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

Abstract

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 Restylane® Lidocaine and/or Restylane Lyft Lidocaine, manufactured using the NASHA™ technology, in 2-4 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 (≥69% of subjects) than after first treatment (≥38%), P<0.0001, Fisher's 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.