Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure

NCT07398755 | Completed

• 1 other identifier: YUV-NIS-002
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periorbital wrinkles; Facial wrinkles; Midface volume loss; Periorbital rejuvenation; Facial rejuvenation; Aesthetic dermatology

Outcome Measures

Primary Outcomes (1)

• Change in skin wrinkling in periorbital area at Week 8

  Change in the percentage of skin wrinkling in the periorbital area from baseline to Week 8, as assessed using VISIA® skin analysis. Skin wrinkling is quantified as a percentage-based measurement derived from standardized VISIA imaging of the area around the eye. The outcome is expressed as the percent change relative to baseline, with higher percentages indicating an improvement, which equals a reduction in skin wrinkling.

  Week 8

Secondary Outcomes (4)

• Change in skin wrinkling in the periorbital area at Week 22

  Week 22

• Change in severity of dynamic glabellar lines at Week 8 and Week 22

  Week 8, Week 22

• Change from baseline in midface volume deficit severity, assessed at Week 8 and Week 22 by the investigator using the Midface Volume Deficit Severity Score (MVDSS)

  Week 8, Week 22

• Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire

  Week 22

Study Arms (1)

Single Observational Cohort

Participants receiving routine clinical care/undergoing the rejuvenation procedure.

Drug: Letybo®; Device: Philart® Eye; Device: Saypha® Volume Plus Lidocaine

Interventions

Saypha® Volume Plus Lidocaine DEVICE

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.

Also known as: hyaluronic acid with lidocaine

Single Observational Cohort

Letybo® DRUG

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.

Also known as: BoNT/A, botulinum toxin A, Letibotulinumtoxin A

Single Observational Cohort

Philart® Eye DEVICE

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.

Also known as: polynucleotide

Single Observational Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting the clinic for such a treatment as part of routine clinical practice.

You may qualify if:

• years or older at time of treatment.
• At least mild periorbital skin wrinkling, mild frown lines at maximum frown and mild.
• midface volume deficiency as assessed by the investigator
• Subject has a stable medical condition with no uncontrolled systemic disease.
• Willingness to participate in the routine follow-up after 8 weeks and 22 weeks and a signed informed consent form.
• Subject already visiting the clinic for the specific treatment.

You may not qualify if:

• Pregnancy and breast feeding.
• Neuromuscular disease (e.g. myasthenia gravis, Eaton - Lambert syndrome).
• Known impairment of blood coagulation.
• Drooping eyelid.
• Known allergy to botulinum toxin or human albumin (blood protein).
• Presence of acute infection or inflammation at the proposed injection sites.
• Botulinum toxin treatment in the glabella within the last 16 weeks.
• HA- Filler treatment in the midface or periorbital area within the last 6 months.
• Patients with a history of autoimmune disease or who are receiving immune therapy.
• History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amidetype local anaesthetics.
• History of fish product allergy.

Sponsors & Collaborators

• Yuvell: lead
• Croma-Pharma GmbH: collaborator

Study Sites (1)

YUVELL

Vienna, Vienna, 1010, Austria

Location

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 10, 2026
• Study Start: September 2, 2025
• Primary Completion: December 11, 2025
• Study Completion: March 11, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

AU (1)