Safety and Efficacy of a New Hyaluronic Acid Filler for Lip Augmentation: A Prospective, Multicenter, Randomized, Controlled Study

Abstract Background Lip augmentation has become increasingly accepted and popular. However, there are still a few approved lip fillers that are versatile, biocompatible, suitable for lip enhancement, and backed by large-scale clinical trials. Objectives To assess the safety and effectiveness of Janlane LIPs (Shanghai Qisheng Biopharmaceutical Co., Ltd, Shanghai, China), a new hyaluronic acid filler for lip augmentation. Methods This prospective, multicenter, randomized, controlled study randomized subjects to the treatment group or the concurrent no-treatment control group that received delayed treatment. The level of Lip Fullness Grading Scale (LFS) was evaluated by the blinded evaluator, and the Global Aesthetic Improvement Scale (GAIS) was evaluated by the blinded evaluator and the subjects at pre-injection and after injection. Adverse reactions were recorded. Statistical analysis of subject satisfaction was performed. Results A total of 176 subjects were enrolled. The scores of LFS after injection were higher than those before injection; the degree of GAIS evaluated by the evaluator and subjects improved significantly. Local redness, swelling, etc. occurred after injection, most of which resolved within 1 week. The patient satisfaction was high and statistically significant. Conclusions Janlane LIPs showed long-term aesthetic improvement and safety for lip augmentation, high patient satisfaction, and are worthy of clinical promotion. Level of Evidence: 2 (Therapeutic)