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Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis

3. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

266

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: 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.
Andere Namen:
  • Botox®
Aktiver Komparator: 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
Arzneimittel: 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.
Andere Namen:
  • Botox®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Improvement of Oral Commissure Ptosis Angle at Maximum Smile and Maximum Depression Position
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking University

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PekingUDAO

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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