Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.
This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
A facial tissue fixation material made of polydioxanone (PDO).
A facial tissue fixation material made of polydioxanone (PDO).
Hugel Inc.
Seoul, South Korea
RECRUITINGImprovement rate (%) at 12 weeks after the procedure compared to baseline.
Improvement rate (%) at 12 weeks after the procedure compared to baseline by an independent evaluator.
Time frame: Baseline to week 12
WSRS evaluation by an independent evaluator
Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.
Time frame: Baseline to week 4, 8, 24
WSRS evaluation by tester
Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.
Time frame: Baseline to week 4, 8, 24
Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.
Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline by the subject
Time frame: Baseline to week 4, 8, 12, 24
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