This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Plastic Surgery InstituteNo
No. 33 Badachu Road, Shijingshan District, Beijing Municipality, China
Effectiveness of study treatment in correction of nasolabial folds up to 12 months after a single treatment:
* Investigator evaluated wrinkle severity using wrinkle severity rating scale (WSRS) * Improvement in subject and investigator rated global aesthetic improvement (GAIS) compared to baseline. * Subject satisfaction
Time frame: up to 12 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety of study treatment after single and repeat treatment of nasolabial folds will be assessed by: * Local tolerability (reported by subjects in a 14-day diary) * Adverse Events
Time frame: Up to 12 months
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