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Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

Recruitingn/aAges 18 Years - anyAllYuvell
NCT07398768 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Saypha® Rich
  • Saypha® Filler Lidocaine
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Where

1 site
YUVELL
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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