RecruitingNCT07398768

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


Sponsor

Yuvell

Enrollment

34 participants

Start Date

Feb 13, 2026

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria6

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICESaypha® 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.

DEVICESaypha® 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.


Locations(1)

YUVELL

Vienna, Vienna, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07398768


Related Trials