Safety and Effectiveness of Hyaluronic Acid Fillers With Lidocaine for Full-Face Treatment in Asian Patients.

Background There is a need for further evaluation of hyaluronic acid fillers for aesthetic use in Asia, where treatment goals may differ from western countries. Objective To evaluate 24-month safety and effectiveness of two hyaluronic acid fillers with lidocaine when used for full-face aesthetic treatment in Asian patients. Methods This was a 24-month, evaluator-blinded, non-comparative, multi-center study. Female subjects were injected with 3-5 mL Restylaner Lidocaine and/or Restylane Lyft Lidocaine, manufactured using the NASHAt technology, in 2n4 pre-defined areas; upper cheeks, nasolabial folds, temples, nose, and chin. A second treatment was performed after 12 months. Assessments included aesthetic improvement, subject satisfaction, assessment scales for upper cheeks and nasolabial folds, and safety (adverse events and subject diaries). Results One hundred subjects were included; total mean volumes were 4.7 mL and 3.1 mL at first and second treatment, respectively. At least 82% of subjects were rated as aesthetically improved over 24 months by subjects themselves and by investigators. Most subjects (73-90%) were satisfied with the treatment throughout the study. Upper cheek improvement 12 months after treatment was significantly higher after second treatment (g69% of subjects) than after first treatment (g38%), Pl0.0001, Fisherrs exact test. A total of 29 treatment related adverse events were reported by 16% of subjects, all were mild (79%) or moderate (21%) in intensity. Most commonly reported were pain and bruising. Tenderness was the most common diary record in all treatment areas. Conclusion Full-face treatments with the study products resulted in long-term aesthetic improvement, perceived by both subjects and investigators. Subject satisfaction was high and maintained over 24 months with one re-treatment. Repeated treatment of several facial indications showed a satisfactory safety profile. J Drugs Dermatol. 2020;19(9):836-842. doi:10.36849/JDD.2020.5374.