Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saypha® Rich, Saypha® Filler Lidocaine.
- Who it may be relevant to
- Registry conditions: Perioral Wrinkles, Crow's Feet, Lip Volume Enhancement, Lip Aging. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure
Overview
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).
Interventions
- Device Saypha® 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. - Device Saypha® 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.
Primary outcome measures
- Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12 [Time frame: Week 12]
Secondary outcome measures (5)
- Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIA® skin analysis [Time frame: Week 6, Week 12]
- Change in combined upper and lower lip fullness assessed by the Lip Fullness Scale (LFS) [Time frame: Week 6, Week 12]
- Change in perioral line severity assessed by the Static Perioral Lines Assessment Scale (SPLAS) [Time frame: Week 6, Week 12]
- Change in lip and perioral volume assessed by three-dimensional (3D) facial imaging [Time frame: Week 6, Week 12]
- Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire [Time frame: Week 12]
Eligibility criteria
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- YUVELL — Vienna
Identifiers
NCT: NCT07398768 · YUV-NIS-003