A Study to Evaluate the Safety and Effectiveness of Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population

Sinclair Pharmaceuticals Limited

Status: Enrolling

Conditions: Infraorbital Hollowing

Treatments: Device: Cross-linked sodium hyaluronate gel for injection containing lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06394076

HDM6008A-301

Details and patient eligibility

About

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

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

Cross-linked sodium hyaluronate gel for injection containing lidocaine

Experimental group

Description:

Cross-linked sodium hyaluronate gel for injection containing lidocaine

Treatment:

Device: Cross-linked sodium hyaluronate gel for injection containing lidocaine

No treatment control

No Intervention group

Description:

No treatment control