Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07646886
PHASE4

Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis

Sponsor: Peking University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2026-07-01

Completion Date

2027-12-01

Last Updated

2026-06-15

Healthy Volunteers

No

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.