The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine. The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds. Participants will: Receive 3 rounds of treatment and will be followed up for a total of 2 years.
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine. The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds. Participants will: Receive 3 rounds of treatment and will be followed up for a total of 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Dermal filler (PLLA)
Ribé clinic
Barcelona, Spain
The Faculty
Stockholm, Sweden
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score. Score 1-5, Higher scores are a worse outcome.
Time frame: 12 months after final injection
Percentage of subjects with improvement of at least 1 grade on the WSRS.
Percentage of subjects with an improvement of at least 1 grade on the WSRS of the left and right (mean of the two) NLF at 3, 6 and 24 months after final injection compared to baseline (investigator assessment at all visits, blinded assessment at 12 months).
Time frame: Up to 24 months after final injection
Change in WSRS score
Change in WSRS score of the NLF at 3, 6, 12 and 24 months after final injection compared to baseline. Score 1-5, Higher scores are a worse outcome.
Time frame: Up to 24 months after final injection
Mean WSRS of <2 at each follow-up time
Proportion of subjects with a mean WSRS of \<2 at each follow-up time point at 3, 6, 12, and 24 months after final injection.
Time frame: Up to 24 months after final injection
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.
Time to at least one grade improvement in mean WSRS and time to mean WSRS \<2.
Time frame: Up to 24 months after final injection
Change Face-Q score of Nasolabial Fold
Change in FACE-Q score of the NLF at 6, 12, and 24 months after final injection compared to baseline. Scores 1-4: high scores better outcome
Time frame: Up to 24 months after final injection
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Change in Global Aesthetic in Improvement Scale
Change in Global Aesthetic Improvement Scale (GAIS) scores evaluated by the subject, the investigator and a blinded assessor from 2D facial digital imaging at 6, 12, and 24 months after final injection compared to baseline. Scale 1-5; High scores worse outcome
Time frame: Up to 24 months after final injection
Subject Satisfaction Scores
Assessment of Subject Satisfaction Scores at 6, 12, and 24 months after final injection. Scale 1-5; High scores better outcome
Time frame: Up to 24 months after final injection