摘要

Objectives: To compare the effectiveness and safety of Evolysse/Estyme Smooth and Form (Symatese, Chaponost, France) to Restylane-L® (Galderma, Lausanne, Switzerland) for the treatment of nasolabial folds (NLFs). They study was conducted at 6 centers in the United States. Introduction: Dermal fillers have become the cornerstones of non-surgical procedures to correct cutaneous alterations linked to aging, with hyaluronic acid (HA)-based preparations being the most frequently used for the correction of wrinkles and folds. Several features differentiate the various HA fillers, including type of crosslinking agent used, degree of crosslinking, and viscoelastic properties. Evolysse/Estyme Fillers are new HA dermal fillers based on an innovative cross-linking process. Materials / method: The study was a prospective, split-face, randomized, double blind trial. 140 subjects with moderate-to-severe s NLFs were randomized to Evolysee/Estyme Smooth or Evolysee/Estyme Form on one side of the face and Restylane-L on the other side as a control and followed up for 12 months. The primary endpoint was the change from baseline to 6 months using a validated NLF scale score, comparing the two investigational devices to the active control in a non-inferiority design. Secondary endpoints included change in the NLF scores at other time points and aesthetic improvement. Results: The difference between Evolysse/Estyme Form and Restylane-L when comparing the degree of change at 6 months was -0.3 (95% CI -0.500, -0.032), with the upper bound of the 95% confidence interval well below the non-inferiority margin of 0.5, thus the primary endpoint of non-inferiority was met. The results for Evolysse/Estyme Smooth were similar. At 6 months the difference between Evolysse/Estyme Smooth and Restylane – L was -0.2 (95% CI -0.416, -0.019). Given that the upper bound of the 95% confidence interval was well below the non-inferiority margin of 0.5, establishing non-inferiority. Conclusion: In this FDA pivotal trial comparing two new HA based fillers, Evolysse/Estyme Form and Smooth to the active control Restylane-L, the two investigational devices were found to meet the primary endpoint of non-inferiority.