Wrinkle ReductionFIPSNCT07475455
Filler Post Market Survey (FIPS)
An observational study of Wrinkle Reduction, run by Croma-Pharma GmbH at 1 site in Austria.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrinkle Reduction
- What is being tested?
- Hyaluronic acid dermal filler (routine clinical use)
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 22 Dec 2025to 15 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Individuals treated or planned to be treated with saypha® filler for moderate to severe nasolabial folds as per IFU.
- Individuals 18 years of age or older.
- 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.
- 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.
- 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).
Who cannot join
- Individuals involved in other clinical studies that may interfere with the assessment of this device's performance or safety.
- Individuals with facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) in the area of device application.
- Individuals that have an implantation of absorbable and non-absorbable facial dermal fillers in the treatment area in the preceding twelve months.
- 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.
- Individuals who had facial lipolysis, including submental fat treatments, within last month prior to enrollment and during the survey period.
- 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.
- Pregnant or breastfeeding women, as treatment during pregnancy or lactation is contraindicated according to the product's Instructions for Use (IFU).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PMCF Survey Descriptively Assessing the Clinical Performance and Safety of Saypha® Filler in the Correction of Moderate to Severe Nasolabial Folds.
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.
Read more
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.
- Conditions
- Wrinkle Reduction
- Being tested
- Hyaluronic acid dermal filler (routine clinical use)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid dermal filler (routine clinical use)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with saypha® filler for nasolabial fold correction | Participants who received routine clinical treatment of moderate to severe nasolabial folds using saypha® filler. Data will be collected prospectively after treatment and retrospectively from existing medical records. No study-specific interventions are performed; all assessments derive from standard clinical practice, including NLF severity scores, aesthetic improvement ratings, administered volumes, and safety outcomes. Receives: Device: Hyaluronic acid dermal filler (routine clinical use) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 1) to 6 months post-treatment (Visit 3; 6 months ± 14 days)
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At all follow-up visits where participant satisfaction questionnaires are used (up to 9-11 months post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start22 Dec 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkle ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475455
- Sponsor's protocol ID
- CPH-40602
- Acronym
- FIPS
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PMCF Survey Descriptively Assessing the Clinical Performance and Safety of Saypha® Filler in the Correction of Moderate to Severe Nasolabial Folds.
- ClinicalTrials.gov ID
- NCT07475455
- Acronym / sponsor ID
- FIPS / CPH-40602
- Conditions
- Wrinkle Reduction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants treated with saypha® filler for nasolabial fold correction | – | Device: Hyaluronic acid dermal filler (routine clinical use)Participants who received routine clinical treatment of moderate to severe nasolabial folds using saypha® filler. Data will be collected prospectively after treatment and retrospectively from existing medical records. No study-specific interventions are performed; all assessments derive from standard clinical practice, including NLF severity scores, aesthetic improvement ratings, administered volumes, and safety outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Individuals treated or planned to be treated with saypha® filler for moderate to severe nasolabial folds as per IFU.
- Individuals 18 years of age or older.
- 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.
- 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.
- 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).
Key exclusion criteria (7 listed)
- Individuals involved in other clinical studies that may interfere with the assessment of this device's performance or safety.
- Individuals with facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) in the area of device application.
- Individuals that have an implantation of absorbable and non-absorbable facial dermal fillers in the treatment area in the preceding twelve months.
- 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.
- Individuals who had facial lipolysis, including submental fat treatments, within last month prior to enrollment and during the survey period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid dermal filler (routine clinical use)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. | Device | Participants treated with saypha® filler for nasolabial fold correction |
Primary outcome
Change in nasolabial fold severity on a 5-grade photonumeric scale
Time frame: Baseline (Visit 1) to 6 months post-treatment (Visit 3; 6 months ± 14 days)
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.
6 secondary outcomes
Maximum volume administered per treatment
Time frame: At baseline treatment and any touch-up treatment within the 6-11-month follow-up period
Maximum dose administered without safety concerns
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
Time frame: From treatment day through the entire 6-11-month follow-up period
Visible aesthetic change in nasolabial fold severity
Time frame: Visit 2 (Day 14; ±16 days) and Visit 4 (9 months; ±1 month) post-treatment
Aesthetic improvement based on modified GAIS
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
Time frame: At all follow-up visits where participant satisfaction questionnaires are used (up to 9-11 months post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkle Reduction, run by Croma-Pharma GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nasolabial fold severity on a 5-grade photonumeric scale (time frame: Baseline (Visit 1) to 6 months post-treatment (Visit 3; 6 months ± 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.