DRKS00031795已完成4 期
Open-label, multi-center, uncontrolled, post-market clinical follow-up (PMCF) investigation to confirm effectiveness and safety of Belotero® Balance Lidocaine in the treatment of horizontal forehead lines - BeFore
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
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
- N/a: Single Arm 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
- •Seeks hyaluronic acid (HA) dermal filler treatment for horizontal forehead lines
- •- Horizontal forehead lines with a mild to severe grade on the validated MASFL - At Rest rating
- •- Willing to abstain from all surgical and non-surgical aesthetic procedures in the forehead and adjacent regions during study participation
排除标准
- •- Previous treatment with silicone, polymethyl methacrylate, fat injections, poly L lactic acid, or permanent dermal fillers in the forehead and adjacent regions (e.g., crow´s feet, temple, and glabella)
- •- Actinic damaged skin and/or premature skin aging in the forehead
- •- Acute inflammatory process or infection at the injection site or history of chronic or recurrent infection or inflammation that could interfere with the investigation results
- •- Any medical condition that could interfere with the investigation or increase the risk of Adverse Events
研究者
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