[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642033":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":50,"locations":54,"responsibleParty":56,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":54,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":54,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":84,"whyStopped":54,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":54},{"fullName":5,"class":6},"Peking University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Upper Depressor Anguli Oris Injection","EXPERIMENTAL","Single subcutaneous injection of OnabotulinumtoxinA (Botox®, Allergan, USA) into the upper half of the depressor anguli oris (DAO) muscle.\n\n* Drug preparation: 100U\u002Fvial reconstituted with 2mL sterile normal saline to a final concentration of 50U\u002FmL\n* Injection sites: 3 points per side: ① Inferolateral to the oral commissure (skin depression site during DAO contraction); ② Midpoint of the line from the oral commissure to the mandibular line along the DAO course; ③ Midpoint of the line connecting the first two points\n* Dosage: 1U (0.02mL) per point, total 6U bilaterally\n* Technique: 45° semi-recumbent position, 1mL syringe with 34G 1.5mm needle, vertical subcutaneous injection with needle bevel facing outward; gentle pressure with sterile cotton swab for 15-30 seconds post-injection; no massage allowed\n* Follow-up: 6 months after single injection",[13],"Drug: OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection)",{"label":15,"type":16,"description":17,"interventionNames":18},"Lower Depressor Anguli Oris Injection","ACTIVE_COMPARATOR","Single subcutaneous injection of OnabotulinumtoxinA (Botox®, Allergan, USA) into the lower half of the depressor anguli oris (DAO) muscle.\n\n* Drug preparation: Identical to the experimental group (100U\u002Fvial reconstituted to 50U\u002FmL)\n* Injection sites: 3 points per side forming a triangle: ① Midpoint between the oral commissure axis and the motor endplate; ② 0.5cm medial to the midpoint of the vertical line from the motor endplate to the mandibular margin; ③ 0.5cm lateral to the same midpoint\n* Dosage: 1U (0.02mL) per point, total 6U bilaterally\n* Technique: Identical to the experimental group (needle parameters, injection depth, post-injection instructions)\n* Follow-up: 6 months after single injection",[19],"Drug: OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","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.",[9],[27],"Botox®",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"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.",[15],[27],[34,38,41,44,47],{"name":35,"affiliation":36,"role":37},"Xi Gong, D.D.S","Peking University School and Hospital of Stomatology","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Minjie Chen, D.D.S","Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine",{"name":42,"affiliation":43,"role":37},"Jian Li, D.D.S","Wuhan University School of Stomatology",{"name":45,"affiliation":46,"role":37},"Yunpeng Li, D.D.S","School of Stomatology, Air Force Medical University",{"name":48,"affiliation":49,"role":37},"Sien Zhang, D.D.S","Guanghua School of Stomatology, Sun Yat-sen University",[51],{"name":35,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","+86 15201304426",null,"15201304426@163.com",{"type":57,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100642033","phase-4-botulinum-toxin-type-a-injection-sites-for-oral-commissure-ptosis-100642033",false,"NCT07646886","Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis","Injection Site-Based Multicenter Randomized Controlled Trial: Efficacy and Safety of Focal Botulinum Toxin Type A Injection for Oral Commissure Ptosis","Inclusion Criteria:\n\n* Aged 18 to 60 years, any gender\n* 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\n* Have clear aesthetic demand for oral commissure ptosis improvement and can complete full-cycle follow-up\n* No redness, swelling, ulcer, scar, deformity or active infection in the perioral and mental regions\n* Have not participated in other interventional clinical trials within 3 months before enrollment\n\nExclusion Criteria:\n\n* 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)\n* History of mid-lower facial botulinum toxin type A injection, soft tissue filling, laser\u002Fradiofrequency rejuvenation, perioral surgery or orthognathic treatment within 6 months before enrollment\n* Planned perioral treatment within 6 months after enrollment that may affect efficacy evaluation\n* Pregnant or lactating women, or those planning to become pregnant within 6 months\n* Acquired oral commissure ptosis caused by facial nerve palsy\u002Fsequelae, perioral scar traction, severe jaw deformity or severe alveolar bone resorption\n* Severe facial asymmetry (difference in bilateral oral commissure ptosis angle \\> 2°)\n* History of botulinum toxin allergy or severe adverse reactions after previous botulinum toxin injection\n* 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\n* History of mental illness, drug\u002Falcohol abuse, or poor compliance unable to complete follow-up\n* Other conditions deemed unsuitable for enrollment by the investigator","ALL","18 Years","60 Years",{"count":69,"type":70},266,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","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.",[76,77,78],"Facial Aging","Melomental Folds","Oral Commissure Ptosis",[80,78,77,81,82,83],"Botulinum Toxin Type A","Depressor Anguli Oris Muscle","Randomized Controlled Trial","Injection Site","NOT_YET_RECRUITING","2026-06-11",{"date":87,"type":88},"2026-06-15","ACTUAL",{"date":90,"type":70},"2026-07-01",{"date":92,"type":70},"2027-12-01",{"name":5,"class":6}]