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Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis

NCT07646886 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • Facial Aging
  • Melomental Folds
  • Oral Commissure Ptosis

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Xi Gong, D.D.S · Peking University School and Hospital of Stomatology

  • Minjie Chen, D.D.S · Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  • Jian Li, D.D.S · Wuhan University School of Stomatology

  • Yunpeng Li, D.D.S · School of Stomatology, Air Force Medical University

  • Sien Zhang, D.D.S · Guanghua School of Stomatology, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-01
Completion
2027-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646886 on ClinicalTrials.gov