Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults. Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine) Population: Number of subject 100 \* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
Seoul National University Hospital
Seoul, Jongnogu, South Korea
Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device
Descriptive statistics (number of observed subjects, mean, standard deviation, median, minimum, and maximum) for WSRS scores assessed by independent evaluators at 24 weeks after clinical trial device application by treatment group are presented. If the upper limit of the 97.5% one-sided confidence interval by t-distribution is less than 0.29 for the difference between treatment groups (test-control), it is judged that the non-inferiority of the test group has been demonstrated compared to the control group. WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
Time frame: 24 weeks
Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application
Descriptive statistics of WSRS scores (number of observed subjects, mean, standard deviation, median, minimum, and maximum) evaluated by test subjects at 8, 16, 24, and 48 weeks after medical device application for each treatment group are presented and analyzed by Wilcoxon's rank sum test if there is a difference between the administration groups. WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
Time frame: 8, 16, 24, 48 weeks
Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application
Descriptive statistics of GAIS scores (number of observed subjects, mean, standard deviation, median, minimum, and maximum values) evaluated by test subjects at 8, 16, 24, and 48 weeks after medical device application are presented for each treatment group and analyzed by Wilcoxon's rank sum test if there is a difference between the administration groups. GAIS is satisfaction with device usage from a minimum of 0 to a maximum of 5 points, and the higher the score, the higher the satisfaction.
Time frame: 8, 16, 24, 48 weeks
Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application.
Descriptive statistics of WSRS scores (number of observed subjects, mean, standard deviation, median, minimum, and maximum) evaluated by test subjects at 8, 16, 24, and 48 weeks after medical device application for each treatment group are presented and analyzed by Wilcoxon's rank sum test if there is a difference between the administration groups. WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
Time frame: 48 weeks
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