Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Austria34 participantsStarted 2026-02-13
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Participant already visiting the clinic for the specific treatment.
Exclusion criteria
. Pregnancy and breast feeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12