The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds
This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial. Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
HA filler
HA filler
Catholic University St. Paul Hospital
Seoul, Dongdaemun-gu, South Korea
Chung-Ang Univ. Medical Center
Seoul, Dongjak-gu, South Korea
Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
Time frame: from baseline to 24 weeks
Change on Wrinkle Severity Rating Scale as evaluated by an investigator
Time frame: from baseline to 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator
Time frame: from baseline to 8, 16, 24 weeks
Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
Time frame: from baseline to 8, 16 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters
Time frame: from baseline to 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator
Time frame: 8, 16, 24 weeks after the injection
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject
Time frame: 8, 16, 24 weeks after the injection
Visual Analogue Scale as evaluated by a subject
Time frame: at 15, 30, 45, 60 minutes after the injection
Vital signs, physical examination, laboratory tests and adverse events
Time frame: from baseline to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.