Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

NCT07398768 | Recruiting

• 1 other identifier: YUV-NIS-003
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Perioral Wrinkles; Crow's Feet; Lip Volume Enhancement; Lip Aging

Keywords

smoker's lines; perioral wrinkles; perioral lines; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (5)

• Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIA® skin analysis

  Week 6, Week 12

• Change in combined upper and lower lip fullness assessed by the Lip Fullness Scale (LFS)

  Week 6, Week 12

• Change in perioral line severity assessed by the Static Perioral Lines Assessment Scale (SPLAS)

  Week 6, Week 12

• Change in lip and perioral volume assessed by three-dimensional (3D) facial imaging

  Week 6, Week 12

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

  Week 12

Interventions

Saypha® Rich 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

Saypha® Filler 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

Eligibility Criteria

• Age: 18 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuvell: lead
• Croma-Pharma GmbH: collaborator

Study Sites (1)

YUVELL

Vienna, Vienna, 1010, Austria

RECRUITING

Central Study Contacts

Mia Cajkovsky

CONTACT

+43 1 512 13 25 30; mia.cajkovsky@yuvell.at

Michelle Friedrich, MSc

CONTACT

+43 1 512 13 25 30; michelle.friedrich@yuvell.at

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: February 13, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

AU (1)