Not Yet RecruitingPhase 4

Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis

266 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 bila…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing different injection sites for Botulinum Toxin Type A to lift drooping mouth corners — how does my doctor currently approach this treatment in their own practice, and would joining this study change anything about how I'd be treated?
2Since this trial is Phase 4, meaning the medication itself is already FDA-approved, what specifically is still being studied here — is it the injection location technique that's being compared, and how might that affect my results compared to the standard approach?
3The trial hasn't started recruiting yet — how long might it be before it opens, and is it worth waiting for it or are there established treatments for oral commissure ptosis I could pursue right now?
4The main outcome is measured at just one month after treatment — does my doctor think that's enough time to judge whether the results are meaningful for me, and what happens to my care after that one-month follow-up?
5Given that melomental folds and drooping mouth corners can be addressed through several different approaches like fillers, surgery, or other injectables, how does my doctor think this Botulinum Toxin injection-site study compares to those alternatives for someone in my specific situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment

Timeframe: 30±3 days after treatment

Trial details

NCT IDNCT07646886

SponsorPeking University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Xi Gong, D.D.S

+86 15201304426 15201304426@163.com

View on ClinicalTrials.gov More Facial Aging trials