Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Initial injection of HLR-1 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL.
Initial injection of HLR-2 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL per NLF.
Initial injection of HLR-3 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 4mL per cheek.
Rosenpark Research GmbH
Darmstadt, Germany
Private Practice Dr.Hilton & Partner GbR
Düsseldorf, Germany
Centrum Medyczne Evimed
Warsaw, Poland
Responder Rate
Improvement measured by the responders rate, with a responder defined as a score improved by at least one grade from baseline, i.e. pre-treatment, as determined by the Investigator Live-Evaluator (ILE) using the relevant photo-numerical scale: ROSSI to evaluate the lip volume deficit for subjects in group 1 (scores between 1 and 5 including half scores with higher scores representing fuller lip), Wrinkle Severity Rating Scale (WSRS) for subjects in group 2 (scores between 1 and 5 where higher score represents more pronounced NLF), and Mid-Face Volume Deficit Scale (MFVDS) for subjects in group 3 (scores between 0 and 5 with lower scores representing less volume deficit).
Time frame: Month 3 for Group 1, Month 6 for Groups 2 and 3
Aesthetic Improvement Based on Global Aesthetic Improvement Scale (GAIS) Subject and Investigator
GAIS is evaluated at Week 2 visit, Month 1, Month 3, Month 6, Month 9, Month 12
Time frame: Month 12
Subject's Satisfaction Based on FACE-Q
FACE-Q Satisfaction with Lips for Group 1, FACE-Q Appraisal of Lines: Nasolabial Folds, FACE-Q Satisfaction with Cheeks evaluated at Week 2 visit, Month 1, Month 3, Month 6, Month 9, Month 12
Time frame: Month 12
Performance Based on ILE Scores Compared to Baseline
ILE Scoring on the relevant photo-numerical scale
Time frame: Month 12
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