Phase 4 Studies of Restylane® Refyne and Restylane® Defyne Show Lasting Natural Benefit

Thursday, April 06, 2017 | Phase 3/4 Trials , Fillers & Injectables , Galderma


Two Phase 4 clinical studies of Restylane® Refyne and Restylane® Defyne show that the natural-looking results last.

Specifically, the Natural Expression study found that naturalness in facial expressions was at least maintained in 95 percent (60/63) of subjects (primary objective). Additionally, results from the Dynamic Strain study found that 83 percent (25/30) of subjects had enhanced attractiveness, looked younger and at least maintained naturalness, post Restylane® Refyne and Restylane® Defyne injections.

The findings were presented during the Galderma Symposium at the 15th Aesthetic & Anti-aging Medicine Annual World Congress (AMWC) taking place from April 6-8 in Monaco. Restylane® Refyne and Restylane® Defyne were recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of nasolabial folds (NLF) or "laugh lines," in patients over the age of 21.

About the Natural Expression Study

Topline clinical data from the multi-center, non-comparative study evaluated the perception of the naturalness of facial expressions in motion following correction of wrinkles and folds, such as NLF, in the lower face following treatment (primary objective). Overall the study demonstrated that naturalness was at least maintained in 95 percent (60/63) of the treated subjects**, fulfilling the primary objective. The study also demonstrated that attractiveness was enhanced in 89 percent (56/63) of subjects, and 79 percent (50/63) of the subjects looked younger. By introducing facial contraction patterns, static and in movement, useful tools were presented to assess the impact of facial treatment of the lower face.

About the Dynamic Strain Study

Topline clinical data from the multi-center, non-comparative study evaluated the naturalness of facial expressions following correction of wrinkles and folds, such as NLF, in the lower face, as well as the dynamic strain in facial expressions using 3D stereophotogrammetry (Canfield Scientific, Inc) to objectively quantify surface soft-tissue strain associated with various facial expressions. Thirty (30) treated females (40-65 years old) showed a statistically significant reduction in mean peak dynamic strain in the facial regions, for various standardized expressions, one-month post-treatment, compared to baseline (p < 0.05).** Results found that 83 percent (25/30) of subjects had enhanced attractiveness, looked younger and maintained naturalness. These data demonstrated both subjectively and objectively that treatment with Restylane® Refyne and Restylane® Defyne provided a more attractive and youthful appearance, without compromising naturalness in facial animation of the lower face.

For these Phase 4 studies, initial treatment injection site responses (redness, swelling, bruising, lump/bump formation, pain/tenderness) were predominantly mild or moderate in intensity, temporary (typically with a duration of one to two weeks), and similar to the NASHA™ (Stabilized Non-Animal Hyaluronic Acid) Technology Restylane® products.

 

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