MedTrace Logo

Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

NCT07398768 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2026-03-13

No results posted yet for this study

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).

Conditions

  • Perioral Wrinkles
  • Crow's Feet
  • Lip Volume Enhancement
  • Lip Aging

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.

Sponsors & Collaborators

  • Croma-Pharma GmbH

    collaborator INDUSTRY

  • Yuvell

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398768 on ClinicalTrials.gov