Actively Recruiting
Study to Assess Safety and Effectiveness of DMFI150 Device for Treating Moderate to Severe Nasolabial Folds in Adults
Led by Samyang Biopharmaceuticals Corporation · Updated on 2026-03-05
30
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of DMFI150, a device designed to treat nasolabial folds, which are wrinkles around the nose and mouth. This prospective clinical investigation involves 30 adult participants and aims to assess how well the device reduces wrinkle severity using validated aesthetic scales, while monitoring overall safety during the study. Participants will receive a single injection of the investigational device DMFI150 targeting nasolabial folds. The study includes no placebo or comparator groups and focuses on a one-time treatment administered during the trial period. Throughout the 12 months following treatment, participants will be assessed at multiple intervals to measure changes in wrinkle severity using the Wrinkle Severity Rating Scale WSRS and the Global Aesthetic Improvement Scale GAIS. Safety will be closely monitored by tracking any treatment-related adverse events, serious adverse events, and device deficiencies. This study provides detailed follow-up assessments from baseline through one year after treatment.
CONDITIONS
Brief Title
A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds
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