Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07398768
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Sponsor:
Yuvell
Organization:
Study Overview
Official Title:
A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
* 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: