The interim 6-month results in the ongoing clinical trial of Emervel Classic Lidocaine for the treatment of moderate to severe nasolabial folds shows positive results, Galderma reports.
Emervel is being compared to Juvederm Ultra in the study. At week 24, results from the multi-center, evaluator-blind and randomized split-face comparative clinical study show that Emervel Classic Lidocaine was non-inferior to Juvederm Ultra in regard to efficacy. The pre-incorporated lidocaine in Emervel was absorbed rapidly at the time of injection, according to the results from Galderma, and pain relief continued throughout the 60 minutes of post-injection follow-up. The safety profile of both products was similar and the pain score profile of Emervel was favorable.
Galderma reports that an independent team was gathered to assess the 6-month results in order to maintain the integrity of the trial. The 6-month results are expected to be published with the final 12-month results in a medical journal and potentially presented at an appropriate conference.
"As a principal study investigator for the study I found this HA filler to be easy to inject and control and robust in its character to lift,” says Gary D. Monheit, MD, associate clinical professor at the University of Alabama at Birmingham. “Due to its unique character of excellent filling at multiple levels plus its soft and natural feel it will be a major contribution in our cosmetic toolbox for facial rejuvenation. The patients tolerated this procedure well due to the lidocaine with little side effects and good results."
The Emervel line is a range of five hyaluronic acid dermal fillers, four of which contain lidocaine. The line is indicated for the treatment of facial lines, lips, contouring and volume loss.
