This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subeject diary and follow up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
69
The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.
Samsung Medical Center
Seoul, Gangnam, South Korea
Seoul National University Bundang Hospital
Seongnam, Gyunggi, South Korea
WSRS
The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment
Time frame: 24 weeks after the injection
WSRS
The change between baseline and 2, 8, 16, 24 week WSRS evaluated by the investigator in charge of photographic assessment
Time frame: 2, 8, 16, 24 weeks after the injection
WSRS
The change between baseline and 2, 8, 16 week WSRS evaluated by the investigator in charge of live assessment
Time frame: 2, 8, 16 weeks after the injection
GAIS
The rate of subjects whose GAIS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks from the injection
Time frame: 2, 8, 16, 24 weeks after the injection
GAIS
The rate of subjects whose GAIS, evaluated by the subjects him/herselves, is 1 point or above after 2, 8, 16, 24 weeks from the injection
Time frame: 2, 8, 16, 24 weeks after the injection
WSRS
The rate of subjects whose change of WSRS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks of the injection
Time frame: 2, 8, 16, 24 weeks after the injection
WSRS
The rate of subjects whose change of WSRS, evaluated by the investigator in charge of photographic assessment, is 1 pointe or above after 2, 8, 16, 24 weeks of the injection
Time frame: 2, 8, 16, 24 weeks after the injection
Number of adverse events in subjects
Adverse events occured after informed consent, Adverse drug events, Serious adverse events, lab test, physical examination, vital signs
Time frame: Up to 24 weeks
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