A 48-week, single-center, randomized, patient \& evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
65
Test device
Comparator Device
Wrinkle Severity Rating Scale (WSRS)
Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
Time frame: 24 weeks
Wrinkle Severity Rating Scale (WSRS)
Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
Time frame: 8 weeks, 16 weeks, 36 weeks, 48 weeks
Global Aesthetic Improvement Scale (GAIS)
Measure improvement status of wrinkle from score of -1 (worse) to 3 (very much improved)
Time frame: 8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks
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