Injectable gel for treating under-eye hollows in Chinese patients

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

This study is testing if an injectable gel can safely improve the appearance of under-eye hollows in Chinese patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 172 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sinclair Pharmaceuticals Limited (industry)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06394076 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of an injectable gel containing cross-linked sodium hyaluronate with lidocaine for correcting infraorbital hollowing in the Chinese population. It is a multicenter, evaluator-blinded, randomized, no-treatment controlled study, meaning participants will be randomly assigned to receive either the treatment or no treatment at all, with evaluators unaware of which participants received the gel. The study aims to determine if the gel can effectively improve the appearance of under-eye hollows as assessed by a standardized scale.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 or older with moderate to severe infraorbital hollowing as assessed by a blinded evaluator.

Not a fit: Patients with mild infraorbital hollowing or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the aesthetic appearance of patients suffering from infraorbital hollowing.

How similar studies have performed: While similar injectable treatments have shown success in other populations, this specific approach in the Chinese demographic is novel.

Eligibility criteria

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).

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Hongsen Bi — Peking University Third Hospital
• Study coordinator: MENG YAN

Conditions: Infraorbital Hollowing