Di Rosa Luigi, De Pasquale Antonino, Baldassano Sara, Marguglio Noemi, Drid Patrik, Proia Patrizia, Vasto Sonya
Department of Biological, Chemical and Pharmaceutical Sciences and Technologies (STEBICEF), University of Palermo, 90100 Palermo, Italy.
Independent Researcher, 95100 Catania, Sicily, Italy.
Biomedicines. 2024 Apr 20;12(4):916. doi: 10.3390/biomedicines12040916.
This study explores the efficacy of a novel polycomponent formulation (KARISMA Rh Collagen FACE, Taumedika Srl, Rome, Italy), containing 200 mg/mL of non-crosslinked high-molecular-weight hyaluronic acid (HMW-HA), 200 μg/mL of a human recombinant polypeptide of collagen-1 alpha chain, and 40 mg/mL of carboxymethyl cellulose (CMC) as a regenerative medicine for skin regeneration and rejuvenation. This formulation combines non-crosslinked high-molecular-weight hyaluronic acid, human recombinant polypeptide of collagen-1 alpha chain, and carboxymethyl cellulose to stimulate collagen type I production and enhance skin hydration. This study involved 100 subjects with varying skin conditions, divided into three groups based on skin aging, smoking history, and facial scarring, to evaluate the product's effectiveness in skin regeneration and aesthetic improvement. The methodology included two injections of Karisma (2 mL for each injection) one month apart, with evaluations conducted using FACE-Q questionnaires, the SGAIS Questionnaire, and Antera 3D skin scanner measurements at baseline, 30 days, and 60 days post-treatment. The results demonstrated a significant reduction in skin roughness and an improvement in skin quality across all the groups, with no correlation between the outcomes and the patient's age. The subjective assessments also indicated high satisfaction with the treatment's aesthetic results. The analyzed data allow us to conclude that the single-stranded collagen with hyaluronic acid and carboxymethyl-cellulose formulation is able to stimulate the skin's regenerative response, yielding significant results both in vitro and, through our study, also in vivo. This new polycomponent formulation effectively stimulates skin regeneration, improving skin quality and texture, with significant aesthetic benefits perceived by patients, and a low incidence of adverse events, marking a promising advancement in regenerative medicine.
本研究探讨了一种新型多组分制剂(KARISMA Rh Collagen FACE,Taumedika Srl,罗马,意大利)的疗效,该制剂含有200 mg/mL的非交联高分子量透明质酸(HMW-HA)、200 μg/mL的胶原蛋白-1α链人重组多肽以及40 mg/mL的羧甲基纤维素(CMC),作为用于皮肤再生和年轻化的再生医学产品。该制剂将非交联高分子量透明质酸、胶原蛋白-1α链人重组多肽和羧甲基纤维素结合起来,以刺激I型胶原蛋白的产生并增强皮肤水合作用。本研究纳入了100名皮肤状况各异的受试者,根据皮肤老化、吸烟史和面部瘢痕情况分为三组,以评估该产品在皮肤再生和美学改善方面的有效性。方法包括每隔一个月注射两次Karisma(每次注射2 mL),在基线、治疗后30天和60天使用FACE-Q问卷、SGAIS问卷以及Antera 3D皮肤扫描仪测量进行评估。结果表明,所有组的皮肤粗糙度均显著降低,皮肤质量得到改善,且结果与患者年龄无关。主观评估也表明对治疗的美学效果高度满意。分析的数据使我们得出结论,含透明质酸和羧甲基纤维素的单链胶原蛋白制剂能够刺激皮肤的再生反应,在体外以及通过我们的研究在体内均产生显著效果。这种新的多组分制剂有效地刺激了皮肤再生,改善了皮肤质量和质地,患者明显感受到了美学益处,且不良事件发生率较低,标志着再生医学领域有前景的进展。