NCT07398768 Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
| NCT ID | NCT07398768 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yuvell |
| Condition | Perioral Wrinkles |
| Study Type | OBSERVATIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 34 participants in total. It began in 2026-02-13 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07398768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perioral Wrinkles. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07398768 currently recruiting?
Yes, NCT07398768 is actively recruiting participants. Contact the research team at mia.cajkovsky@yuvell.at for enrollment information.
Where is the NCT07398768 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07398768 clinical trial?
NCT07398768 is sponsored by Yuvell. The trial plans to enroll 34 participants.