Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

Официальное название

A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure

Обзор

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).

Вмешательства

• Устройство Saypha® Rich
  Device is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use.
• Устройство Saypha® Filler Lidocaine
  Device is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use.

Первичные конечные точки

• Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12 [Срок оценки: Week 12]

Вторичные конечные точки (5)

• Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIA® skin analysis [Срок оценки: Week 6, Week 12]
• Change in combined upper and lower lip fullness assessed by the Lip Fullness Scale (LFS) [Срок оценки: Week 6, Week 12]
• Change in perioral line severity assessed by the Static Perioral Lines Assessment Scale (SPLAS) [Срок оценки: Week 6, Week 12]
• Change in lip and perioral volume assessed by three-dimensional (3D) facial imaging [Срок оценки: Week 6, Week 12]
• Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire [Срок оценки: Week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• YUVELL — Vienna

Идентификаторы

NCT: NCT07398768 · YUV-NIS-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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