Perioral rejuvenation with hyaluronic acid to reduce perioral lines and restore lip fullness
A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure
This will see if routine perioral rejuvenation injections with hyaluronic acid can increase lip fullness and reduce perioral lines in adults getting aesthetic treatment at a clinic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yuvell Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT07398768 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-interventional observational program enrolling adults who are already planning routine perioral rejuvenation at a single clinic in Vienna. Participants receive whatever holistic perioral procedure their treating clinician chooses, with no additional mandated treatments. Independent assessors will rate lip fullness and static perioral lines and VISIA imaging will document skin wrinkling and surface roughness at baseline, Week 6, and Week 12. The main outcome is the proportion of participants with at least a 1-point improvement on both the Lip Fullness Scale and the Static Perioral Lines Assessment Scale at Week 12, with secondary measures of volume and patient satisfaction over 6 and 12 weeks.
Who should consider this trial
Good fit: Adults aged 18 or older with at least mild static perioral lines and thin lips, a stable medical condition, and who are already planning perioral treatment at the participating clinic are the ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have coagulation impairment, acute infection at injection sites, recent perioral hyaluronic acid within 6 months, autoimmune disease or immune therapy, or a known allergy to hyaluronic acid or lidocaine are excluded and unlikely to be helped by participation.
Why it matters
Potential benefit: If successful, the results could give patients clearer expectations about typical improvements in lip fullness and perioral lines after routine hyaluronic acid procedures.
How similar studies have performed: Hyaluronic acid fillers for lip enhancement and perioral line reduction are well established and prior clinical reports have shown improvements in lip fullness and wrinkle appearance, so this approach is not novel but is being documented in routine practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years or older at time of treatment. 2. At least mild static perioral lines and maximum of thin lips, as assessed by the investigator. 3. Participant has a stable medical condition with no uncontrolled systemic disease. 4. Willingness to participate in the routine follow-up after 12 weeks and a signed ICF. 5. Participant already visiting the clinic for the specific treatment. Exclusion Criteria: 1. Pregnancy and breast feeding. 2. Known impairment of blood coagulation. 3. Presence of acute infection or inflammation at the proposed injection sites. 4. Hyaluronic Acid-Filler treatment in the perioral area within the last 6 months. 5. Patients with a history of autoimmune disease or who are receiving immune therapy. 6. History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amidetype local anaesthetics.
Where this trial is running
Vienna, State of Vienna
- Yuvell — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Mia Cajkovsky
- Email: mia.cajkovsky@yuvell.at
- Phone: +43 1 512 13 25 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.