Phase IV study results for Restylane dermal fillers indicate benefits in facial expressions- Galderma

Galderma announced the results from two Phase IV clinical studies of its most recent additions to the Restylane family of products in the U.S., Restylane Refyne and Restylane Defyne. The Natural Expression study found that naturalness in facial expressions was at least maintained in 95% (60/63) of subjects (primary objective). Additionally, results from the Dynamic Strain study found that 83% (25/30) of subjects had enhanced attractiveness, looked younger and at least maintained naturalness, post Restylane Refyne and Restylane Defyne injections. Restylane Refyne and Restylane Defyne were recently approved by the FDA for the treatment of nasolabial folds (NLF) or "laugh lines," in patients over the age of 21. Restylane Refyne was approved for the treatment of moderate to severe facial wrinkles and folds, such as NLF, and Restylane Defyne for the treatment of moderate to severe, deep facial wrinkles and folds, such as NLF. The Natural Expression study was designed to measure the perception of facial expressions through a series of evaluation techniques to confirm that natural expression could be maintained as the face animates. Until now, proven results through a combination of these techniques and innovative methods for measurement have not been reported. Results from these studies will be presented during the Galderma Symposium at the 15th Aesthetic & Anti-aging Medicine Annual World Congress.