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

Condition(s) studied

Investigational drug(s) / intervention(s)

PN30 (RDM16): PN30 is a viscoelastic, sterile gel, in a disposable prefilled syringe for intradermal infiltration.PN30 contains polynucleotides (3%). The polynucleotides contained in the device are substances of natural, fish-derived origin, highly purified.

Study summary

Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging. Injectable anti-aging products have been widely used for aesthetic improvement of the skin.

In recent years, new filler products made from High Purification Technology Polynucleotides (PN HPTTM) have been developed and are now being used in Europe. PN HPTTM has a consolidated utilization in the aesthetic field and recently, specific guidelines in their utilization have been implemented. Polynucleotides (PNs) are polymeric chains formed by purines, pyrimidines, deoxyribonucleotides, and deoxyribonucleosides that can be found in cells throughout the human body. PNs have viscoelastic properties and the capability to bind, reorganize and orientate a high concentration of water molecules, creating 3D gel that undergoes an enzymatic cleavage.

On this basis, polynucleotide-containing products act as short-time temporary fillers to produce a volumizing effect and exert a lubricant and moisturizing action, due to the high concentration of water molecules. Moreover, they maintain for a long time the moisturizing and viscoelastic effect.

A recent report which summarizes the findings and recommendations issued from the Italian Scientific Board of aesthetic physicians, supports the use of PN-HPT.

In this context, the Sponsor has developed PN30, a soft-tissue filler containing PN-HPT (at a concentration of 30 mg/ mL) as functional ingredients which help improve skin turgor and elasticity due to their moisturizing and viscoelastic properties.

PN30 is a new device with no history of marketing but based on a similar product CE marked developed and sold by the Manufacturer with less amount of PN (2%). Therefore, the aim of this pre-market, twostages, monocentric, interventional, single-arm, clinical investigation is to evaluate the safety and the performance of PN30 (RDM16) for the improvement of skin hydration. The clinical investigation is planned as an adaptative two-stages study.

The planned procedures will be the same for both stages. The primary objective/endpoint of STAGE I will be to evaluate the safety, while the primary objective/endpoint of STAGE II will be to evaluate the performance of the device.

Eligibility

Primary outcome measure(s)

• Stage I - Skin examination (through evaluation of possible cutaneous reactions) — From enrollment to the end of study at 12 weeks ± 7 days after last treatment
• Stage I - Device deficiencies monitoring — At baseline (first injection) and 5 weeks ± 7 days from baseline (second and last injection)
  A device deficiency (DD) is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. This definition includes device deficiencies related to the investigational medical device. The rate of DD will be assessed and counted by the investigator at baseline (Visit 0), at Visit 1 and at Visit 2.
• Stage I - Adverse events, serious adverse events and concomitant medications monitoring. — From enrollment to the end of study at 12 weeks ± 7 days after last treatment
  Adverse events, serious adverse events and concomitant medications will be monitored during the entire study duration. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken.
• Stage II - Aesthetic evaluation of the skin through the change in Global Aesthetic Improvement Scale (GAIS) completed per each area treated by the Investigator — 10 weeks from the last treatment
  To evaluate the performance of PN30 for the aesthetic improvement of the skin after 10 weeks from the last treatment, the change in Global Aesthetic Improvement Scale (GAIS, rated on a 5-point scale (1= very much/extremely improved; 2= much improved; 3= improved; 4= no change; 5= worse)) from V2 to baseline (pre-treatment) will be assessed. The GAIS will be completed per each area treated by the Investigator. The pre-treatment GAIS score (at baseline/V0) will be "4" for each area treated for all subjects enrolled.

Trial sites (1)

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