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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection) | Drug | Single subcutaneous injection of onabotulinumtoxinA into the upper half of the depressor anguli oris muscle, total dose 6U bilaterally. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Oral Commissure Ptosis Angle at Maximum Smile and Maximum Depression Position | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Gong, D.D.S | Contact | +86 15201304426 | 15201304426@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi Gong, D.D.S | Peking University School and Hospital of Stomatology | Principal Investigator |
| Minjie Chen, D.D.S | Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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This is a multicenter, prospective, randomized parallel-controlled clinical trial. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either upper depressor anguli oris (DAO) injection or lower DAO injection of Botulinum Toxin Type A. The efficacy and safety of the two injection regimens will be compared during a 6-month follow-up period.
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Single-blinded design for outcomes assessors only. All facial photographs and measurement data are anonymized with all group and time point information removed. Injecting physicians do not participate in any efficacy assessment. All outcomes are evaluated by 3 independent third-party assessors who are completely blinded to the group assignment. Subjects are informed that the study compares two different injection techniques but are not told their specific group assignment.
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| OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection) | Drug | Single subcutaneous injection of onabotulinumtoxinA into the lower half of the depressor anguli oris muscle, total dose 6U bilaterally. |
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| Vertical Elevation Amplitude of the Oral Commissure |
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 | 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) | 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) | 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) | 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 | 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) | 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) | 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 |
| Jian Li, D.D.S | Wuhan University School of Stomatology | Principal Investigator |
| Yunpeng Li, D.D.S | School of Stomatology, Air Force Medical University | Principal Investigator |
| Sien Zhang, D.D.S | Guanghua School of Stomatology, Sun Yat-sen University | Principal Investigator |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |