DRKS00031800已完成4 期
Randomized, rater-blinded, uncontrolled, multi-center post-market clinical follow-up (PMCF) investigation to confirm effectiveness and safety of Belotero® Intense and Belotero® Intense Lidocaine in the treatment of nasolabial folds, marionette lines, and lip volume enhancement - Belinda
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Subject seeks Hyaluronic acid (HA) dermal filler/volumizing treatment in the face to correct at least two of the following facial areas:
- •oNasolabial folds
- •oMarionette lines
- •oUpper and lower lip volume
- •- In case nasolabial folds will be treated: Nasolabial folds volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Nasolabial Folds Scale (MNLFS) as determined independently by the treating investigator and the blinded rater.
- •- In case marionette lines will be treated: Marionette lines volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Marionette Lines Scale (MMLS) as determined independently by the treating investigator and the blinded rater.
- •- In case upper and lower lips will be treated: Upper and lower lip volume deficit of very thin to moderately thick intensity (grade 0 to 2) on the Merz Lip Fullness Assessment Scale (MLFAS) as determined independently by the treating investigator and the blinded rater.
- •- Willing to abstain from all procedures in the face during study participation
排除标准
- •- Any previous treatment with silicone, polymethyl methacrylate, fat injections, poly L lactic acid or permanent dermal fillers in the face
- •- Prior surgery, including facial plastic surgery, or has a permanent implant or graft, thread lift or any unknown treatments within the past 2 years in the lower third part of the face including the nose that could interfere with effectiveness assessments
- •- Prior treatment within the past 18 months with calcium hydroxylapatite in the areas to be treated
- •- Prior treatment within the past 12 months with HA filler in the areas to be treated
- •- Prior treatment within the past 3 months with dermal therapies in the areas to be treated
- •- Planned surgery or dermal therapies in the face during study participation
- •- Cosmetic treatment (e.g., facials) or home peeling in the past 4 weeks
研究者
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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 enhancementFacial soft tissue augmentationDRKS00031121Merz Aesthetics GmbH220