Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of MAILI PRECISE With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-linked sodium hyaluronate gel for injection containing lidocaine | Experimental | Cross-linked sodium hyaluronate gel for injection containing lidocaine |
|
| No treatment control | No Intervention | No treatment control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-linked sodium hyaluronate gel for injection containing lidocaine | Device | Cross-linked sodium hyaluronate gel for injection containing lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| At 3 months after the last treatment in the experimental group, and 3 months after the randomization of the control group, blinded evaluators will use AIHS to evaluate the improvement rate of the infraorbital hallowing. | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| At one month after the last injection in the experimental group, and at one month after randomization in the control group, the Allergan Infraorbital Hollowing Scale (AIHS) rating will be evaluated by a blinded investigator | 1 month | |
| At 1 month and 3 months after the last treatment in the experimental group, and at 1 month and 3 months after randomization in the control group, the injection investigator will use AIHS to evaluate the improvement rate of the infraorbital hallowing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|
| Hongsen Bi | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 month and 3 month |