Evaluation of MD60002 Device for Facial Skin Aging

This clinical investigation is structured as a prospective, single-center, non-controlled, single-arm study designed to evaluate the performance and safety of the investigational Class III medical device MD60002. MD60002 is a sterile, biodegradable, isotonic intradermal gel formulated with 3% highly purified polynucleotides of fish origin in a physiological buffer. The primary mechanism of action relies on the hydrophilic properties of polynucleotides, which complex with water molecules to provide a natural volumizing and hydrating effect within the dermo-epidermal tissue, thereby improving skin tone, elasticity, and reducing aesthetic skin defects caused by physiological aging (such as wrinkles).

A total of 43 subjects will be enrolled at a single clinical site (Casa di Cura Santa Maria La Bruna, Torre del Greco, Italy) under the supervision of the Principal Investigator, Prof. Giuseppe Ferraro. The study population comprises adult subjects presenting with facial skin defects and wrinkles characterized by a baseline Lemperle Wrinkle Severity Scale (LWSS) score of 1 or greater.

Study Procedures and Schedule:

• Screening and Baseline (Visita 1): Assessment of inclusion and exclusion criteria, medical history review, pregnancy testing for women of childbearing potential, verification of concomitant medications, clinical evaluation of facial aging, baseline clinical photography, and assignment of the baseline LWSS score.
• Treatment (Visita 2): Administration of intradermal injections of the MD60002 device (up to a maximum of 2 ml depending on the defect) into the targeted facial areas using sterile techniques and the provided 30G 1/2 needles.
• Intermediate Treatment Visit (Visita 3): Conducted at 21 days (±6 days) post-baseline, involving a treatment session and safety checks.
• End of Study / Follow-up Visit (Visita 4): Conducted at 30 days (±7 days) following the final treatment session. This visit includes clinical evaluation of performance via LWSS scoring, patient-reported subjective satisfaction assessment using the Global Aesthetic Improvement Scale (GAIS), clinical photography, and thorough monitoring for any adverse events (AEs), serious adverse events (SAEs), or device deficiencies.

Endpoints and Statistical Analysis:

• Primary Endpoint: Evaluation of aesthetic performance measured by the change in the LWSS score between baseline and the 30-day follow-up visit. The primary objective is considered achieved if the median of individual LWSS score changes is ≤ -1 point, evaluated using a two-tailed Wilcoxon signed-rank test at a significance level of alpha = 0.05.
• Secondary Endpoint: Evaluation of patient-reported subjective satisfaction using the 5-point GAIS questionnaire at the final follow-up visit. The secondary objective is met if at least 70% of subjects report a GAIS score of 3 or better ("improved", "much improved", or "very much improved/excellent result").
• Safety Endpoints: Assessment of local tolerability, frequency and severity of expected and unexpected adverse events (AEs, ADEs, SAEs, SADEs), and device deficiencies in strict accordance with ISO 14155 guidelines.