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RecruitingNot ApplicableNCT06394076

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

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

Sponsor

Sinclair Pharmaceuticals Limited

Enrollment

172 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

Infraorbital Hollowing

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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).
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Interventions

DEVICECross-linked sodium hyaluronate gel for injection containing lidocaine

Cross-linked sodium hyaluronate gel for injection containing lidocaine

Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT06394076