Botulinum Toxin, Rejuvenation, Neck, Therapy
Conditions
Brief summary
The purpose of this study is to describe a safe and consistent technique for neck rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the intervention and determine the patients that would benefit most.
Detailed description
The abobotulinumtoxinA will be used for the Nefertiti lift The abobotulinumtoxinA will be prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction) Injection points: * A series of 4 injection points 1-2 cm apart on a horizontal line under the mandible posterior to the hypothetical line were the nasolabial fold meets the mandible * If present, injection of each platysmal band every 2 cm with 2 to 4 injection points per band (Injection of platysmal band will be done by holding the band between 2 fingers and injecting intramuscularly) For all injection points 5 units per point of abobotulinumtoxinA will be used A maximum of 125 units of abobotulinumtoxinA will be allowed for the global neck treatment Follow up will be done at 15 days for retouching or for post op pictures if no retouching is needed. if retouching is needed post injection pictures will be taken 10 days post retouching Retouching: each residual platysmal band will be reinjected every 2 cm with 2 to 4 injection points per band (Injection of platysmal band will be done by holding the band between 2 fingers and injecting intramuscularly) (5 units per point of abobotulinumtoxinA will be used) A total of 30 patients will be recruited
Interventions
PROCEDURENefertiti lift
Sponsors
St Joseph University, Beirut, Lebanon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mandibular definition change with maximal contraction will be assessed by a 2-point scale | 15-25 days post treatment | The assessment of the pre-injection photos will be done by 2 plastic surgeons and 1 dermatologist Mandibular contour does not worsen with platysmal contraction Mandibular contour worsen with platysmal contraction |
| Neck volume using a validated scale from the Summit Scale II (1) | 15-25 days post treatment | The assessment will be done by 2 plastic surgeons and 1 dermatologist. 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 |
| Jowls at rest using a validated scale from the Summit Scale II (2) | 15-25 days post treatment | The assessment will be done by 2 plastic surgeons and 1 dermatologist. 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 |
| Marionette lines at rest using a validated scale from the Summit Scale II (3) | 15-25 days post treatment | The assessment will be done by 2 plastic surgeons and 1 dermatologist. 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 |
| Oral commissures at rest using a validated scale from the Summit Scale II (2) | 15-25 days post treatment | The assessment will be done by 2 plastic surgeons and 1 dermatologist. 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 |
| Platysmal bands at maximal contraction using a validated scale (4) | 15-25 days post treatment | The assessment will be done by 2 plastic surgeons and 1 dermatologist. 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 |
| Platysmal bands at rest using a validated scale (5) | 15-25 days post treatment | The assessment will be done by 2 plastic surgeons and 1 dermatologist. 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Global Aesthetic Improvement Scale | 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 |
| Patient satisfaction | 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. |
| Patient willingness to repeat the procedure | 15-25 days post treatment | Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response |
| Patient willingness to recommend the procedure | 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 |
| Assessment of Pain during treatment | At the day of the procedure | 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 |
| Investigators Global Aesthetic Improvement Scale | 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 |
Countries
Lebanon
Outcome results
None listed