Correction of Nasolabial FoldsFINONCT03611491
Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds
A study testing Princess FILLER Lidocaine in people with Correction of Nasolabial Folds, run by Croma-Pharma GmbH at 2 sites in Austria.
Trial summary
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Correction of Nasolabial Folds
- What is being tested?
- Princess FILLER Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesAustria
- Study dates
- 20 Sep 2017to 19 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older
- Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored 2-3 according to the 5-grade NLF-SRS as assessed by the investigator
- Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
- Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
- Written signed and dated informed consent
Who cannot join
- Subjects meeting any of the following criteria should not be enrolled:
- Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
- History of mental disorders or emotional instability
- History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
- Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
- Facial surgery or implantation of dermal fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, or botulinum toxin application in the nasolabial region within previous twelve months, or chemical peeling within previous three months, or planning to undergo such procedures in the treatment area during the study
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- Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
- Cutaneous lesions in the treatment area
- Known human immune deficiency virus-positive individuals
- History of allergies against aesthetic filling products and recurrent herpes simplex
- Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders
- History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
- Diabetes mellitus or uncontrolled systemic diseases
- Use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
- Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
- Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
- Previous enrolment in this clinical investigation
- Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
Vienna, 1010
Yuvell
Vienna, 1010
About this study
Official title: A Prospective, Open Label, Multicenter, Post Market Study Evaluating Princess® FILLER Lidocaine for the Correction of Nasolabial Folds
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator
Read the detailed description
A prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds were treated with Princess® FILLER Lidocaine, and were to return for follow-up assessments 2, 4, 24 and 36 weeks after the initial treatment. A Touch-up treatment may be done at Week 2 after initial treatment, if deemed appropriate by the investigator. The performance of the investigational device evaluated by the investigator by assessing severity of nasolabial folds using the Nasolabial Folds Severity Rating Scale (NLF-SRS) (4, 24 and 36 weeks after the initial treatment and in comparison to Day 0) and global aesthetic improvement (4, 24 and 36 weeks after the initial treatment). The subject evaluated pain intensity associated with the treatment (at Day 0 and at Week 2 after initial treatment (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the initial treatment.
The safety was evaluated based on occurrence of adverse events, which were collected throughout the investigation.
- Conditions
- Correction of Nasolabial Folds
- Being tested
- Princess FILLER Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Princess FILLER LidocaineDevice
Princess FILLER Lidocaine injection up to 10 ml given to the patients at baseline time point. After 2 week a touch up is given in case to be consider necessary.
| Study group | Role | What they receive |
|---|---|---|
| Princess® FILLER Lidocaine | Experimental | Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point Receives: Device: Princess FILLER Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24
Change from baseline in average Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately on the 5-point NLF-SRS then the average of the two sides was used for analysis. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Measured: Baseline and Week 24
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24
The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Measured: Week 24
Secondary outcomes (6)
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36
Change from baseline in average Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at weeks 4 and 36 after the initial treatment. The left and right nasolabial folds were graded separately on the 5-point NLF-SRS then the average of the two sides was used for analysis. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Measured: Baseline, Week 4, Week 36
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36
The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at weeks 4 and 36 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Measured: Week 4, Week 36
Proportion of Subjects With Aesthetic Improvement Based on Investigator Assessment at Weeks 4, 24 and 36
The proportion of subjects with an aesthetic improvement over baseline (subjects who have been rated as "very much improved" or "much improved" or "improved" on both nasolabial folds), based on investigator assessment at weeks 4, 24 and 36 after the initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".
Measured: Week 4, Week 24, Week 36
Satisfaction of Subjects With Aesthetic Outcome at Weeks 4, 24 and 36
Summary of subjects' satisfaction with aesthetic outcome of the treatment at weeks 4, 24 and 36 after the initial treatment. Subjects were asked to rate their satisfaction with the treatment using one of the following categories: 'very unsatisfied', 'unsatisfied', 'neither unsatisfied nor satisfied', 'satisfied', or 'very satisfied'.
