DRKS00031802已完成4 期
Open-label, Multi-center, Randomized, Parallel-group, Post-Market Clinical Follow-Up Investigation to Evaluate the Clinical Performance and Safety of Belotero® Volume and Belotero® Volume Lidocaine for Chin Augmentation - BeVoC
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Willing to abstain from all procedures in the face during the study
- •- Subject with a G-Sn-Pg angle of 155° to 170° at Screening visit
排除标准
- •- Severe microgenia
- •- Previous treatment with silicone, polymethyl methacrylate, fat injections, poly L lactic acid, chin-implants or other permanent dermal fillers below the nose
- •- Surgeries below the nose and facial surgeries in the last 2 years that could potentially affect the area of the chin
- •- Treatment with dermal therapies in the chin area within the past 3 months
- •- Actinic damaged skin and/or premature skin aging in the area to be treated
- •- Acute inflammatory process or infection at the injection site or history of chronic or recurrent infection or inflammation with potential to interfere with study results or increase risk of adverse events (AEs)
- •- Any medical condition with the potential to interfere with the study or increase risk of AEs
研究者
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