NCT06394076招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
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.
时间窗: 3 month
次要结局
- 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(1 month and 3 month)
- 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(1 month)
研究者
研究点 (1)
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