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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection)
DrugSingle subcutaneous injection of onabotulinumtoxinA into the upper half of the depressor anguli oris muscle, total dose 6U bilaterally.
OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)
DrugSingle subcutaneous injection of onabotulinumtoxinA into the lower half of the depressor anguli oris muscle, total dose 6U bilaterally.
Treatment groups
266 Participants
are divided into 2 treatment groupsGroup A: Upper Depressor Anguli Oris InjectionExperimental treatment 1 intervention
Group B: Lower Depressor Anguli Oris InjectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-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.
Time frame
30±3 days after treatmentSecondary outcomes
1
Improvement of Oral Commissure Ptosis Angle at Maximum Smile and Maximum Depression Position
Change in oral commissure ptosis angle from baseline measured at maximum smile without teeth exposure and maximum oral commissure depression position on standardized facial photographs.
Time frame
1, 3, 6 months after treatment2
Vertical Elevation Amplitude of the Oral Commissure
Change in the vertical distance from the oral commissure point to the ipsilateral pupil from baseline, measured on standardized frontal facial photographs.
Time frame
1, 3, 6 months after treatment3
Merz Facial Aesthetic Scale Score
Physician-assessed aesthetic improvement using the full Merz Facial Aesthetic Scale. Scale range: 0 (No aging) to 4 (Severe aging). Lower scores indicate better aesthetic outcome.
Time frame
1, 3, 6 months after treatment4
Global Aesthetic Improvement Scale (GAIS)
Patient-reported global aesthetic improvement using the full Global Aesthetic Improvement Scale (GAIS). Scale range: 1 (Much worse) to 5 (Much improved). Higher scores indicate better aesthetic outcome.
Time frame
1, 3, 6 months after treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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