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Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure

NCT07398755 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2026-03-23

No results posted yet for this study

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

  • Glabellar Lines
  • Midface Volume Deficiency
  • Periorbital Wrinkling

Interventions

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.

Sponsors & Collaborators

  • Croma-Pharma GmbH

    collaborator INDUSTRY

  • Yuvell

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2025-12-11
Completion
2026-03-11

Countries

  • Austria

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 NCT07398755 on ClinicalTrials.gov