Infraorbital Hollowing
Conditions
Brief summary
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
Interventions
DEVICECross-linked sodium hyaluronate gel for injection containing lidocaine
Cross-linked sodium hyaluronate gel for injection containing lidocaine
Sponsors
Sinclair Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 or above (subject to the time of signing the informed consent form) , gender is not limited; 2. According to Allergan Infraorbital Rim Scale (AIHS), the subjects were judged by blinded evaluator as having moderate or severe infraorbital rim hallowing (grade 2-3) in each eye, and both eyes must meet the requirements but do not need to have the same score; 3. The injection investigator believes that the hallowing of the infraorbital rim area of the subject can be corrected to grade 0 or grade 1; 4. Able and willing to follow the investigator's guidance, following the treatment restrictions in this protocol, and completing all the visits of this trial as required ; 5. Able to complete the self-assessment of effectiveness without the use of glasses (contact lenses are accepted if the subject wear contact lenses for all the follow-up visits); 6. Volunteer to participate in this clinical trial and sign the Informed Consent Form.
Exclusion criteria
1. Atrophy in the infraorbital area; 2. Previous trauma to the infraorbital area, or residual defects, deformities, or scarring in the periorbital or cheek area before screening; 3. The investigator considers that there is a large lower eyelid fat pad that will affect the treatment outcome; 4. The front most part of the eyeball protrudes forward more than the front most part of the cheek; 5. Hyperpigmentation in the infraorbital area (excluding dark circles which are not caused by hyperpigmentation).
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 1 month and 3 month |
Countries
China
Contacts
Primary ContactMENG YAN
Backup ContactZHONGXING ZHANG
Outcome results
None listed