\- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial
* Subjects:Adults with nasolabial fold * Investigational Devices: Study Device: SkinPlus-Hyal® Comparator Device: Restylane® \- Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.
The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.
Seoul national university Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
The change in WSRS of the test group and control group
The change in WSRS of the test group and control group from baseline at 24 weeks as assessed by the Investigator in charge of photographic assessment
Time frame: Baseline and 24 weeks
The change in WSRS of the test and control groups
The change in WSRS of the test and control groups from baseline at 2, 8, 16, 24 weeks as assessed by the Investigator
Time frame: baseline and 2, 8, 16, 24 weeks
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