Clinical efficacy and safety of hyaluronic acid dermal filler in treating nasolabial folds in Chinese population

Objective To investigate the clinical efficacy and safety profile of hyaluronic acid dermal filler(Restylane®) in treating nasolabial folds in Chinese population. Methods 103 subjects in this study were recruited from five Chinese clinical trial centers between July 2014 and December 2015. Subjects were treated with hyaluronic acid dermal filler in correcting nasolabial folds and an optional re-treatment was performed after 12 months according to the subjects′wishes. The improved of nasolabial folds was evaluated by the change of severity (wrinkle severity rating scale, WSRS) and aesthetic improvement (global aesthetic improvement scale, GAIS). Satisfaction of subjects on treatment was evaluated using subject satisfaction questionnaires (SSQ). Safety indicators such as pain, skin and soft tissue presentation at the injection site were continuously evaluated throughout the whole treatment process. Results Significant improvement in scores of WSRS and GAIS of all subjects was observed after treatment. Nine months after treatment, the scores of WSRS in 80 subjects (77.7%) and GAIS in 96 subjects (93.2%) were still improved. The 68 subjects (95.8%) received re-treatment after 12 months gained further improvement in nasolabial folds. Most adverse events were mild or moderate (transient/reversible local manifestations) and all resolved before study end, no severe adverse event related to products observed. Conclusions Hyaluronic acid dermal filler is effective and safe in treatment of nasolabial folds in Chinese population and the effect can last up to 12 months. Key words: Hyaluronic acid; Injection; Nasolabial fold; Evaluation