A Prospective, Non-interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Yuvell
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of subjects with a combined ≥ 1-point improvement in glabellar lines, forehead lines, and crow's feet severity at Week 2
概览
简要总结
The goal of this observational study is to learn about the safety, tolerability, and effectiveness of Letibotulinumtoxin A for the holistic treatment of the upper face in adults under 75 years old with moderate to severe upper facial lines, including glabellar lines, forehead lines, and lateral canthal lines.
The main questions it aims to answer are:
- Does Letibotulinumtoxin A safely and effectively reduce the severity of glabellar lines, forehead lines, and lateral canthal lines in adults under 75?
- How well is the treatment tolerated in everyday clinical practice?
- What is the patient satisfaction with holistic upper face treatment using Letibotulinumtoxin A?
Participants will:
- receive Letibotulinumtoxin A injections in the upper face, including glabellar lines, forehead lines, and lateral canthal lines.
- be observed and followed up to assess the severity of wrinkles, duration of effect, and patient satisfaction.
- report any adverse effects experienced during or after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older at time of treatment.
- •At least mild frown lines at maximum frown, mild dynamic forehead lines at maximum eyebrow elevation or mild crow's feet at maximum smile.
- •Subject has a stable medical condition with no uncontrolled systemic disease.
- •Willingness to participate in the routine follow - up after 2 weeks and 4 months and a signed informed consent form.
排除标准
- •Pregnancy and breast feeding.
- •Neuromuscular disease (e.g. myasthenia gravis, Eaton - Lambert syndrome).
- •Known impairment of blood coagulation.
- •Drooping eyelid.
- •Known allergy to botulinum toxin or human albumin (blood protein).
- •Presence of acute infection or inflammation at the proposed injection sites.
- •Botulinumtoxin treatment in the upper face within the last 16 weeks.
结局指标
主要结局
Proportion of subjects with a combined ≥ 1-point improvement in glabellar lines, forehead lines, and crow's feet severity at Week 2
时间窗: Week 2
Proportion of subjects achieving a combined responder status, defined as an improvement of at least 1 point from baseline in all 3 treated facial regions at Week 2, as assessed by the investigator using the following validated photo-numeric scales: * Vertical glabellar lines assessed at maximum frowning using the Facial Wrinkle Scale (FWS), a scale ranging from 0 to 3, where higher scores indicate greater wrinkle severity. * Forehead lines assessed at maximum eyebrow elevation using the Croma Dynamic Forehead Line Assessment Scale (CDFLAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity. * Crow's feet assessed at maximum smiling using the Croma Dynamic Crow's Feet Assessment Scale (CDCFAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity. A subject is considered a responder only if the ≥ 1-point improvement criterion is met for all 3 scales simultaneously.
次要结局
- Change in vectorial skin displacement at maximum frowning assessed by three-dimensional (3D) surface imaging(Week 2, Week 16)
- Change in vectorial skin displacement during maximum frontalis muscle contraction assessed by three-dimensional (3D) surface imaging(Week 2, Week 16)
- Change in vectorial skin displacement during maximum orbicularis oculi muscle contraction assessed by three-dimensional (3D) surface imaging(Week 2, Week 16)
- Percentage of subjects requiring a touch-up at Week 2(Week 2)
- Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire(Week 16)