DRKS00031121已完成4 期
Open-label, multicenter, uncontrolled, rater-blinded, post-market clinical follow up (PMCF) study to confirm performance and safety of Belotero® Soft Lidocaine and Belotero® Intense Lidocaine in the treatment of nasolabial folds, perioral fine lines and/or for lip volume enhancement - BiSoLi
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
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
- •Subjects seeking for hyaluronic acid (HA) dermal filler/volumizing treatment in the face to correct at least two of the following regions:
- •a. Nasolabial folds;
- •b. Upper and lower lip volume; and
- •c. Perioral fine lines.
- •Depending on the area to be treated, the following criteria apply:
- •Nasolabial folds volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Nasolabial Folds Scale (MNLFS) with symmetrical rating;
- •Upper and lower lips volume deficit of very thin to moderately thick intensity (grade 0 to 2) on the Merz Lip Fullness Scale (MLFS); and
- •Perioral fine lines with a rating of mild to moderate grading (grade 1 to 2) on the validated Merz Lip Wrinkle Scale (MLWS).
排除标准
- •Prior treatment within the past 18 months with calcium hydroxylapatite in the area to be treated;
- •Prior treatment within the past 12 months with HA filler in the areas to be treated; and
- •Prior treatment within the past three months with dermal therapies (e.g., toxin treatments, facial ablative or fractional laser, microdermabrasion, chemical peels, and non-invasive skin-tightening) in the areas to be treated.
研究者
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