This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
90
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned.
Each subject will receive treatment on Day 1 with Restylane Vital in one hand and the experimental device in the opposite hand, as randomly assigned
Galderma Research Site 01
Shanghai, Shanghai Municipality, China
Galderma Research Site 02
Hangzhou, Zhejiang, China
Galderma Research Site 03
Hangzhou, Zhejiang, China
The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0).
The VAS is a subjective scale to measure pain intensity. Total range is 0-100, 0 represents no pain and 100 represents the worst pain you can imagine, meaning a lower value is considered a better outcome in terms of a less painful treatment. The subject shall be instructed to put a vertical mark, approximating the pain experienced after the procedure, on a 100 mm horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the subject's VAS mark shall be measured with a standard ruler. Each hand will be evaluated independently.
Time frame: End of Injection (T0)
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