The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective assessment
研究概览
简要总结
The purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consecutive 30 female patients presenting to our clinic for brow lifting with botulinum toxin will be randomized to receive one of the two injection techniques
排除标准
- •Patients with previous periorbital/forehead surgery
- •Patients who plucked the upper eyebrow margin
- •Patients with eyebrow tatoos
- •Patients with upper face botulinum toxin injection in the past 12 months
- •Patients with resorbable upper face fillers injection in the past 12 months
- •Patients with previous permanent upper 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
Technique 1: Lateral orbicularis injections
5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim.
干预措施: Dysport (Drug)
Technique 1: Lateral orbicularis injections
5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim.
干预措施: lateral orbicularis injection (Procedure)
2. Technique 2: Lateral orbicularis and Corrugator injections
5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. In addition, 2 injections will be placed into the corrugator at the medial brow
干预措施: Dysport (Drug)
2. Technique 2: Lateral orbicularis and Corrugator injections
5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. In addition, 2 injections will be placed into the corrugator at the medial brow
干预措施: Lateral orbicularis + corrugator injection (Procedure)
结局指标
主要结局
Objective assessment
时间窗: 15 days post treatment
Objective assessment will be done on anteroposterior views of pre-and-post injection photographs. The mid pupillary line will be drawn and the eyebrow vertical height will be measured from this line to the upper border of the brow at seven horizontal points: the most medial aspect of the eyebrow, medial canthus, medial limbus, mid pupil, lateral limbus, lateral sclera, and most lateral eyebrow.
次要结局
- Patient satisfaction(15 days post treatment)
研究者
samer jabbour
MD
St Joseph University, Beirut, Lebanon