NCT05222607终止不适用
LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change
研究概览
简要总结
This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older.
- •Planning treatment with incobotulinumtoxinA.
排除标准
- •Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins.
- •Currently pregnant, breastfeeding, or intending to become pregnant during study participation.
- •Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients.
- •Any infection and/or inflammation at the planned injection points.
- •Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.
研究组 & 干预措施
Facial treatment with incobotulinumtoxinA in treatment naïve participants
干预措施: IncobotulinumtoxinA (Drug)
结局指标
主要结局
Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change
时间窗: Up to 3 years
Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change from first treatment visit to the 4-to-6 weeks timepoint.
次要结局
- Assessment of FACE-Q Satisfaction with Decision Scale mean change(Up to 3 years)
研究者
研究点 (1)
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