Study to Compare the Safety and Effectiveness of DMFI300 and Ellans-M Injections for Treating Nasolabial Folds in Adults

What this Trial Is About

Researchers are evaluating the performance and safety of DMFI300, a device designed to treat nasolabial folds and wrinkles. This prospective, randomized, controlled clinical trial includes 30 adult participants who will receive injections of both the investigational device DMFI300 and a comparator device, Ellans-M, using a split-face design. The study aims to assess wrinkle severity and overall safety over time. Participants will be treated with injections of DMFI300 on one side of the face and Ellans-M on the other side. The study is double-blinded and randomized to fairly compare the two devices. Treatments and evaluations will be conducted from baseline up to 12 months, with several follow-up visits to monitor changes in wrinkle severity and any adverse events. During the study, participants will undergo assessments using the Wrinkle Severity Rating Scale WSRS and the Global Aesthetic Improvement Scale GAIS at multiple time points up to one year. Researchers will also record participant satisfaction using a five-point scale and track any treatment-related adverse events. The main outcome is the change in wrinkle severity from baseline to 12 months, with safety and effectiveness monitored throughout the study period.

A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds