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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbotox | Procedure | Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face |
|
| 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.
| 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
| 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
| 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
| 15-25 days post treatment |
| 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:
|
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Inclusion Criteria:
Female patients presenting to our clinic for neck rejuvenation who:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu De France | Beirut | Aschrafieh | 00961 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29879010 | Derived | 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. |
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| 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
| 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.
| 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.
| 15-25 days post treatment |
| 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:
| 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:
| 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 |