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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poly-L-lactin Acid (PLLA) Based Facial Injectable | Experimental | Poly-L-lactin Acid (PLLA) Based Facial Injectable |
|
| No treatment control | No Intervention | No treatment control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L-lactin Acid (PLLA) Based Facial Injectable | Device | Poly-L-lactin Acid (PLLA) Based Facial Injectable |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy rate of jawline contour deficit improvement (as evaluated by blinded evaluators, except for the primary efficacy index visit point) | 5, 12, 24 and 36 weeks | |
| Jawline contour deficit improvement score (as evaluated by blinded evaluators) | 5, 12, 24, 36 and 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MENG YAN | Contact | 020-89168071 | clinical.development@sinclairaesthetics.com | |
| ZHONGXING ZHANG | Contact | 020-89168071 | Medical.Committee@sinclairaesthetics.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongyi Zhao | Beijing Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China |
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| Change in FACE-QTM Satisfaction with Lower Face and Jawline score from the baseline (as evaluated by the subject) | 5, 12, 24 36 and 48 weeks |