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

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).

Inclusion Criteria:

1. 18 years or older at time of treatment.
2. At least mild static perioral lines and maximum of thin lips, as assessed by the investigator.
3. Participant has a stable medical condition with no uncontrolled systemic disease.
4. Willingness to participate in the routine follow-up after 12 weeks and a signed ICF.
5. Participant already visiting the clinic for the specific treatment.

Exclusion Criteria:

1. Pregnancy and breast feeding.
2. Known impairment of blood coagulation.
3. Presence of acute infection or inflammation at the proposed injection sites.
4. Hyaluronic Acid-Filler treatment in the perioral area within the last 6 months.
5. Patients with a history of autoimmune disease or who are receiving immune therapy.
6. History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amidetype local anaesthetics.