Evaluation of MD60002 Device for Facial Skin Aging

Brief Summary

This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic use in the treatment of skin imperfections and wrinkles caused by physiological facial aging. A total of 43 adult subjects presenting with facial wrinkles (Lemperle Wrinkle Severity Scale score ≥ 1) will be enrolled. Participants will receive intradermal injections of MD60002 according to a standardized protocol. The primary endpoint is the evaluation of aesthetic improvement measured by the change in the Lemperle Wrinkle Severity Scale (LWSS) score from baseline to the 30-day follow-up visit. Secondary endpoints include patient-reported subjective satisfaction evaluated via the Global Aesthetic Improvement Scale (GAIS), alongside comprehensive safety, tolerability, and device deficiency monitoring in accordance with ISO 14155 guidelines.