In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER 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
A prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds were treated with Princess® FILLER Lidocaine, and were to return for follow-up assessments 2, 4, 24 and 36 weeks after the initial treatment. A Touch-up treatment may be done at Week 2 after initial treatment, if deemed appropriate by the investigator. The performance of the investigational device 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 initial treatment and in comparison to Day 0) and global aesthetic improvement (4, 24 and 36 weeks after the initial treatment). The subject evaluated pain intensity associated with the treatment (at Day 0 and at Week 2 after initial treatment (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the initial treatment. The safety was evaluated based on occurrence of adverse events, which were collected throughout the investigation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
60
Princess FILLER Lidocaine injection up to 10 ml given to the patients at baseline time point. After 2 week a touch up is given in case to be consider necessary.
MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
Vienna, Austria
Yuvell
Vienna, Austria
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24
Change from baseline in average Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately on the 5-point NLF-SRS then the average of the two sides was used for analysis. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Time frame: Baseline and Week 24
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24
The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Time frame: Week 24
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36
Change from baseline in average Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at weeks 4 and 36 after the initial treatment. The left and right nasolabial folds were graded separately on the 5-point NLF-SRS then the average of the two sides was used for analysis. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Time frame: Baseline, Week 4, Week 36
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36
The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at weeks 4 and 36 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
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Time frame: Week 4, Week 36
Proportion of Subjects With Aesthetic Improvement Based on Investigator Assessment at Weeks 4, 24 and 36
The proportion of subjects with an aesthetic improvement over baseline (subjects who have been rated as "very much improved" or "much improved" or "improved" on both nasolabial folds), based on investigator assessment at weeks 4, 24 and 36 after the initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".
Time frame: Week 4, Week 24, Week 36
Satisfaction of Subjects With Aesthetic Outcome at Weeks 4, 24 and 36
Summary of subjects' satisfaction with aesthetic outcome of the treatment at weeks 4, 24 and 36 after the initial treatment. Subjects were asked to rate their satisfaction with the treatment using one of the following categories: 'very unsatisfied', 'unsatisfied', 'neither unsatisfied nor satisfied', 'satisfied', or 'very satisfied'.
Time frame: Week 4, Week 24, Week 36
Average Pain Intensity Based on Subject Assessment Immediately After the Last Injection and 15 Minutes Thereafter for Initial and Touch-up Treatment
Average pain intensity based on subject assessment immediately after the last injection and about 15 minutes thereafter for initial treatment at baseline and for touch-up treatment at week 2 (if applicable). Subjects quantified the pain associated with the procedure using a semi-quantitative 11-point Numeric Pain Rating Scale (NPRS): 0 is no pain and 10 is the worst pain you can imagine.
Time frame: Baseline - Immediately after end of treatment, 15 minutes after end of treatment Week 2 - Immediately after end of treatment, 15 minutes after end of treatment
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Independent Reviewer Assessment of Photographs at Week 24
The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on independent reviewer assessment of photographs at week 24 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Time frame: Week 24