Study to Assess Safety and Effectiveness of PN30 Polynucleotide Filler for Skin Hydration Improvement in Adults

What this Trial Is About

Researchers are studying a new polynucleotide-based soft-tissue filler called PN30 RDM16 designed to improve skin hydration, elasticity, and turgor. This clinical investigation is a pre-market, two-stage, single-arm trial to evaluate both the safety and performance of PN30, a product developed using High Purification Technology Polynucleotides PN HPTTM. These polynucleotides are natural substances with moisturizing and viscoelastic properties, intended to act as temporary fillers that enhance skin appearance by increasing hydration and firmness. The study involves administering PN30 via intradermal injections in a single treatment arm. PN30 is provided as a sterile, viscoelastic gel in prefilled syringes, containing 3% polynucleotides derived from natural fish origin. The investigation is adaptive with two stages Stage I focuses on safety assessment through skin examination and monitoring of device-related events, while Stage II evaluates the products aesthetic performance using various skin assessment tools. Participants will undergo injections and attend scheduled visits over approximately 12 weeks, during which researchers will assess skin reactions, hydration, elasticity, turgor, and patient satisfaction. Tools used include the Global Aesthetic Improvement Scale GAIS, MoistureMeterEpiD, ElastiMeter, and pain rating scales. Safety monitoring will continue through adverse event tracking and device deficiency checks. Participants must follow study guidelines regarding cosmetic use and sun exposure throughout the trial.

Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration