Galderma to Begin Two Phase III Restylane Trials

Galderma is set to initiate a pivotal Phase III trial on Restylane® Lyft for hand augmentation and another that will look to the safety of Restylane® Silk when administered via cannula for perioral rejuvenation.  

 Restylane® Lyft Hand Rejuvenation Study

The pivotal Phase III trial is a randomized, controlled, multi-center U.S. study designed to assess the safety, tolerability and efficacy of the use of Restylane® Lyft to treat loss of volume in the hands. This is the first study on the use of the hyaluronic acid filler in the hands, and recruitment is already underway. Currently Restylane® Lyft is FDA approved for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, and for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies in patients older than 21. If successful, this trial could lead to the third major indication for Restylane® Lyft.

Restylane® Silk Cannula Study

The pivotal Phase III trial is a multi-center U.S. study designed to assess the safety and tolerability of Restylane® Silk when delivered via microcannula for lip enhancement and the treatment of lines around the mouth. Recruitment is slated to begin by the end of Q1 2016.