NCT07398768

Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 34 (estimated)
• Sponsor: Yuvell · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Perioral Wrinkles
• Crow's Feet
• Lip Volume Enhancement
• Lip Aging

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-02-13
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-02-10
• Last updated: 2026-03-13

Locations

1 site across 1 country: Austria