Comparing Safety and Effectiveness of NOA VOLUME and JUVDERM VOLUMA XC Injections for Improving Mid-Face Volume in Adults

What this Trial Is About

Researchers are investigating the safety and effectiveness of NOA VOLUME, a crosslinked Hyaluronic Acid injectable gel with lidocaine, designed to improve mid-face volume in adults. This study compares NOA VOLUME with another injectable gel, JUVDERM VOLUMA XC, in adults seeking mid-face volume enhancement. The trial enrolls around 231 participants and aims to address facial volume loss caused by aging factors like collagen and elastin reduction. Participants are randomly assigned to receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. They may receive optional touch-up treatments on Day 31 and Month 18. The study includes two cohorts, with treatments administered under a quadruple-masked design to maintain objectivity. The follow-up period extends up to 31 months to monitor long-term outcomes. Throughout the study, participants will be assessed on their mid-face volume improvement using investigator and participant evaluations, including the Mid-Face Volume Deficit Scale and Global Aesthetic Improvement Scale. Safety is monitored by recording adverse events over the entire follow-up period. Participants will have scheduled visits for injections and evaluations, with the primary effectiveness measured at Month 6 and safety tracked up to Month 31.

A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Improvement of Mid-Face Volume