A Multi-Centre, Evaluator-Blinded Study to Evaluate Efficacy and Safety of R Volumizer for Cheek Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Galderma R&D
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Percentage of Responders in Midface Fullness Using Photo Scale
研究概览
简要总结
A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.
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
- Double (Participant, 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
- •Provide a signed and dated informed consent to participate in the study including release of copyright of images
- •Man or woman aged 18 years or older
- •Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area
排除标准
- •Known/previous allergy or hypersensitivity to any injectable HA gel
- •History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment
- •Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment
- •Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated
- •The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason
研究组 & 干预措施
HA experimental
HA experimental only
干预措施: HA experimental (Device)
HA comparator
HA experimental + HA comparator
干预措施: HA experimental (Device)
HA comparator
HA experimental + HA comparator
干预措施: HA comparator (Device)
结局指标
主要结局
Percentage of Responders in Midface Fullness Using Photo Scale
时间窗: 3 months
Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.
次要结局
- Percentage of Responders in Midface Fullness Using Photo Scale(15 months)