Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07398768

Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

Sponsor: Yuvell

View on ClinicalTrials.gov

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).

Official title: A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

34

Start Date

2026-02-13

Completion Date

2026-07

Last Updated

2026-03-13

Healthy Volunteers

Yes

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.

Locations (1)

YUVELL

Vienna, Vienna, Austria