Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

Not Applicable

Completed

• Conditions: Nasolabial Fold, Hypoplastic

• Registration Number: NCT03050710
• Lead Sponsor: Croma-Pharma GmbH

Brief 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.

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 Timeline

• Study Start: 2016-12-27
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-13
• Primary Completion: 2017-07-18
• Study Completion: 2017-10-17
• Status Verified: 2018-08
• Results First Submitted: 2025-01-27
• Results First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Results First Posted: 2025-06-04
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
NLF-SRS Grade of Nasolabial Folds Change	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	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

Secondary Outcome Measures

Name	Time	Method
NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints	Week 4, Week 36	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
NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints	week 4, week 36	The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 4 and week 36 versus baseline
Aesthetic Improvement	week 4, week 24, week 36	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)
Subjects' Satisfaction With Aesthetic Outcome	week 4, week 24, week 36	Subjects' satisfaction rate with aesthetic outcome of the treatment at Week 4, Week 24 and Week 36, as evaluated by the subject
Pain Intensity	Day 1, Day 15	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).
NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer	Week 24	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.

Trial Locations

Locations (3)

Medical University Graz; 🇦🇹 Graz, Austria

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien; 🇦🇹 Wien, Austria

Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch; 🇦🇹 Wien, Austria