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

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Lines; Midface Volume Deficiency; Periorbital Wrinkling
• Intervention / Treatment: Drug: Letybo®; Device: Philart® Eye; Device: Saypha® Volume Plus Lidocaine

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Austria
  • Vienna
    • Vienna, Vienna, Austria, 1010
      • YUVELL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 18 years or older at time of treatment.

2. At least mild periorbital skin wrinkling, mild frown lines at maximum frown and mild.

   midface volume deficiency as assessed by the investigator

3. Subject has a stable medical condition with no uncontrolled systemic disease.
4. Willingness to participate in the routine follow-up after 8 weeks and 22 weeks and a signed informed consent form.
5. Subject already visiting the clinic for the specific treatment.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single Observational Cohort; Participants receiving routine clinical care/undergoing the rejuvenation procedure.

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.; Other Names: botulinum toxin A; BoNT/A; Letibotulinumtoxin A; 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.; Other Names: polynucleotide; 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.; Other Names: hyaluronic acid with lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin wrinkling in the periorbital area at Week 22	Change in the percentage of skin wrinkling in the periorbital area from baseline to Week 22, 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 22
Change in severity of dynamic glabellar lines at Week 8 and Week 22	Change from baseline in everuty of glabellar lines at maximum frowning, measured at Week 8 and Week 22 using using the Facial Wrinkle Score (FWS). Severity of glabellar lines is quantified by comparing FWS scores at baseline and follow-up visits to assess severity grade during maximum frowning. The Facial Wrinkle Scale (FWS) is a validated photo-numeric scale ranging from 0 to 3, where higher scores indicate greater wrinkle severity.	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)	Change in investigator-assessed Midface Volume Deficit Severity Score (MVDSS) from baseline to Week 8. The MVDSS is used to evaluate the degree of midface volume deficiency based on clinical assessment. The outcome is expressed as the change in MVDSS score relative to baseline at each follow-up time point, with lower scores indicating a reduction in midface volume deficit severity. The Midface Volume Deficit Scale is a validated 5-point rating photo-numeric scale ranging from grade 0 to grade 4, where higher scores indicate greater very severe volume deficit.	Week 8, Week 22
Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire	Patient satisfaction with the treatment as assessed by participants using the clinic-internal questionnaire titled "Patient Satisfaction Questionnaire". The questionnaire consists of 5 questions evaluating the participant's overall satisfaction with the treatment outcome. Each item is rated on a numeric ordinal scale from 1 to 5, where lower scores indicate higher patient satisfaction.	Week 22

Collaborators and Investigators

• Sponsor: Yuvell
• Collaborators: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Actual): December 11, 2025
• Study Completion (Actual): March 11, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Facial wrinkles; Periorbital wrinkles; Facial rejuvenation; Aesthetic dermatology; Periorbital rejuvenation; Midface volume loss
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; incobotulinumtoxinA
• Other Study ID Numbers: YUV-NIS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No