Clinical Trial

Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure

Completed
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-02; most recent amendment 2026-03-20.
Status change: Active, Not Recruiting → Completed 2026-03-12
Trial Details
NCT Number NCT07398755
Lead Sponsor Yuvell
Collaborators: Croma-Pharma GmbH
Conditions Glabellar Lines, Midface Volume Deficiency, Periorbital Wrinkling
Enrollment 29 participants
Start Date 2025-09-02
Primary Completion 2025-12-11 (estimated)
Study Completion 2026-03-11 (estimated)
Updated on ClinicalTrials.gov 2026-03-23