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Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

NCT07255261 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2025-12-08

No results posted yet for this study

Summary

The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Subjects aged 18 years or older seeking aesthetic treatment of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows may be included. The main question the study aims to answer is: How long does the effect of the products last?

Participants will attend follow-up visits every 6 months after the initial injection, until the end of follow-up at 24 months. During each visit, the investigator will assess performance and safety through a simple clinical examination. At each follow-up visit, subjects will also evaluate the aesthetic improvement compared with their pre-injection appearance. Subjects will be asked about the level of pain experienced during the initial injection.

If the subject wishes, a retreatment may be performed at the 12-month or 18-month follow-up visit, provided that the treated area(s) have returned to the pre-injection state.

Conditions

  • Lips Enhancement
  • Perioral Wrinkles
  • Nasolabial Fold Wrinkles
  • Cheek Augmentation
  • Infraorbital Hollows

Interventions

DEVICE

Facial injection of hyaluronic acid-based dermal fillers.

Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.

Sponsors & Collaborators

  • Symatese

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • France

Study Locations

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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 NCT07255261 on ClinicalTrials.gov