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
| Type | Name | Description |
|---|---|---|
| DRUG | Letybo® | 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. |
| DEVICE | Philart® Eye | Device is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use. |
| DEVICE | Saypha® Volume Plus Lidocaine | Device 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.