Nasolabial Fold, HypoplasticVINONCT03050710
Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
A study testing Princess® VOLUME Lidocaine in people with Nasolabial Fold, Hypoplastic, run by Croma-Pharma GmbH at 3 sites in Austria.
Trial summary
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME 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 older
- Conditions the study is for
- Nasolabial Fold, Hypoplastic
- What is being tested?
- Princess® VOLUME Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesAustria
- Study dates
- 27 Dec 2016to 17 Oct 2017
- 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
- No healthy volunteers
- 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 Nasolabial Folds Severity Rating Scale (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
- 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 nonabsorbable sutures (thread), laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months, or chemical peeling within previous 3 months, or planning to undergo such procedures in the treatment area during the study
- Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
Show all 17Show fewer
- 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 and/or keloid formation
- 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 10 days pre- to 3 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
3 sites in 1 country.
Austria3 sites
Medical University Graz
Graz
MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
Vienna
Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch
Vienna
About this study
Official title: A Prospective, Open-label, Multicenter, Post-market Study Evaluating Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME 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
This is a prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME 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. The performance of the investigational device will be 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 treatment and in comparison to Day 0), global aesthetic improvement (4, 24 and 36 weeks after the treatment). The subject will evaluate pain intensity associated with the treatment (at Day 0 and at Week 2 (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the treatment.
The safety will be evaluated based on occurrence of adverse events, which will be collected throughout the investigation.
- Conditions
- Nasolabial Fold, Hypoplastic
- Being tested
- Princess® VOLUME Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Princess® VOLUME LidocaineDevice
Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
| Study group | Role | What they receive |
|---|---|---|
| Princess® VOLUME Lidocaine | Other | Princess® VOLUME Lidocaine is administered by injection into the deep dermis or subcutis. The volume applied depends on the size of the area which requires correction and will be selected by the investigator, but will not exceed 10 mL in total per treatment. A single application, with optional Touch-up treatment after two weeks, if the desired level of correction has not been achieved with the initial applicatio Receives: Device: Princess® VOLUME Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
NLF-SRS Grade of Nasolabial Folds Change
The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator.
The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
Measured: 24 weeks
NLF-SRS Grade of Nasolabial Folds Reduction
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 24 versus baseline.
The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
Measured: 24 weeks
Secondary outcomes (6)
NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints
The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 4 and Week 36 as evaluated by the investigator.
The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
Measured: Week 4, Week 36
NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 4 and week 36 versus baseline
Measured: week 4, week 36
Aesthetic Improvement
The proportion of subjects with aesthetic improvement at Week 4, Week 24 and Week 36, as evaluated by the investigator using the Global Aesthetic Improvement Scale (GAIS)
Measured: week 4, week 24, week 36
Subjects' Satisfaction With Aesthetic Outcome
Subjects' satisfaction rate with aesthetic outcome of the treatment at Week 4, Week 24 and Week 36, as evaluated by the subject
Measured: week 4, week 24, week 36
Pain Intensity
The average pain intensity during and after the treatment, as evaluated by the subject using an 11-point numeric pain rating scale (NPRS), where 0= no pain and 10 = worst pain imaginable, immediately after the last injection and 15 minutes thereafter. Lower scores represent better outcomes (less pain). Higher scores represent worse outcomes (more pain).
Measured: Day 1, Day 15
NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus Baseline at Week 24 as evaluated by the independent reviewer of photographs.
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 posted13 Feb 2017
- Study start27 Dec 2016
- Primary completion18 Jul 2017
- Study completion17 Oct 2017
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 Nasolabial Fold, HypoplasticStudies 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
- Model description
- Princess® VOLUME Lidocaine for the correction of nasolabial folds
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT03050710
- Sponsor's protocol ID
- CPH-401-201258
- Acronym
- VINO
- Status last verified
- Aug 2018
- First submitted
- 9 Feb 2017
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Jun 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® VOLUME Lidocaine for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03050710
- Acronym / sponsor ID
- VINO / CPH-401-201258
- Conditions
- Nasolabial Fold, Hypoplastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 4 Jun 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® VOLUME 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
This is a prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME 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. The performance of the investigational device will be 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 treatment and in comparison to Day 0), global aesthetic improvement (4, 24 and 36 weeks after the treatment). The subject will evaluate pain intensity associated with the treatment (at Day 0 and at Week 2 (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the treatment.
The safety will be evaluated based on occurrence of adverse events, which will be collected throughout the investigation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Princess® VOLUME Lidocaine for the correction of nasolabial folds
| Arm | Type | Receives |
|---|---|---|
| Princess® VOLUME Lidocaine | Other | Device: Princess® VOLUME LidocainePrincess® VOLUME Lidocaine is administered by injection into the deep dermis or subcutis. The volume applied depends on the size of the area which requires correction and will be selected by the investigator, but will not exceed 10 mL in total per treatment. A single application, with optional Touch-up treatment after two weeks, if the desired level of correction has not been achieved with the initial applicatio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 Nasolabial Folds Severity Rating Scale (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 (17 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 nonabsorbable sutures (thread), laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months, or chemical peeling within previous 3 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® VOLUME LidocainePrincess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable | Device | Princess® VOLUME Lidocaine |
Primary outcome
NLF-SRS Grade of Nasolabial Folds Change
Time frame: 24 weeks
The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
NLF-SRS Grade of Nasolabial Folds Reduction
Time frame: 24 weeks
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 24 versus baseline. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
6 secondary outcomes
NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints
Time frame: Week 4, Week 36
NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints
Time frame: week 4, week 36
Aesthetic Improvement
Time frame: week 4, week 24, week 36
Subjects' Satisfaction With Aesthetic Outcome
Time frame: week 4, week 24, week 36
Pain Intensity
Time frame: Day 1, Day 15
NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer
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 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Princess® VOLUME Lidocaine in people with Nasolabial Fold, Hypoplastic, run by Croma-Pharma GmbH at 3 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 17 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 4 Jun 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?
NLF-SRS Grade of Nasolabial Folds Change (time frame: 24 weeks). 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 4 Jun 2025.