Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis

Официальное название

Injection Site-Based Multicenter Randomized Controlled Trial: Efficacy and Safety of Focal Botulinum Toxin Type A Injection for Oral Commissure Ptosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection)
  Single subcutaneous injection of onabotulinumtoxinA into the upper half of the depressor anguli oris muscle, total dose 6U bilaterally.
• Препарат OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)
  Single subcutaneous injection of onabotulinumtoxinA into the lower half of the depressor anguli oris muscle, total dose 6U bilaterally.

Первичные конечные точки

• Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment [Срок оценки: 30±3 days after treatment]

Вторичные конечные точки (9)

• Improvement of Oral Commissure Ptosis Angle at Maximum Smile and Maximum Depression Position [Срок оценки: 1, 3, 6 months after treatment]
• Vertical Elevation Amplitude of the Oral Commissure [Срок оценки: 1, 3, 6 months after treatment]
• Merz Facial Aesthetic Scale Score [Срок оценки: 1, 3, 6 months after treatment]
• Global Aesthetic Improvement Scale (GAIS) [Срок оценки: 1, 3, 6 months after treatment]
• Patient Satisfaction Score (FACE-Q) [Срок оценки: 1, 3, 6 months after treatment]
• Incidence of Adverse Events (AEs) [Срок оценки: From enrollment to 6 months after treatment]
• Incidence of Toxin Diffusion-Related Adverse Events [Срок оценки: From enrollment to 6 months after treatment]
• Incidence of Serious Adverse Events (SAEs) [Срок оценки: From enrollment to 6 months after treatment]
• Patient Satisfaction Score (Visual Analog Scale, VAS) [Срок оценки: 1, 3, 6 months after treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07646886 · PekingUDAO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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