Measured: Week 4, Week 24, Week 36
Average Pain Intensity Based on Subject Assessment Immediately After the Last Injection and 15 Minutes Thereafter for Initial and Touch-up Treatment
Average pain intensity based on subject assessment immediately after the last injection and about 15 minutes thereafter for initial treatment at baseline and for touch-up treatment at week 2 (if applicable). Subjects quantified the pain associated with the procedure using a semi-quantitative 11-point Numeric Pain Rating Scale (NPRS): 0 is no pain and 10 is the worst pain you can imagine.
Measured: Baseline - Immediately after end of treatment, 15 minutes after end of treatment Week 2 - Immediately after end of treatment, 15 minutes after end of treatment
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Independent Reviewer Assessment of Photographs at Week 24
The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on independent reviewer assessment of photographs at week 24 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start20 Sep 2017
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Correction of Nasolabial FoldsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611491
- Sponsor's protocol ID
- CPH-401-201324
- Acronym
- FINO
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2017
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Multicenter, Post Market Study Evaluating Princess® FILLER Lidocaine for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03611491
- Acronym / sponsor ID
- FINO / CPH-401-201324
- Conditions
- Correction of Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator
Detailed description
A prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds were treated with Princess® FILLER Lidocaine, and were to return for follow-up assessments 2, 4, 24 and 36 weeks after the initial treatment. A Touch-up treatment may be done at Week 2 after initial treatment, if deemed appropriate by the investigator. The performance of the investigational device evaluated by the investigator by assessing severity of nasolabial folds using the Nasolabial Folds Severity Rating Scale (NLF-SRS) (4, 24 and 36 weeks after the initial treatment and in comparison to Day 0) and global aesthetic improvement (4, 24 and 36 weeks after the initial treatment). The subject evaluated pain intensity associated with the treatment (at Day 0 and at Week 2 after initial treatment (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the initial treatment.
The safety was evaluated based on occurrence of adverse events, which were collected throughout the investigation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Princess® FILLER Lidocaine | Experimental | Device: Princess FILLER LidocainePrincess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female 18 years of age or older
- Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored 2-3 according to the 5-grade NLF-SRS as assessed by the investigator
- Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
- Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
- Written signed and dated informed consent
Key exclusion criteria (18 listed)
- Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
- History of mental disorders or emotional instability
- History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
- Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
- Facial surgery or implantation of dermal fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, or botulinum toxin application in the nasolabial region within previous twelve months, or chemical peeling within previous three months, or planning to undergo such procedures in the treatment area during the study
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 |
|---|---|---|
| Princess FILLER LidocainePrincess FILLER Lidocaine injection up to 10 ml given to the patients at baseline time point. After 2 week a touch up is given in case to be consider necessary. | Device | Princess® FILLER Lidocaine |
Primary outcome
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24
Time frame: Baseline and Week 24
Change from baseline in average Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately on the 5-point NLF-SRS then the average of the two sides was used for analysis. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24
Time frame: Week 24
The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
6 secondary outcomes
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36
Time frame: Baseline, Week 4, Week 36
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36
Time frame: Week 4, Week 36
Proportion of Subjects With Aesthetic Improvement Based on Investigator Assessment at Weeks 4, 24 and 36
Time frame: Week 4, Week 24, Week 36
Satisfaction of Subjects With Aesthetic Outcome at Weeks 4, 24 and 36
Time frame: Week 4, Week 24, Week 36
Average Pain Intensity Based on Subject Assessment Immediately After the Last Injection and 15 Minutes Thereafter for Initial and Touch-up Treatment
Time frame: Baseline - Immediately after end of treatment, 15 minutes after end of treatment Week 2 - Immediately after end of treatment, 15 minutes after end of treatment
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Independent Reviewer Assessment of Photographs at Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Princess FILLER Lidocaine in people with Correction of Nasolabial Folds, run by Croma-Pharma GmbH at 2 sites 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 18 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: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. 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 18 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.