Overview
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
Eligibility
Inclusion Criteria:
- Aged 18 or above (subject to the time of signing the informed consent form) , gender is not limited;
- 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;
- The injection investigator believes that the hallowing of the infraorbital rim area of the subject can be corrected to grade 0 or grade 1;
- 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 ;
- 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);
- Volunteer to participate in this clinical trial and sign the Informed Consent Form.
Exclusion Criteria:
- Atrophy in the infraorbital area;
- Previous trauma to the infraorbital area, or residual defects, deformities, or scarring in the periorbital or cheek area before screening;
- The investigator considers that there is a large lower eyelid fat pad that will affect the treatment outcome;
- The front most part of the eyeball protrudes forward more than the front most part of the cheek;
- Hyperpigmentation in the infraorbital area (excluding dark circles which are not caused by hyperpigmentation).