Evaluation of the Performance and Safety of a New Micro-Needle Technology in Comparison With the Classic Needle on...

Skin biorevitalization involves multiple intradermal injections to enhance skin quality, but precise dermal targeting can be challenging due to variations in skin thickness smaller, less painful needles with fewer skin reactions are attractive options.

This study evaluates a new Micro-Needle device's performance and safety in comparison with the classic needle used in skin biorevitalization.

Subjects with facial and neck skin aging were enrolled. Safety outcomes, including immediate and local tolerability, were assessed. Performance outcomes measured skin radiance, wrinkles and photoaging grade, hydration, subepidermal low echogenic band, dermis thickness, and skin elasticity. Both subjects and investigators recorded Global Aesthetic Improvement Scale scores.

Micro-Needle injections demonstrated superior performance compared to the classic needle, influenced by the specific skin zones and thickness. Micro-Needle was superior for skin wrinkles at D49 for periorbital zone and nasolabial folds by -14.5% (p = 0.01) and -15% (p = 0.004), respectively, and for neck by 9.6% (p = 0.0008). The Nanosoft device showed a faster improvement for skin hydration at D42 for the cheek zone (p = 0.04) and at D75 for the neck area (p = 0.01); and for skin radiance at D75 (p = 0.03) and at D120 (p = 0.0098). Ex vivo studies confirmed the Micro-Needle's accuracy in product placement in the dermis. Adverse events were milder with Micro-Needle and no serious adverse events occurred.

Both needles significantly improved skin quality, but Micro-Needle enhanced the outcomes of skin biorevitalization procedures, particularly in terms of skin wrinkle reduction, elasticity, and overall skin hydration.