Jawline Contour DeficitNCT06391580
A Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit
A study testing Poly-L-lactin Acid (PLLA) Based Facial Injectable in people with Jawline Contour Deficit, run by Sinclair Pharmaceuticals Limited at 1 site in China.
Trial summary
A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jawline Contour Deficit
- What is being tested?
- Poly-L-lactin Acid (PLLA) Based Facial Injectable
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who aged 18 years or older (subject to the date of signing the informed consent), male or female;
- Subjects with a MJAS score of moderate to severe levels (2~3 scores) in terms of bilateral jawline contour as evaluated by the blinded evaluator, and the scores of bilateral jawline contour must meet the criteria but not required to be the same;
- Subjects who are seeking to receive corrective treatment for jawline contouring;
- Subjects who are in good health and suitable to receive corrective treatment for jawline contouring as evaluated by the blinded evaluator;
- Subjects who voluntarily sign the ICF, understand and accept the study duration, and are able to comply with all requirements including treatment, follow-ups and other study procedures as scheduled;
Who cannot join
- Subjects with non-aging skin laxity and lipoatrophy which may affect the evaluation of efficacy in the midface or mandibular region as identified by the investigator;
- Subjects who are known to be allergic to any local anesthetics (such as lidocaine or other amide anesthetics), or have a history of severe allergic reactions or anaphylactic shock;
- Subjects who have residual defects, scars, deformities, tattoos, perforations, hair, unhealed wounds, active skin diseases or inflammations (such as eczema, acnes, psoriasis, and herpes zoster), abscesses, carcinogenesis or precancerous lesions and other conditions that may affect evaluation of vision and efficacy or increase the risk of treatment in the injection and evaluation areas;
- Subjects with unstable and/or irreproducible malocclusion, or bruxism, hypertrophy or asymmetry of masseter, lockjaw, active temporomandibular disorders or active periodontal diseases;
- Subjects who have a tendency to develop keloids, hypertrophic scars, or any other healing disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Hospital
Beijing, Beijing Municipality
Hongyi Zhao, zhaohy@163.com
About this study
Official title: A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit
A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit
- Conditions
- Jawline Contour Deficit
- Being tested
- Poly-L-lactin Acid (PLLA) Based Facial Injectable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-lactin Acid (PLLA) Based Facial InjectableDevice
Poly-L-lactin Acid (PLLA) Based Facial Injectable
| Study group | Role | What they receive |
|---|---|---|
| Poly-L-lactin Acid (PLLA) Based Facial Injectable | Experimental | Poly-L-lactin Acid (PLLA) Based Facial Injectable Receives: Device: Poly-L-lactin Acid (PLLA) Based Facial Injectable |
| No treatment control | No intervention | No treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy rate of jawline contour deficit improvement in the test group at 48 weeks after the last injection and that in the control group at 48 weeks after randomization, evaluated by blinded evaluators using the MJAS.
Measured: 48 weeks
Secondary outcomes (3)
Efficacy rate of jawline contour deficit improvement (as evaluated by blinded evaluators, except for the primary efficacy index visit point)
Measured: 5, 12, 24 and 36 weeks
Jawline contour deficit improvement score (as evaluated by blinded evaluators)
Measured: 5, 12, 24, 36 and 48 weeks
Change in FACE-QTM Satisfaction with Lower Face and Jawline score from the baseline (as evaluated by the subject)
Measured: 5, 12, 24 36 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jawline Contour DeficitStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinclair Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongyi Zhao, Principal investigator, Beijing Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391580
- Sponsor's protocol ID
- HDM6010A-301
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit
- ClinicalTrials.gov ID
- NCT06391580
- Acronym / sponsor ID
- HDM6010A-301
- Conditions
- Jawline Contour Deficit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Sinclair Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poly-L-lactin Acid (PLLA) Based Facial Injectable | Experimental | Device: Poly-L-lactin Acid (PLLA) Based Facial InjectablePoly-L-lactin Acid (PLLA) Based Facial Injectable |
| No treatment control | No intervention | –No treatment control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who aged 18 years or older (subject to the date of signing the informed consent), male or female;
- Subjects with a MJAS score of moderate to severe levels (2~3 scores) in terms of bilateral jawline contour as evaluated by the blinded evaluator, and the scores of bilateral jawline contour must meet the criteria but not required to be the same;
- Subjects who are seeking to receive corrective treatment for jawline contouring;
- Subjects who are in good health and suitable to receive corrective treatment for jawline contouring as evaluated by the blinded evaluator;
- Subjects who voluntarily sign the ICF, understand and accept the study duration, and are able to comply with all requirements including treatment, follow-ups and other study procedures as scheduled;
Key exclusion criteria (5 listed)
- Subjects with non-aging skin laxity and lipoatrophy which may affect the evaluation of efficacy in the midface or mandibular region as identified by the investigator;
- Subjects who are known to be allergic to any local anesthetics (such as lidocaine or other amide anesthetics), or have a history of severe allergic reactions or anaphylactic shock;
- Subjects who have residual defects, scars, deformities, tattoos, perforations, hair, unhealed wounds, active skin diseases or inflammations (such as eczema, acnes, psoriasis, and herpes zoster), abscesses, carcinogenesis or precancerous lesions and other conditions that may affect evaluation of vision and efficacy or increase the risk of treatment in the injection and evaluation areas;
- Subjects with unstable and/or irreproducible malocclusion, or bruxism, hypertrophy or asymmetry of masseter, lockjaw, active temporomandibular disorders or active periodontal diseases;
- Subjects who have a tendency to develop keloids, hypertrophic scars, or any other healing disorders.
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 |
|---|---|---|
| Poly-L-lactin Acid (PLLA) Based Facial InjectablePoly-L-lactin Acid (PLLA) Based Facial Injectable | Device | Poly-L-lactin Acid (PLLA) Based Facial Injectable |
Primary outcome
Efficacy rate of jawline contour deficit improvement in the test group at 48 weeks after the last injection and that in the control group at 48 weeks after randomization, evaluated by blinded evaluators using the MJAS.
Time frame: 48 weeks
3 secondary outcomes
Efficacy rate of jawline contour deficit improvement (as evaluated by blinded evaluators, except for the primary efficacy index visit point)
Time frame: 5, 12, 24 and 36 weeks
Jawline contour deficit improvement score (as evaluated by blinded evaluators)
Time frame: 5, 12, 24, 36 and 48 weeks
Change in FACE-QTM Satisfaction with Lower Face and Jawline score from the baseline (as evaluated by the subject)
Time frame: 5, 12, 24 36 and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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. This study is not recruiting at the moment.
Hongyi Zhao principal investigator
Beijing Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-lactin Acid (PLLA) Based Facial Injectable in people with Jawline Contour Deficit, run by Sinclair Pharmaceuticals Limited at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MENG YAN (020-89168071, clinical.development@sinclairaesthetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy rate of jawline contour deficit improvement in the test group at 48 weeks after the last injection and that in the control group at 48 weeks after randomization, evaluated by blinded evaluators using the MJAS. (time frame: 48 weeks). 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 30 Apr 2024.