Clinical Trials Directory

Trials / Completed

CompletedNCT07398755

Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure

A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Extended Periorbital Rejuvenation Procedure

Status
Completed
Phase
Study type
Observational
Enrollment
29 (actual)
Sponsor
Yuvell · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

The goal of this observation is to assess the time course of holistic extended periorbital rejuvenation using botulinum toxin A, cross-linked hyaluronic acid and polynucleotides corresponding to the application in routine practice in adults. It will also document the safety of treatment procedure and patient satisfaction. The main questions it aims to answer are: * How does a holistic extended periorbital rejuvenation procedure using botulinum toxin A, cross-linked hyaluronic acid filler, and polynucleotides change skin wrinkling around the eye area over time (particularly after 8 and 22 weeks)? * How does the treatment affect the severity of dynamic glabellar lines at 8 and 22 weeks? * Does the procedure improve midface volume deficiency after 8 and 22 weeks? * How satisfied are participants with the overall rejuvenation treatment? The investigator will observe the combination treatment of a drug Letybo® and medical devices PhilArt® Eye and Saypha® Volume Plus Lidocaine within their approved indications (non-interventional study, on-label use). The combination treatment aims to rejuvenate and improve the eye area holistically in patients coming routinely to the clinic. Participants will: * take PhilArt® Eye on Week 0 (Baseline), 3 and 6; Saypha® Volume Plus Lidocaine on Week 0 (Baseline); Letybo® on Week 6. * visit the clinic on Week 0 (Baseline), 3, 6, 8 and 22 as per clinical practice for checkups and satisfaction assessment.

Conditions

Interventions

TypeNameDescription
DRUGLetybo®Drug is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with drug use.
DEVICEPhilart® EyeDevice is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use.
DEVICESaypha® Volume Plus LidocaineDevice is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use.

Timeline

Start date
2025-09-02
Primary completion
2025-12-11
Completion
2026-03-11
First posted
2026-02-10
Last updated
2026-03-23

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT07398755. Inclusion in this directory is not an endorsement.