Results From Phase 4 Clinical Studies of Restylane Refyne and Restylane Defyne Released

Phase 4 Clinical Study Results on Restylane Refyne and Defyne

Galderma has released the results from two Phase 4 clinical studies of Restylane Refyne and Restylane Defyne, the most recent U.S. additions to it Restylane family of soft tissue fillers. The Natural Expression study found that natural facial expression was maintained in 95% (60/63) of subjects (primary objective). The Dynamic Strain study found that 83% (25/30) of subjects had enhanced attractiveness, looked younger and maintained expression following injections of Restylane Refyne and Restylane Defyne. Outcomes of both studies were presented during the Aesthetic & Antiaging Medicine World Congress (AMWC) in April.

“Restylane Refyne and Restylane Defyne were designed to remain flexible and integrate with the tissue so they could be used in animated areas of the lower face, such as the nasolabial folds, and still allow for natural expression in motion,” said consulting investigator, Wolfgang Philipp-Dormston, MD. “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 of the Dynamic Strain study are impressive as they confirm published findings from previous clinical studies on dynamic strain. The new data offer clear and objective evidence that dermal fillers may help patients achieve a more youthful appearance when treating facial areas prone to volumetric effects of aging such as the nasolabial folds and marionette lines,” said consulting investigator, Ivona Percec, MD, PhD.