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

The study compared a novel hyaluronic acid injectable gel with lidocaine (test device) to a commercially available counterpart (comparator) for lip augmentation in 158 patients. The primary efficacy endpoint was the mean change in Lip Fullness Grading Scale (LFGS) score at day 56, which was 1.52 for the test device and 1.53 for the comparator. The 95% confidence intervals for the mean difference in scores indicated non-inferiority of the test device to the comparator. Both the per protocol and modified intent-to-treat populations supported these findings. The adverse event profiles were similar between the two groups. At day 168, 93% of patients treated with the test device reported improvement compared to 82% with the comparator, with investigator ratings of 100% and 76%, respectively. The conclusion is that the test device is as effective and safe as the comparator for lip augmentation.