Perioral WrinklesNCT07398768
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
An observational study of Perioral Wrinkles and Crow's Feet, run by Yuvell at 1 site in Austria.
Trial summary
The goal of this observational study is to learn how a perioral rejuvenation procedure affects perioral line severity and lip volume over time in adults undergoing routine aesthetic treatment in a single clinical center. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioral Wrinkles, Crow's Feet, Lip Volume Enhancement
- What is being tested?
- Saypha® Rich and Saypha® Filler Lidocaine
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteAustria
- Study dates
- 13 Feb 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- 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 static perioral lines and maximum of thin lips, as assessed by the investigator.
- Participant has a stable medical condition with no uncontrolled systemic disease.
- Willingness to participate in the routine follow-up after 12 weeks and a signed ICF.
- Participant already visiting the clinic for the specific treatment.
Who cannot join
- Pregnancy and breast feeding.
- Known impairment of blood coagulation.
- Presence of acute infection or inflammation at the proposed injection sites.
- Hyaluronic Acid-Filler treatment in the perioral 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
YUVELL
Vienna, State of Vienna, 1010
Mia Cajkovsky, +43 1 512 13 25 30, mia.cajkovsky@yuvell.at
Michelle Friedrich, MSc, +43 1 512 13 25 30, michelle.friedrich@yuvell.at
About this study
Official title: A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure
The goal of this observational study is to learn how a perioral rejuvenation procedure affects perioral line severity and lip volume over time in adults undergoing routine aesthetic treatment in a single clinical center. The main questions it aims to answer are:
- What proportion of participants achieves a ≥1-point improvement from baseline on both the Lip Fullness Scale (LFS) and the Static Perioral Lines Assessment Scale (SPLAS) at Week 12?
- How do skin wrinkling/surface roughness, lip and perioral volume, and patient satisfaction change over 6 and 12 weeks?
Read more
Participants will:
- Receive a routine (non-study-mandated) holistic perioral rejuvenation procedure as decided by their treating clinician.
- Attend study visits at approximately baseline, Week 6, and Week 12.
- Undergo independent clinical assessments (assessor not involved in treatment delivery) of LFS and SPLAS.
- Have skin wrinkling and surface roughness documented by VISIA skin analysis (baseline, Week 6, Week 12).
- Have lip and perioral volume measured by VECTRA M3 volume analysis (baseline, Week 6, Week 12).
- Complete a standardized patient satisfaction questionnaire (Week 12).
- Conditions
- Perioral Wrinkles, Crow's Feet, Lip Volume Enhancement, Lip Aging
- Being tested
- Saypha® Rich, Saypha® Filler Lidocaine
- Keywords
- smoker's lines, perioral wrinkles, perioral lines, hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saypha® RichDevice
Also called hyaluronic acid
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® Filler 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12
Proportion of participants achieving a combined responder status, defined as an improvement of at least 1 point from baseline on both perioral line severity and lip fullness at Week 12, as assessed by an independent investigator not involved in treatment procedures, using the following validated photo-numeric scales:
- Upper and lower lip fullness assessed using the Lip Fullness Scale (LFS), a validated 5-point photo-numeric rating scale ranging from Grade 1 (very thin) to Grade 5 (full), where higher scores indicate greater lip fullness. The upper and lower lips are graded separately.
- Static perioral line severity assessed using the Static Perioral Lines Assessment Scale (SPLAS), a photo-numeric scale ranging from 1 (none) to 5 (very severe), where higher scores indicate greater severity of perioral lines.
A participant is considered a responder only if the ≥ 1-point improvement criterion is met on both the LFS and the SPLAS simultaneously relative to baseline.
Measured: Week 12
Secondary outcomes (5)
Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIA® skin analysis
Change from baseline in skin wrinkling and surface roughness of the lips and perioral region, assessed at Week 6 and Week 12 using the VISIA® Skin Analysis System (Canfield).
Skin wrinkling and surface roughness are quantified as percentage-based measurements derived from standardized, high-resolution VISIA images captured frontally and obliquely. For this outcome, values are calculated as the mean percentage from frontal images obtained at each time point.
The outcome is expressed as the change in percentage points relative to baseline, with higher percentage values indicating improvement, corresponding to reduced skin wrinkling and smoother skin surface in the lips and perioral region.
Measured: Week 6, Week 12
Change in combined upper and lower lip fullness assessed by the Lip Fullness Scale (LFS)
Change from baseline in upper and lower lip fullness, assessed at Week 6 and Week 12 by an independent investigator who is not involved in treatment delivery or injection procedures, using the Lip Fullness Scale (LFS).
The LFS is a validated 5-point photo-numeric rating scale ranging from Grade 1 (very thin) to Grade 5 (full), where higher scores indicate greater lip fullness. The upper and lower lips are graded separately, and the assigned grades are recorded at each assessment time point.
The outcome is expressed as the change in LFS score relative to baseline at each follow-up visit, reflecting changes in combined upper and lower lip volume over time.
Measured: Week 6, Week 12
Change in perioral line severity assessed by the Static Perioral Lines Assessment Scale (SPLAS)
Change from baseline in perioral line severity, assessed at Week 6 and Week 12 by an independent investigator who is not involved in treatment delivery or injection procedures, using the Static Perioral Lines Assessment Scale (SPLAS).
