New study checks safety of popular wrinkle filler
NCT ID NCT07475455
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study followed 30 adults who received saypha® filler injections for moderate to severe smile lines (nasolabial folds) as part of their normal care. Researchers measured how much the lines improved using a standard 5-point scale and tracked any side effects. The goal was to see how well the filler works and how safe it is in everyday use.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Feb 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.
Who is studied
Participants are adults (≥18 years) who received routine clinical treatment with a hyaluronic acid dermal filler for the correction of moderate to severe nasolabial folds. The population includes both prospective participants, who consent after completion of their routine treatment, and retrospective participants whose treatment occurred within the last 6 months and whose routine clinical data are available. Individuals must have at least two documented follow-up visits within 6-11 months post-treatment or be willing to attend such visits. Data derive exclusively from routine clinical practice, including physician-assessed NLF severity, aesthetic improvement ratings, administered volumes, and safety outcomes.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: 1. Individuals treated or planned to be treated with saypha® filler for moderate to severe nasolabial folds as per IFU. 2. Individuals 18 years of age or older. 3. Individuals who have provided consent for use of their data, either prospectively before, at their first visit, or retrospectively at any point during or after the follow up period. 4. Individuals who are willing to have at least two visits within the surveys' 6 to 11-months period or have already completed the follow-up visits and data are available for at least two visits within the survey's 6 to 11-month period, corresponding to Visit 3 and Visit 4. 5. For retrospective included Individuals who have data available on a 5 grade, validated photo numeric NLF scale and the modified GAIS at baseline and for at least two visits within the survey's 6 to 11-month period, corresponding to Visit 3 and Visit 4, or individuals who are willing to attend any follow-up visit with data collected independently for the left and right nasolabial fold (requiring two assessments each per visit). Exclusion Criteria: 1. Individuals involved in other clinical studies that may interfere with the assessment of this device's performance or safety. 2. Individuals with facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) in the area of device application. 3. Individuals that have an implantation of absorbable and non-absorbable facial dermal fillers in the treatment area in the preceding twelve months. 4. Individuals where the skin of the nasolabial region is affected by aesthetic treatments (e.g. laser therapy, absorbable and non-absorbable sutures (threads), microneedling and/or botulinum toxin within the last twelve months, dermabrasion and mesotherapy within the last six months, chemical peeling within the last three months) or planning to undergo such procedures during the survey period. 5. Individuals who had facial lipolysis, including submental fat treatments, within last month prior to enrollment and during the survey period. 6. Individuals currently undergoing a medically supervised or self-initiated diet program aimed at significant weight loss or metabolic change at the time of treatment and/or during the follow-up period. 7. Pregnant or breastfeeding women, as treatment during pregnancy or lactation is contraindicated according to the product's Instructions for Use (IFU).
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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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Yuvell
Vienna, 1010, Austria
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