Clinical Trial

Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

Recruiting
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Record status
This record was last updated March 13, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-02.
Status change: Not Yet Recruiting → Recruiting 2026-03-12
Trial Details
NCT Number NCT07398768
Lead Sponsor Yuvell
Collaborators: Croma-Pharma GmbH
Conditions Perioral Wrinkles, Crow's Feet, Lip Volume Enhancement, Lip Aging
Enrollment 34 participants
Start Date 2026-02-13
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-13