Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07398768
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).
Study:
NCT07398768
Study Brief:
Protocol Section:
NCT07398768