Glabellar LinesNCT07398755
Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure
An observational study of Glabellar Lines and Midface Volume Deficiency, run by Yuvell at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Lines, Midface Volume Deficiency, Periorbital Wrinkling
- What is being tested?
- Letybo®, Philart® Eye and Saypha® Volume Plus Lidocaine
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteAustria
- Study dates
- 2 Sep 2025to 11 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting the clinic for such a treatment as part of routine clinical practice.
Who may be able to join
- 18 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Being tested
- Letybo®, Philart® Eye, Saypha® Volume Plus Lidocaine
- Keywords
- Periorbital wrinkles, Facial wrinkles, Midface volume loss, Periorbital rejuvenation, Facial rejuvenation, Aesthetic dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letybo®Drug
Also called BoNT/A, botulinum toxin A, Letibotulinumtoxin A
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.
Philart® EyeDevice
Also called polynucleotide
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.
Saypha® Volume Plus LidocaineDevice
Also called hyaluronic acid with 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Observational Cohort | Participants receiving routine clinical care/undergoing the rejuvenation procedure. Receives: Drug: Letybo®; Device: Philart® Eye; Device: Saypha® Volume Plus Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start2 Sep 2025
- Primary completion11 Dec 2025
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuvell
- Sponsor type
- University, hospital or other
- Collaborators
- Croma-Pharma GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398755
- Sponsor's protocol ID
- YUV-NIS-002
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Extended Periorbital Rejuvenation Procedure
- ClinicalTrials.gov ID
- NCT07398755
- Acronym / sponsor ID
- YUV-NIS-002
- Keywords
- Periorbital wrinkles, Facial wrinkles, Midface volume loss, Periorbital rejuvenation, Facial rejuvenation, Aesthetic dermatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- YuvellUniversity, hospital or other
- Collaborators
- Croma-Pharma GmbH
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Observational Cohort | – | Drug: Letybo®, Device: Philart® Eye, Device: Saypha® Volume Plus LidocaineParticipants receiving routine clinical care/undergoing the rejuvenation procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the clinic for such a treatment as part of routine clinical practice.
Key inclusion criteria (6 listed)
- 18 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letybo®Also: BoNT/A, botulinum toxin A, Letibotulinumtoxin ADrug is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with drug use. | Drug | Single Observational Cohort |
| Philart® EyeAlso: polynucleotideDevice 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 | Single Observational Cohort |
| Saypha® Volume Plus LidocaineAlso: hyaluronic acid with lidocaineDevice 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 | Single Observational Cohort |
Primary outcome
Change in skin wrinkling in periorbital area at Week 8
Time frame: 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.
4 secondary outcomes
Change in skin wrinkling in the periorbital area at Week 22
Time frame: Week 22
Change in severity of dynamic glabellar lines at Week 8 and Week 22
Time frame: 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)
Time frame: Week 8, Week 22
Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire
Time frame: Week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glabellar Lines and Midface Volume Deficiency, run by Yuvell at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin wrinkling in periorbital area at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.