This is a multicenter, prospective, randomized, no-treatment controlled post-market clinical follow-up of a class III medical device. This study is designed to evaluate the safety and effectiveness of STYLAGE® XXL in the restorationor creation of volume in the mid-face.~The objective of this study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.~Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system.~Effectiveness of STYLAGE® XXL will be demonstrated if the mean volumetric change at 24 weeks after baseline from pre-treatment in the treatment group is statistically superior to the mean change in the delayed treatment (control) group.~In total, approximately 90 subjects will be enrolled across three study centers in Switzerland, Austria, and France.~Subjects will be randomized to the treatment group or delayed treatment (control) group at a 5:1 ratio (i.e., there will be 5 more subjects treated with STYLAGE® XXL at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with STYLAGE® XXL at 24 weeks after baseline).~The total duration of subject participation ranges from 18-19 months (treatment group) to 24-25 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30-31 months.
The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.