A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Extended Periorbital Rejuvenation Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in skin wrinkling in periorbital area at Week 8
研究概览
简要总结
The goal of this observation is to assess the time course of holistic extended periorbital rejuvenation using botulinum toxin A, cross-linked hyaluronic acid and polynucleotides corresponding to the application in routine practice in adults. It will also document the safety of treatment procedure and patient satisfaction.
The main questions it aims to answer are:
- How does a holistic extended periorbital rejuvenation procedure using botulinum toxin A, cross-linked hyaluronic acid filler, and polynucleotides change skin wrinkling around the eye area over time (particularly after 8 and 22 weeks)?
- How does the treatment affect the severity of dynamic glabellar lines at 8 and 22 weeks?
- Does the procedure improve midface volume deficiency after 8 and 22 weeks?
- How satisfied are participants with the overall rejuvenation treatment?
The investigator will observe the combination treatment of a drug Letybo® and medical devices PhilArt® Eye and Saypha® Volume Plus Lidocaine within their approved indications (non-interventional study, on-label use). The combination treatment aims to rejuvenate and improve the eye area holistically in patients coming routinely to the clinic.
Participants will:
- take PhilArt® Eye on Week 0 (Baseline), 3 and 6; Saypha® Volume Plus Lidocaine on Week 0 (Baseline); Letybo® on Week 6.
- visit the clinic on Week 0 (Baseline), 3, 6, 8 and 22 as per clinical practice for checkups and satisfaction assessment.
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 periorbital skin wrinkling, mild frown lines at maximum frown and mild.
- •midface volume deficiency as assessed by the investigator
- •Subject has a stable medical condition with no uncontrolled systemic disease.
- •Willingness to participate in the routine follow-up after 8 weeks and 22 weeks and a signed informed consent form.
- •Subject already visiting the clinic for the specific treatment.
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.
- •Botulinum toxin treatment in the glabella within the last 16 weeks.
- •HA- Filler treatment in the midface or periorbital 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.
- •History of fish product allergy.
研究组 & 干预措施
Single Observational Cohort
Participants receiving routine clinical care/undergoing the rejuvenation procedure.
干预措施: Letybo® (Drug)
Single Observational Cohort
Participants receiving routine clinical care/undergoing the rejuvenation procedure.
干预措施: Philart® Eye (Device)
Single Observational Cohort
Participants receiving routine clinical care/undergoing the rejuvenation procedure.
干预措施: Saypha® Volume Plus Lidocaine (Device)
结局指标
主要结局
Change in skin wrinkling in periorbital area at Week 8
时间窗: Week 8
Change in the percentage of skin wrinkling in the periorbital area from baseline to Week 8, as assessed using VISIA® skin analysis. Skin wrinkling is quantified as a percentage-based measurement derived from standardized VISIA imaging of the area around the eye. The outcome is expressed as the percent change relative to baseline, with higher percentages indicating an improvement, which equals a reduction in skin wrinkling.
次要结局
- Change in skin wrinkling in the periorbital area at Week 22(Week 22)
- Change in severity of dynamic glabellar lines at Week 8 and Week 22(Week 8, Week 22)
- Change from baseline in midface volume deficit severity, assessed at Week 8 and Week 22 by the investigator using the Midface Volume Deficit Severity Score (MVDSS)(Week 8, Week 22)
- Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire(Week 22)