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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
62
Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
Medical University Graz
Graz, Austria
MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
Vienna, Austria
Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch
Vienna, Austria
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
Time frame: 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
Time frame: 24 weeks
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
Time frame: 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
Time frame: 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)
Time frame: week 4, week 24, week 36
Subjects' Satisfaction With Aesthetic Outcome
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Subjects' satisfaction rate with aesthetic outcome of the treatment at Week 4, Week 24 and Week 36, as evaluated by the subject
Time frame: 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).
Time frame: 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.
Time frame: Week 24