N/A
N=62
Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
Nasolabial Fold, Hypoplastic
Bottom Line
View on ClinicalTrials.gov: NCT03050710 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: NLF-SRS Grade of Nasolabial Folds Change — -1.50 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Princess® VOLUME Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Croma-Pharma GmbH
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NLF-SRS Grade of Nasolabial Folds Change |
-1.50 | — |
| PRIMARY NLF-SRS Grade of Nasolabial Folds Reduction |
58 | — |
| SECONDARY NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints |
-1.54; -1.35 | — |
| SECONDARY NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints |
58; 54 | — |
| SECONDARY Aesthetic Improvement |
61; 58; 58 | — |
| SECONDARY Subjects' Satisfaction With Aesthetic Outcome |
52; 48; 49 | — |
| SECONDARY Pain Intensity |
1.2; 0.1; -1.0; 1.5; 0.0; -1.5 | — |
| SECONDARY NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer |
60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT03050710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.