Nefertiti Lift for Neck Rejuvenation: Assessing Efficiency and Re-defining Patient Selection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Platysmal bands at rest using a validated scale (5)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Platysmal bands at rest using a validated scale (5)
时间窗: 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
Oral commissures at rest using a validated scale from the Summit Scale II (2)
时间窗: 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
Neck volume using a validated scale from the Summit Scale II (1)
时间窗: 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
Mandibular definition change with maximal contraction will be assessed by a 2-point scale
时间窗: 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
Jowls at rest using a validated scale from the Summit Scale II (2)
时间窗: 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)
时间窗: 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
Platysmal bands at maximal contraction using a validated scale (4)
时间窗: 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
次要结局
- Investigators Global Aesthetic Improvement Scale(15-25 days post treatment)
- Patient willingness to recommend the procedure(15-25 days post treatment)
- Subject Global Aesthetic Improvement Scale(15-25 days post treatment)
- Patient satisfaction(15-25 days post treatment)
- Patient willingness to repeat the procedure(15-25 days post treatment)
- Assessment of Pain during treatment(At the day of the procedure)
研究者
samer jabbour
M.D.
St Joseph University, Beirut, Lebanon