Trial Outcomes & Findings for Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds (NCT NCT03611491)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2025-03-18

Participant Flow

Unit of analysis: Nasolabial Folds

Participant milestones

Participant milestones
Measure	Princess® FILLER Lidocaine Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point Princess FILLER Lidocaine: 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.
Overall Study STARTED	60 120
Overall Study COMPLETED	59 118
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Princess® FILLER Lidocaine Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point Princess FILLER Lidocaine: 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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Princess® FILLER Lidocaine n=120 Nasolabial Fold Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point Princess FILLER Lidocaine: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	55.3 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Austria	60 participants n=5 Participants
Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade by Investigator	2.72 score on a scale STANDARD_DEVIATION 0.44 • n=120 Nasolabial Fold

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: The population used consists of all participants who received the investigational device and had at least one post-treatment assessment (e.g., first pain assessment after injection). Only subjects with available data for week 24 were included in the analysis.

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).

Outcome measures

Outcome measures
Measure	Princess® FILLER Lidocaine n=118 Nasolabial Fold Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point Princess FILLER Lidocaine: 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 considered necessary.
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24	-1.8 score on a scale Standard Error 0.6

PRIMARY outcome

Timeframe: Week 24

Population: The population consists of all participants who received the investigational device and had at least one post-treatment assessment (e.g., first pain assessment after injection).

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).

Outcome measures

Outcome measures
Measure	Princess® FILLER Lidocaine n=60 Participants Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point Princess FILLER Lidocaine: 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 considered necessary.
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24	58 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 36

Population: The population used consists of all participants who received the investigational device and had at least one post-treatment assessment (e.g., first pain assessment after injection). Only subjects with available data for the respective visit were included in the analysis.

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).