Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPeking University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection)
- OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)
Treatment groups
266 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov