Injection Site-Based Multicenter Randomized Controlled Trial: Efficacy and Safety of Focal Botulinum Toxin Type A Injection for Oral Commissure Ptosis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 266
- 主要终点
- Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment
研究概览
简要总结
This multicenter, prospective, randomized parallel-controlled, assessor-blinded clinical trial aims to address the core clinical pain point of lack of high-level evidence and non-standardized operation in injection site selection for BTX-A treatment of oral commissure ptosis. A total of 266 eligible subjects will be randomly assigned in a 1:1 ratio to receive either upper DAO or lower DAO BTX-A injection. The study will compare the clinical efficacy, time-effect characteristics and safety profiles of the two regimens, and conduct stratified analysis of treatment response in different patient subtypes. The results will determine the optimal injection site for Chinese population, establish standardized operation specifications, fill the international evidence gap, and provide level I evidence for clinical practice.
详细描述
Oral commissure ptosis is a common aesthetic concern that presents as abnormal downward displacement of the mouth corners at rest, leading to a sad, angry or aged appearance. Botulinum toxin type A (BTX-A) injection is the first-line treatment, but there is no consensus on the optimal injection site in the depressor anguli oris (DAO) muscle.
This multicenter randomized controlled trial will enroll 266 subjects with oral commissure ptosis from 5 top Chinese stomatological hospitals. Subjects will be randomly assigned 1:1 to receive either upper DAO or lower DAO BTX-A injection. The primary endpoint is the improvement of oral commissure ptosis angle at 1 month post-treatment. Secondary endpoints include objective efficacy measures, subjective aesthetic evaluations, and safety profiles during a 6-month follow-up.
This study aims to determine the optimal injection site for Chinese population, establish standardized operation specifications, and provide level I evidence for clinical practice.
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
- Single (Outcomes Assessor)
盲法说明
Single-blinded design for outcomes assessors only. All facial photographs and measurement data are anonymized with all group and time point information removed. Injecting physicians do not participate in any efficacy assessment. All outcomes are evaluated by 3 independent third-party assessors who are completely blinded to the group assignment. Subjects are informed that the study compares two different injection techniques but are not told their specific group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 60 years, any gender
- •Meet the diagnostic criteria for oral commissure ptosis: bilateral oral commissure ptosis angle (angle between the oral commissure point and the horizontal line of the ipsilateral vermilion border) > 1° at rest
- •Have clear aesthetic demand for oral commissure ptosis improvement and can complete full-cycle follow-up
- •No redness, swelling, ulcer, scar, deformity or active infection in the perioral and mental regions
- •Have not participated in other interventional clinical trials within 3 months before enrollment
排除标准
- •Hypersensitivity to botulinum toxin type A, lidocaine or excipients of injection preparations; or contraindications to botulinum toxin injection (myasthenia gravis, Lambert-Eaton syndrome, motor neuron disease, severe liver and kidney dysfunction, coagulation disorders, uncontrolled autoimmune diseases, malignant tumors)
- •History of mid-lower facial botulinum toxin type A injection, soft tissue filling, laser/radiofrequency rejuvenation, perioral surgery or orthognathic treatment within 6 months before enrollment
- •Planned perioral treatment within 6 months after enrollment that may affect efficacy evaluation
- •Pregnant or lactating women, or those planning to become pregnant within 6 months
- •Acquired oral commissure ptosis caused by facial nerve palsy/sequelae, perioral scar traction, severe jaw deformity or severe alveolar bone resorption
- •Severe facial asymmetry (difference in bilateral oral commissure ptosis angle > 2°)
- •History of botulinum toxin allergy or severe adverse reactions after previous botulinum toxin injection
- •Currently using aminoglycoside antibiotics, quinine, calcium channel blockers, anticoagulants or other drugs that may affect botulinum toxin efficacy or increase bleeding risk and cannot discontinue
- •History of mental illness, drug/alcohol abuse, or poor compliance unable to complete follow-up
- •Other conditions deemed unsuitable for enrollment by the investigator
结局指标
主要结局
Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment
时间窗: 30±3 days after treatment
The primary endpoint is the change in bilateral oral commissure ptosis angle (∠oba) from baseline. The angle is measured on standardized frontal facial photographs at rest by 3 independent assessors who are completely blinded to group assignment. The average value of 3 measurements is used as the final result.
次要结局
- Improvement of Oral Commissure Ptosis Angle at Maximum Smile and Maximum Depression Position(1, 3, 6 months after treatment)
- Vertical Elevation Amplitude of the Oral Commissure(1, 3, 6 months after treatment)
- Merz Facial Aesthetic Scale Score(1, 3, 6 months after treatment)
- Global Aesthetic Improvement Scale (GAIS)(1, 3, 6 months after treatment)
- Patient Satisfaction Score (FACE-Q)(1, 3, 6 months after treatment)
- Incidence of Adverse Events (AEs)(From enrollment to 6 months after treatment)
- Incidence of Toxin Diffusion-Related Adverse Events(From enrollment to 6 months after treatment)
- Incidence of Serious Adverse Events (SAEs)(From enrollment to 6 months after treatment)
- Patient Satisfaction Score (Visual Analog Scale, VAS)(1, 3, 6 months after treatment)