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

Recruiting
18 years of age
Both
Phase N/A

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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:

  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).

Study details

Infraorbital Hollowing

NCT06394076

Sinclair Pharmaceuticals Limited

15 May 2024

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