"Microbotox" Versus Intramuscular Botulinum Toxin in Lower Face Rejuvenation: A Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Neck volume using a validated scale from the Summit Scale II
研究概览
简要总结
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.
详细描述
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.
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
研究组 & 干预措施
Intervention group
干预措施: Microbotox (Procedure)
结局指标
主要结局
Neck volume using a validated scale from the Summit Scale II
时间窗: 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. 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging
Jowls at rest using a validated scale from the Summit Scale II
时间窗: 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 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging
Marionette lines at rest using a validated scale from the Summit Scale II
时间窗: 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 1. No visible folds: continuous skin lines 2. Shallow but visible folds with slight indentation 3. Moderately deep folds, clear feature at normal appearance, but not when stretched 4. Very long and deep folds, prominent facial feature 5. Extremely long and deep folds; detrimental facial appearance
Oral commissures at rest using a validated scale from the Summit Scale II
时间窗: 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 1. No Downturn 2. Mild Downturn 3. Moderate Downturn 4. Severe Downturn 5. Very Severe Downturn
Platysmal bands at maximal contraction using a validated scale
时间窗: 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 1. No relevant prominence of platysmal bands 2. Mild prominence of platysmal bands 3. Moderate prominence of platysmal bands 4. Severe prominence of platysmal bands 5. Very severe prominence of platysmal bands
Platysmal bands at rest using a validated scale
时间窗: 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. 1. No platsymal bands visible at rest 2. Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck. 3. Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue. 4. Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue. 5. 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
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 3 plastic surgeons. 1. Mandibular contour does not worsen with platysmal contraction 2. Mandibular contour worsen with platysmal contraction
次要结局
- Investigators Global Aesthetic Improvement Scale(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)
- Patient willingness to recommend the procedure(15-25 days post treatment)
- Assessment of Pain during treatment(Immediately after the treatment)
研究者
samer jabbour
M.D.
St Joseph University, Beirut, Lebanon