A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12
研究概览
简要总结
The goal of this observational study is to learn how a perioral rejuvenation procedure affects perioral line severity and lip volume over time in adults undergoing routine aesthetic treatment in a single clinical center. The main questions it aims to answer are:
- What proportion of participants achieves a ≥1-point improvement from baseline on both the Lip Fullness Scale (LFS) and the Static Perioral Lines Assessment Scale (SPLAS) at Week 12?
- How do skin wrinkling/surface roughness, lip and perioral volume, and patient satisfaction change over 6 and 12 weeks?
Participants will:
- Receive a routine (non-study-mandated) holistic perioral rejuvenation procedure as decided by their treating clinician.
- Attend study visits at approximately baseline, Week 6, and Week 12.
- Undergo independent clinical assessments (assessor not involved in treatment delivery) of LFS and SPLAS.
- Have skin wrinkling and surface roughness documented by VISIA skin analysis (baseline, Week 6, Week 12).
- Have lip and perioral volume measured by VECTRA M3 volume analysis (baseline, Week 6, Week 12).
- Complete a standardized patient satisfaction questionnaire (Week 12).
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 —（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 static perioral lines and maximum of thin lips, as assessed by the investigator.
- •Participant has a stable medical condition with no uncontrolled systemic disease.
- •Willingness to participate in the routine follow-up after 12 weeks and a signed ICF.
- •Participant already visiting the clinic for the specific treatment.
排除标准
- •Pregnancy and breast feeding.
- •Known impairment of blood coagulation.
- •Presence of acute infection or inflammation at the proposed injection sites.
- •Hyaluronic Acid-Filler treatment in the perioral area within the last 6 months.
- •Patients with a history of autoimmune disease or who are receiving immune therapy.
- •History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amidetype local anaesthetics.
结局指标
主要结局
Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12
时间窗: Week 12
Proportion of participants achieving a combined responder status, defined as an improvement of at least 1 point from baseline on both perioral line severity and lip fullness at Week 12, as assessed by an independent investigator not involved in treatment procedures, using the following validated photo-numeric scales: * Upper and lower lip fullness assessed using the Lip Fullness Scale (LFS), a validated 5-point photo-numeric rating scale ranging from Grade 1 (very thin) to Grade 5 (full), where higher scores indicate greater lip fullness. The upper and lower lips are graded separately. * Static perioral line severity assessed using the Static Perioral Lines Assessment Scale (SPLAS), a photo-numeric scale ranging from 1 (none) to 5 (very severe), where higher scores indicate greater severity of perioral lines. A participant is considered a responder only if the ≥ 1-point improvement criterion is met on both the LFS and the SPLAS simultaneously relative to baseline.
次要结局
- Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIA® skin analysis(Week 6, Week 12)
- Change in combined upper and lower lip fullness assessed by the Lip Fullness Scale (LFS)(Week 6, Week 12)
- Change in perioral line severity assessed by the Static Perioral Lines Assessment Scale (SPLAS)(Week 6, Week 12)
- Change in lip and perioral volume assessed by three-dimensional (3D) facial imaging(Week 6, Week 12)
- Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire(Week 12)