Safety and Effectiveness of a Novel Hyaluronic Acid Gel for Lip Augmentation

Abstract

Objective: To compare the safety and efficacy of a novel hyaluronic acid injectable gel with 0.3% lidocaine (test device) with that of a commercially available injectable hyaluronic acid gel with 0.3% lidocaine (comparator) for lip augmentation. Methods: Eligible patients (n = 158) with an overall score of very thin (n = 0) or thin (n = 1) on a 5-point Lip Fullness Grading Scale (LFGS) participated in the double-blind, randomized, multicenter study. Efficacy was assessed periodically over 6 months on a per protocol (PP) population (definitive) and a modified intent-to-treat (mITT) population (supportive). Results: In the PP population, the mean change from baseline (day 56) in LFGS score was 1.52 for the test device and 1.53 for the comparator. This 56-day change was the primary efficacy endpoint. The 95% confidence interval (CI) limits for the mean difference in scores (test device minus comparator) were -0.33 and 0.31. In the mITT population, the corresponding 95% CI limits were -0.26 and 0.31. In both populations, the lower limits, -0.33 and -0.26, were higher than the prespecified -0.50, indicating that the test device was non-inferior to comparator. The adverse event profile was similar between the treatment groups. Ninety-three percent of patients treated with test device considered themselves improved, much improved, or very much improved at day 168 compared to 82% of those treated with comparator. The corresponding investigator improvement ratings were 100% and 76%, respectively Conclusion: For lip augmentation, the efficacy and safeety of the test d evice is non-inferior to comparator.