18 and older, any sex, with Nasolabial Fold, Hypoplastic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
NLF-SRS Grade of Nasolabial Folds ChangePrimary· 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
Group
Value
95% CI
Princess® VOLUME Lidocaine
-1.50
± 0.58
NLF-SRS Grade of Nasolabial Folds ReductionPrimary· 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
Group
Value
95% CI
Princess® VOLUME Lidocaine
58
NLF-SRS Grade of Nasolabial Folds Change - Other TimepointsSecondary· 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
Week 4
Group
Value
95% CI
Princess® VOLUME Lidocaine
-1.54
± 0.62
Week 36
Group
Value
95% CI
Princess® VOLUME Lidocaine
-1.35
± 0.66
NLF-SRS Grade of Nasolabial Folds Reduction- Other TimepointsSecondary· 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
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 rate with aesthetic outcome of the treatment at Week 4, Week 24 and Week 36, as evaluated by the subject
Week 4
Group
Value
95% CI
Princess® VOLUME Lidocaine
52
Week 24
Group
Value
95% CI
Princess® VOLUME Lidocaine
48
Week 36
Group
Value
95% CI
Princess® VOLUME Lidocaine
49
Pain IntensitySecondary· 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).
Baseline- Initial Assessment (right after injection)
Group
Value
95% CI
Princess® VOLUME Lidocaine
1.2
± 1.3
Baseline - Second Assessment ( 15 min after injection)
Group
Value
95% CI
Princess® VOLUME Lidocaine
0.1
± 0.4
Baseline - Change from initial assessment to second assessment
Group
Value
95% CI
Princess® VOLUME Lidocaine
-1.0
± 1.1
Week 2 /Touch up - Initial Assessment (right after injection)
Group
Value
95% CI
Princess® VOLUME Lidocaine
1.5
± 0.9
Week 2 /Touch up - Second Assessment ( 15 min after injection)
Group
Value
95% CI
Princess® VOLUME Lidocaine
0.0
± 0.0
Week 2/ touch up - Change from initial assessment to second assessment
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.
Group
Value
95% CI
Princess® VOLUME Lidocaine
60
Safety EventsSecondary· From day 0 until patient last visit / week 36
Occurrence and frequency of adverse events
Adverse Device Effect - Injection site hematoma
Group
Value
95% CI
Princess® VOLUME Lidocaine
1
Adverse Device Effect - Injection site hypoesthesia
Group
Value
95% CI
Princess® VOLUME Lidocaine
6
Adverse Device Effect - Injection site pain
Group
Value
95% CI
Princess® VOLUME Lidocaine
2
Adverse Device Effect - Syncope
Group
Value
95% CI
Princess® VOLUME Lidocaine
1
Influenza
Group
Value
95% CI
Princess® VOLUME Lidocaine
1
Lice Infestation
Group
Value
95% CI
Princess® VOLUME Lidocaine
1
Rhinitis
Group
Value
95% CI
Princess® VOLUME Lidocaine
1
Urinary tract infection
Group
Value
95% CI
Princess® VOLUME Lidocaine
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 36 weeks - Up to 36 weeks after treatment (Day 0).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Croma-Pharma GmbH
Last refreshed: 4 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03050710.