About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Saypha® Rich
- Saypha® Filler Lidocaine
Treatment groups
Sponsors and collaborators
Yuvell
Lead sponsor
Croma-Pharma GmbH
Collaborator