A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
研究概览
简要总结
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.
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
- 否
入选标准
- •Participated with signed and dated informed consent form.
- •Men or women aged 18 years of age or older of Chinese origin.
- •Subjects who were seeking augmentation therapy for chin retrusion.
- •GCRS score of 1 or 2 as assessed by the Blinded Evaluator
排除标准
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
- •Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
- •History of severe or multiple allergies, manifested by anaphylaxis.
- •Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
- •Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
- •Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale.
- •Other condition that was preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
结局指标
主要结局
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
时间窗: At Month 6
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.
次要结局
- Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)(Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment)
- Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator(At Week 4 and Months 3, and 6)