The SPLAS is a photo-numeric rating scale ranging from 1 (none) to 5 (very severe), where higher scores indicate greater severity of static perioral lines. The investigator uses the accompanying morphed images and photo atlas to support standardized severity grading at each assessment time point.
The outcome is expressed as the change in SPLAS score relative to baseline, reflecting changes in static perioral line severity over time.
Measured: Week 6, Week 12
Change in lip and perioral volume assessed by three-dimensional (3D) facial imaging
Change from baseline in lip and perioral volume, assessed at Week 6 and Week 12 using three-dimensional (3D) facial imaging acquired with the VECTRA M3 imaging system (Canfield Scientific Inc., Fairfield, New Jersey, USA).
Standardized 3D facial photographs are obtained with participants in an upright sitting position at baseline and follow-up visits. The images are analyzed using the VECTRA Software Suite®, and volume changes in the lips and perioral region are quantified by comparing baseline images with follow-up images captured at Week 6 and Week 12.
The outcome is expressed as the change in volume relative to baseline, reflecting changes in lip and perioral volume over time.
Measured: Week 6, Week 12
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 12
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 start13 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioral WrinklesStudies 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
- 34 participants (estimated)
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
- NCT07398768
- Sponsor's protocol ID
- YUV-NIS-003
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 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 13 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 Perioral Rejuvenation Procedure
- ClinicalTrials.gov ID
- NCT07398768
- Acronym / sponsor ID
- YUV-NIS-003
- Conditions
- Perioral Wrinkles, Crow's Feet, Lip Volume Enhancement, Lip Aging
- Keywords
- smoker's lines, perioral wrinkles, perioral lines, hyaluronic acid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- YuvellUniversity, hospital or other
- Collaborators
- Croma-Pharma GmbH
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- 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 observational study is to learn how a perioral rejuvenation procedure affects perioral line severity and lip volume over time in adults undergoing routine aesthetic treatment in a single clinical center. The main questions it aims to answer are:
- What proportion of participants achieves a ≥1-point improvement from baseline on both the Lip Fullness Scale (LFS) and the Static Perioral Lines Assessment Scale (SPLAS) at Week 12?
- How do skin wrinkling/surface roughness, lip and perioral volume, and patient satisfaction change over 6 and 12 weeks?
Participants will:
- Receive a routine (non-study-mandated) holistic perioral rejuvenation procedure as decided by their treating clinician.
- Attend study visits at approximately baseline, Week 6, and Week 12.
- Undergo independent clinical assessments (assessor not involved in treatment delivery) of LFS and SPLAS.
- Have skin wrinkling and surface roughness documented by VISIA skin analysis (baseline, Week 6, Week 12).
- Have lip and perioral volume measured by VECTRA M3 volume analysis (baseline, Week 6, Week 12).
- Complete a standardized patient satisfaction questionnaire (Week 12).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- 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 (5 listed)
- 18 years or older at time of treatment.
- At least mild static perioral lines and maximum of thin lips, as assessed by the investigator.
- Participant has a stable medical condition with no uncontrolled systemic disease.
- Willingness to participate in the routine follow-up after 12 weeks and a signed ICF.
- Participant already visiting the clinic for the specific treatment.
Key exclusion criteria (6 listed)
- Pregnancy and breast feeding.
- Known impairment of blood coagulation.
- Presence of acute infection or inflammation at the proposed injection sites.
- Hyaluronic Acid-Filler treatment in the perioral area within the last 6 months.
- Patients with a history of autoimmune disease or who are receiving immune therapy.
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 |
|---|---|---|
| Saypha® RichAlso: hyaluronic acidDevice 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® Filler 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 | – |
Primary outcome
Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12
Time frame: Week 12
Proportion of participants achieving a combined responder status, defined as an improvement of at least 1 point from baseline on both perioral line severity and lip fullness at Week 12, as assessed by an independent investigator not involved in treatment procedures, using the following validated photo-numeric scales: * Upper and lower lip fullness assessed using the Lip Fullness Scale (LFS), a validated 5-point photo-numeric rating scale ranging from Grade 1 (very thin) to Grade 5 (full), where higher scores indicate greater lip fullness. The upper and lower lips are graded separately. * Static perioral line severity assessed using the Static Perioral Lines Assessment Scale (SPLAS), a photo-numeric scale ranging from 1 (none) to 5 (very severe), where higher scores indicate greater severity of perioral lines. A participant is considered a responder only if the ≥ 1-point improvement criterion is met on both the LFS and the SPLAS simultaneously relative to baseline.
5 secondary outcomes
Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIA® skin analysis
Time frame: Week 6, Week 12
Change in combined upper and lower lip fullness assessed by the Lip Fullness Scale (LFS)
Time frame: Week 6, Week 12
Change in perioral line severity assessed by the Static Perioral Lines Assessment Scale (SPLAS)
Time frame: Week 6, Week 12
Change in lip and perioral volume assessed by three-dimensional (3D) facial imaging
Time frame: Week 6, Week 12
Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
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 Perioral Wrinkles and Crow's Feet, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia Cajkovsky (+43 1 512 13 25 30, mia.cajkovsky@yuvell.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a combined ≥ 1-point improvement in perioral line severity and lip fullness at Week 12 (time frame: Week 12). 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 13 Mar 2026.