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

Sinclair Pharmaceuticals Limited1 site in 1 country172 target enrollmentDecember 27, 2023

ConditionsInfraorbital Hollowing

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infraorbital Hollowing
Sponsor: Sinclair Pharmaceuticals Limited
Enrollment: 172
Locations: 1
Primary Endpoint: 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.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 27, 2023

End Date

April 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sinclair Pharmaceuticals Limited

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Time Frame: 3 month

Secondary Outcomes

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)
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)