New filler study aims to smooth smile lines
NCT ID NCT06471933
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a CE-marked injectable filler (Juläine) for nasolabial fold wrinkles (smile lines). About 59 adults with moderate to deep wrinkles will receive 3 treatments and be followed for 2 years. The main goal is to see if the filler improves wrinkle severity by at least one grade on a standard scale.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 59 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed Informed Consent Form * Male or female, ≥18 years old. * Immune-competent individuals. * Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face. Exclusion Criteria: * Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers). * Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch. * Pigmentation in NLF or having a history of hypo melanosis. * Susceptibility to keloid formation or hypertrophic scarring. * History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate). * History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease. * Hemorrhagic disease or receiving anti-coagulant therapy. * Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events. * Having received in the past 2 months immunosuppressant or systemic steroid therapy. * Having any disease that may affect wound healing, such as connective tissue disorder or serious malnutrition. * Female who is pregnant and/or lactating * Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ribé clinic
Barcelona, Spain
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The Faculty
Stockholm, Sweden
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