This Post-Market Clinical Follow-Up (PMCF) survey aims to descriptively evaluate the clinical performance and safety of saypha® filler when used under routine clinical practice for the correction of moderate to severe nasolabial folds (NLFs). The survey is conducted in accordance with the device's Instructions for Use (IFU) and consists of a combined prospective and retrospective, non-interventional, observational design across 1-2 European sites with established experience in aesthetic treatments and standardized documentation practices. The survey will use exclusively real-world clinical data collected during routine care and will not alter, influence, or prescribe any aspect of treatment. The primary objective is to describe changes in NLF severity following treatment with saypha® filler, using a validated 5-graded photonumeric NLF Scale routinely applied in aesthetic practice. Secondary objectives include documenting the maximum volume administered during initial and touch-up treatments, determining the highest administered dose without associated safety concerns, evaluating safety outcomes through the reporting of adverse events (AEs), adverse device effects (ADEs), and device deficiencies (DDs), and describing visible aesthetic changes as assessed by treating physicians at multiple follow-up visits. Additional outcomes include the descriptive summary of aesthetic improvement through the modified Global Aesthetic Improvement Scale (mGAIS) and participant-reported satisfaction, collected where this aligns with site routine. Participants are eligible if they received (or are planned to receive) saypha® filler for moderate to severe NLFs as per the IFU, are ≥18 years old, and provide informed consent for the use of their routine clinical data. Prospective participants will be informed about the survey only after their routine treatment has been completed. Retrospective participants may be included if their treatment occurred within the past six months and sufficient routine documentation exists. Individuals may be included if data are available for at least two follow-up visits within the 6-11-month period post-treatment (corresponding to Visit 3 and Visit 4). Exclusion criteria include concurrent clinical study involvement that may interfere with assessment, prior permanent fillers or recent aesthetic procedures in the treatment area, medically supervised weight-loss programs during follow-up, and pregnancy or breastfeeding due to IFU contraindications. The survey aims to collect evaluable data from 30 participants, with allowance for up to 10% additional participants to compensate for potential dropouts. Each participant contributes data for the left and right NLF, which will be analyzed both separately and combined. This sample size ensures sufficient descriptive precision for key safety and performance outcomes. No hypothesis testing is planned; all analyses will be descriptive, employing summary statistics for categorical and continuous variables. No imputation will be performed for missing data. Data will be collected via standardized Case Report Forms (CRFs) and an electronic data capture (EDC) system, ensuring consistency across sites. Site personnel will be trained on survey procedures and CRF completion. Monitoring activities include periodic data checks to minimize discrepancies and ensure accuracy. Data security measures include pseudonymization, compliance with GDPR, restricted access to authorized personnel, and comprehensive audit trails within the EDC system. Safety information-including adverse events, adverse device effects, and device deficiencies-will be documented according to each site's established clinical practice. The survey does not require any additional visits, diagnostic measures, or procedures beyond routine care. All data derive exclusively from regular clinical documentation already generated through standard treatment pathways. Upon completion of the data collection phase, each site will undergo a closeout to ensure CRF completeness and resolution of outstanding queries. A final report will summarize the descriptive findings related to clinical performance, aesthetic outcomes, and safety of saypha® filler in real-world practice. The final study outcomes will contribute to the device's ongoing post-market clinical evaluation and will support regulatory compliance under the Medical Device Regulation (MDR), Annex XIV, Part B.
Study Type
OBSERVATIONAL
Enrollment
30
Routine clinical use of a cross-linked hyaluronic acid dermal filler administered according to its Instructions for Use (IFU) for the correction of moderate to severe nasolabial folds. The intervention is not assigned by the study team; all treatments are performed independently as part of standard aesthetic practice. The survey collects real-world data on volumes administered, aesthetic outcomes, and safety events following this routine treatment.
Yuvell
Vienna, Austria
Change in nasolabial fold severity on a 5-grade photonumeric scale
Change in the severity of the nasolabial folds (NLFs) from baseline to the 6-month follow-up visit, assessed separately for the right and left NLF using a validated 5-grade photonumeric nasolabial fold severity scale. The scale ranges from 0 = none/minimal to 4 = extreme, with higher scores indicating greater NLF severity (worse outcome). All assessments are performed by the treating physician as part of routine clinical practice. The descriptive analysis summarizes the proportion of participants demonstrating an improvement of at least 1 grade (≥1-grade reduction) in NLF severity at the 6-month follow-up compared with baseline, assessed separately for the right and left NLF.
Time frame: Baseline (Visit 1) to 6 months post-treatment (Visit 3; 6 months ± 14 days)
Maximum volume administered per treatment
Total volume (mL) of saypha® filler administered during the initial and any touch-up treatment, documented separately for the left, right, and combined nasolabial folds. Volumes are derived from routine clinical documentation.
Time frame: At baseline treatment and any touch-up treatment within the 6-11-month follow-up period
Maximum dose administered without safety concerns
Highest administered volume (mL) of saypha® filler that did not result in (1) serious adverse device effects (SADEs) or (2) adverse device effects (ADEs) requiring significant medical intervention (e.g., hyaluronidase dissolution or surgical procedures).
Time frame: During initial and any touch-up treatment within the 6-11-month follow-up period
Incidence of adverse events and adverse device effects
Frequency, type, and severity of adverse events (AEs) and adverse device effects (ADEs) reported during routine clinical practice following treatment with saypha® filler.
Time frame: From treatment day through the entire 6-11-month follow-up period
Visible aesthetic change in nasolabial fold severity
Change in nasolabial fold (NLF) severity assessed separately for the right and left NLF using the validated 5-grade photonumeric Nasolabial Fold Severity Scale. The scale ranges from 0 = none/minimal to 4 = extreme, with higher scores indicating greater NLF severity (worse outcome). All assessments are performed by the treating physician as part of routine clinical practice. The outcome is evaluated at two post-treatment time points (Visit 2 and Visit 4). Results are summarized descriptively separately for each visit, including the proportion of participants demonstrating an improvement of at least 1 grade (≥1-grade reduction) from baseline for the right and left NLF.
Time frame: Visit 2 (Day 14; ±16 days) and Visit 4 (9 months; ±1 month) post-treatment
Aesthetic improvement based on modified GAIS
Proportion of participants rated as "improved" or "much improved" by the treating physician using the modified Global Aesthetic Improvement Scale (mGAIS). Assessments reflect routine clinical practice and are documented as an overall evaluation. The mGAIS is a 5-point ordinal scale with the following categories: 1 = much improved, 2 = improved, 3 = no change, 4 = worse, 5 = much worse, where lower scores indicate greater aesthetic improvement (better outcome). Results are summarized descriptively as the proportion of participants with mGAIS scores of 1 or 2 at each follow-up visit.
Time frame: At all follow-up visits (Visit 2, Visit 3, Visit 4), up to 9-11 months post-treatment
Participant satisfaction with aesthetic outcome
Proportion of participants reporting satisfaction (scores 4-5 on a 5-point scale: 1=Very Unsatisfied, 5=Very Satisfied) with the outcome of saypha® filler treatment. Collected only at sites where satisfaction questionnaires are part of routine practice.
Time frame: At all follow-up visits where participant satisfaction questionnaires are used (up to 9-11 months post-treatment)
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