Efficacy and Safety of Rejuviel V in the Correction of Midface Volume Deficit
brief summary
The purpose is to evaluate the efficacy and confirm the safety of Rejeunesse Contour® with Lidocaine compared to Juvederm® Voluma® with Lidocaine for the temporary improvement of mid-face volume (including the cheekbone area, the anterior-medial cheek, and the area below the cheekbone). The investigational medical device will be administered a total of once during the entire clinical trial period (or up to twice if additional treatment is required). After the administration, photographs of the application site and evaluations using the Mid-Face Volume Deficit Scale (MFVDS) will be conducted at 4 weeks, 12 weeks, 24 weeks, and 48 weeks. Satisfaction with mid-face volume improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS). Additionally, changes in concomitant medications/treatments and adverse events will be reviewed in comparison to the previous visit.
official title
A Multicenter, Randomized, Subject & Evaluator-blinded, Matched Pairs, Non-inferiority, Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With Rejuviel V® With Lidocaine as Compared to JUVEDERM® VOLUMA® With Lidocaine for Temporary Restoration of Mid-face Volume