Facial AgingPhase 4NCT07646886
Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis
A Phase 4 study testing OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection) and OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection) in people with Facial Aging and Melomental Folds, run by Peking University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Facial Aging, Melomental Folds, Oral Commissure Ptosis
- What is being tested?
- OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection) and OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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°)
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Facial Aging, Melomental Folds, Oral Commissure Ptosis
- Being tested
- OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection), OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)
- Keywords
- Botulinum Toxin Type A, Oral Commissure Ptosis, Melomental Folds, Depressor Anguli Oris Muscle, Randomized Controlled Trial, Injection Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection)Drug
Also called Botox®
Single subcutaneous injection of onabotulinumtoxinA into the upper half of the depressor anguli oris muscle, total dose 6U bilaterally.
OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)Drug
Also called Botox®
Single subcutaneous injection of onabotulinumtoxinA into the lower half of the depressor anguli oris muscle, total dose 6U bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| 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.
* 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 Receives: Drug: OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection) |
| 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.
* 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 Receives: Drug: OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30±3 days after treatment
Secondary outcomes (9)
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.
Measured: 1, 3, 6 months after treatment
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1, 3, 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AgingStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xi Gong, D.D.S, Principal investigator, Peking University School and Hospital of StomatologyMinjie Chen, D.D.S, Principal investigator, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineJian Li, D.D.S, Principal investigator, Wuhan University School of StomatologyYunpeng Li, D.D.S, Principal investigator, School of Stomatology, Air Force Medical UniversitySien Zhang, D.D.S, Principal investigator, Guanghua School of Stomatology, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646886
- Sponsor's protocol ID
- PekingUDAO
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Site-Based Multicenter Randomized Controlled Trial: Efficacy and Safety of Focal Botulinum Toxin Type A Injection for Oral Commissure Ptosis
- ClinicalTrials.gov ID
- NCT07646886
- Acronym / sponsor ID
- PekingUDAO
- Conditions
- Facial Aging, Melomental Folds, Oral Commissure Ptosis
- Keywords
- Botulinum Toxin Type A, Oral Commissure Ptosis, Melomental Folds, Depressor Anguli Oris Muscle, Randomized Controlled Trial, Injection Site
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Upper Depressor Anguli Oris Injection | Experimental | Drug: OnabotulinumtoxinA (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 |
| Lower Depressor Anguli Oris Injection | Active comparator | Drug: OnabotulinumtoxinA (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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection)Also: Botox®Single subcutaneous injection of onabotulinumtoxinA into the upper half of the depressor anguli oris muscle, total dose 6U bilaterally. | Drug | Upper Depressor Anguli Oris Injection |
| OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection)Also: Botox®Single subcutaneous injection of onabotulinumtoxinA into the lower half of the depressor anguli oris muscle, total dose 6U bilaterally. | Drug | Lower Depressor Anguli Oris Injection |
Primary outcome
Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment
Time frame: 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.
9 secondary outcomes
Improvement of Oral Commissure Ptosis Angle at Maximum Smile and Maximum Depression Position
Time frame: 1, 3, 6 months after treatment
Vertical Elevation Amplitude of the Oral Commissure
Time frame: 1, 3, 6 months after treatment
Merz Facial Aesthetic Scale Score
Time frame: 1, 3, 6 months after treatment
Global Aesthetic Improvement Scale (GAIS)
Time frame: 1, 3, 6 months after treatment
Patient Satisfaction Score (FACE-Q)
Time frame: 1, 3, 6 months after treatment
Incidence of Adverse Events (AEs)
Time frame: From enrollment to 6 months after treatment
Incidence of Toxin Diffusion-Related Adverse Events
Time frame: From enrollment to 6 months after treatment
Incidence of Serious Adverse Events (SAEs)
Time frame: From enrollment to 6 months after treatment
Patient Satisfaction Score (Visual Analog Scale, VAS)
Time frame: 1, 3, 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xi Gong, D.D.S principal investigator
Peking University School and Hospital of Stomatology
Minjie Chen, D.D.S principal investigator
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Jian Li, D.D.S principal investigator
Wuhan University School of Stomatology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection) and OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection) in people with Facial Aging and Melomental Folds, run by Peking University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi Gong, D.D.S (+86 15201304426, 15201304426@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Bilateral Oral Commissure Ptosis Angle from Baseline at 1 Month Post-Treatment (time frame: 30±3 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.