Boca Andreea, Fanian Ferial, Smit Riekie, Redaelli Alessio, Goorochurn Ranesha, Issa Hanane, Sukmanskaya Natalia, Philippon Valérie, Dell' Avanzato Roberto
Private Clinic, Cluj, Romania.
Scientific Department, FILLMED Laboratories, Paris, France.
J Cosmet Dermatol. 2024 Dec;23(12):3974-3985. doi: 10.1111/jocd.16547. Epub 2024 Oct 2.
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.
PATIENTS/METHODS: 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.
皮肤再生修复涉及多次皮内注射以改善皮肤质量，但由于皮肤厚度存在差异，精确的真皮层靶向注射具有挑战性。更细、疼痛感更低且皮肤反应更少的针头是有吸引力的选择。
本研究评估一种新型微针设备与皮肤再生修复中使用的传统针头相比的性能和安全性。
患者/方法：招募面部和颈部皮肤老化的受试者。评估安全性指标，包括即时和局部耐受性。性能指标测量皮肤光泽度、皱纹和光老化等级、水合作用、表皮下低回声带、真皮厚度和皮肤弹性。受试者和研究者均记录全球美学改善量表评分。
与传统针头相比，微针注射表现出更优的性能，这受到特定皮肤区域和厚度的影响。微针在第49天时，对于眶周区域和鼻唇沟的皮肤皱纹改善效果更佳，分别降低了14.5%（p = 0.01）和15%（p = 0.004），对于颈部皱纹降低了9.6%（p = 0.0008）。Nanosoft设备在第42天时对脸颊区域的皮肤水合作用改善更快（p = 0.04），在第75天时对颈部区域的皮肤水合作用改善更快（p = 0.01）；在第75天时对皮肤光泽度改善更快（p = 0.03），在第120天时对皮肤光泽度改善更快（p = 0.0098）。体外研究证实了微针在真皮层中产品放置的准确性。微针的不良事件更轻微，未发生严重不良事件。
两种针头均显著改善了皮肤质量，但微针增强了皮肤再生修复程序的效果，特别是在减少皮肤皱纹、提高弹性和整体皮肤水合作用方面。
