Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds (VINO)

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.

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold, Hypoplastic
• Intervention / Treatment: Device: Princess® VOLUME Lidocaine

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University Graz
  • Wien, Austria
    • MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
  • Wien, Austria
    • Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female 18 years of age or older
2. 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
3. Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
4. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
5. Written signed and dated informed consent

Exclusion Criteria:

1. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
2. History of mental disorders or emotional instability
3. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
4. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
5. 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
6. Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
7. Cutaneous lesions in the treatment area
8. Known human immune deficiency virus-positive individuals
9. History of allergies against aesthetic filling products and recurrent herpes simplex
10. Tendency to hypertrophic scars and/or keloid formation
11. History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
12. Diabetes mellitus or uncontrolled systemic diseases
13. Use of anticoagulant, antiplatelet or thrombolytic medication from 10 days pre- to 3 days post injection
14. Any medical condition which, in the investigator's opinion. prohibits the inclusion in the study
15. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
16. Previous enrolment in this clinical investigation
17. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Princess® VOLUME Lidocaine; 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

Device: Princess® VOLUME Lidocaine; Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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	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).	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.	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Events	Occurrence and frequency of adverse events	From day 0 until patient last visit / week 36

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2016
• Primary Completion (Actual): July 18, 2017
• Study Completion (Actual): October 17, 2017

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: CPH-401-201258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No