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Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis

3 luglio 2026 aggiornato da: Peking University

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

266

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Upper Depressor Anguli Oris Injection

Single subcutaneous injection of OnabotulinumtoxinA (Botox®, Allergan, USA) into the upper half of the depressor anguli oris (DAO) muscle.

  • Drug preparation: 100U/vial reconstituted with 2mL sterile normal saline to a final concentration of 50U/mL
  • 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
  • Dosage: 1U (0.02mL) per point, total 6U bilaterally
  • 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
  • Follow-up: 6 months after single injection
Droga: 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.
Altri nomi:
  • Botox®
Comparatore attivo: Lower Depressor Anguli Oris Injection

Single subcutaneous injection of OnabotulinumtoxinA (Botox®, Allergan, USA) into the lower half of the depressor anguli oris (DAO) muscle.

  • Drug preparation: Identical to the experimental group (100U/vial reconstituted to 50U/mL)
  • 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
  • Dosage: 1U (0.02mL) per point, total 6U bilaterally
  • Technique: Identical to the experimental group (needle parameters, injection depth, post-injection instructions)
  • Follow-up: 6 months after single injection
Droga: 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.
Altri nomi:
  • Botox®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment
Lasso di tempo: 30±3 days after 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.
30±3 days after treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Improvement of Oral Commissure Ptosis Angle at Maximum Smile and Maximum Depression Position
Lasso di tempo: 1, 3, 6 months after treatment
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.
1, 3, 6 months after treatment
Vertical Elevation Amplitude of the Oral Commissure
Lasso di tempo: 1, 3, 6 months after treatment
Change in the vertical distance from the oral commissure point to the ipsilateral pupil from baseline, measured on standardized frontal facial photographs.
1, 3, 6 months after treatment
Merz Facial Aesthetic Scale Score
Lasso di tempo: 1, 3, 6 months after treatment
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.
1, 3, 6 months after treatment
Global Aesthetic Improvement Scale (GAIS)
Lasso di tempo: 1, 3, 6 months after treatment
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.
1, 3, 6 months after treatment
Patient Satisfaction Score (FACE-Q)
Lasso di tempo: 1, 3, 6 months after treatment
Patient-reported facial appearance satisfaction using the full FACE-Q Facial Appearance Module. Scale range: 0 (Worst possible appearance) to 100 (Best possible appearance). Higher scores indicate better outcome.
1, 3, 6 months after treatment
Incidence of Adverse Events (AEs)
Lasso di tempo: From enrollment to 6 months after treatment
Incidence, time of onset, clinical manifestation, severity, treatment measures and outcome of all adverse events during the study period. Severity is graded according to CTCAE 5.0.
From enrollment to 6 months after treatment
Incidence of Toxin Diffusion-Related Adverse Events
Lasso di tempo: From enrollment to 6 months after treatment
Incidence of adverse events related to unintended botulinum toxin diffusion, including oral commissure asymmetry, lower lip movement disorder, salivation, dysarthria and abnormal smile.
From enrollment to 6 months after treatment
Incidence of Serious Adverse Events (SAEs)
Lasso di tempo: From enrollment to 6 months after treatment
Incidence of serious adverse events that result in death, life-threatening condition, hospitalization, persistent or significant disability, or congenital anomaly/birth defect.
From enrollment to 6 months after treatment
Patient Satisfaction Score (Visual Analog Scale, VAS)
Lasso di tempo: 1, 3, 6 months after treatment
Patient satisfaction measured by the 10-point Visual Analog Scale (VAS). Scale range: 0 (Completely dissatisfied) to 10 (Completely satisfied). Higher scores indicate higher satisfaction.
1, 3, 6 months after treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University

Investigatori

  • Investigatore principale: Xi Gong, D.D.S, Peking University School and Hospital of Stomatology
  • Investigatore principale: Minjie Chen, D.D.S, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
  • Investigatore principale: Jian Li, D.D.S, Wuhan University School of Stomatology
  • Investigatore principale: Yunpeng Li, D.D.S, School of Stomatology, Air Force Medical University
  • Investigatore principale: Sien Zhang, D.D.S, Guanghua School of Stomatology, Sun Yat-sen University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PekingUDAO

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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