Clinical trial NCT06394076: A Study to Evaluate the Safety and Effectiveness of Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infraorbital Hollowing
Lead sponsor: Sinclair Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: 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.
timeFrame: 3 month
Secondary outcomes:
measure: 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
timeFrame: 1 month
measure: 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
timeFrame: 1 month and 3 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hongsen Bi
role: PRINCIPAL_INVESTIGATOR
References: