Chandrashekar B S, Sarangi Kalpana, Mastim Mushtaque A, Bhatia Ashima, Shah Manishkumar, Sharma Vijay, Gupta Mugdha, Gutte Ranjeet, Sharma Anuka, Sakhalkar Ulka
Dermatology, Cutis Academy of cutaneous sciences, Bengaluru, IND.
Dermatology, DKS Clinique, Mumbai, IND.
Cureus. 2022 May 21;14(5):e25190. doi: 10.7759/cureus.25190. eCollection 2022 May.
Background Growth factors from platelets have been emerging as a revolutionary treatment with the ability to induce cell growth in the skin, which results in retarding and reversing the aging process. Platelet-rich plasma (PRP) allows for greater release of growth factors and biologically active proteins, which in turn activates the cascade of stimulation of neoangiogenesis and collagen production. PRP is used in anti-aging and facial skin rejuvenation in the form of dermal injections and topical application during micro-needling. This study was conducted to assess the safety and efficacy of a topically applied face serum, MYOWNN™ (Wockhardt Ltd., Mumbai, India). MYOWNN™ is an autologous growth factor concentrate that has been made into a topical face serum. Methods Male and female subjects in the age group between 30 and 55 years (both inclusive) with Fitzpatrick skin type III-V who had not taken any oral or topical treatments for at least four weeks before and any platelet-rich plasma (PRP) based facial treatment (injections) at least six months before the study entry were included. MYOWNN™ serum was applied on the face once daily at night, approximately 30 minutes before sleeping preferably, for a total duration of five months. Six parameters, i.e. spots, pores, wrinkles, texture, moisture, and pigmentation, were evaluated at regular intervals with Visage-LS (dermaindia®, Tamil Nadu, India), a face analysis system that gives the live status of these six parameters and is an advanced live status skin detection equipment together with shooting, analyzing, and displaying functions, as well as the subjective analysis, was performed by subjects and physicians using different globally accepted scales like physician's global aesthetic improvement scale (PGAIS), subject's global aesthetic improvement scale (SGAIS), subject satisfaction score (SSS), and wrinkle severity rating scale (WSRS). For analysis, a mixed model for repeated measures was used. The model had change from baseline as the dependent variable visit as a factor and baseline assessment result as a covariate. All primary and secondary efficacy endpoints were analyzed using Modified Intent-to-Treat (mITT) populations. Results Improvement in an average of six anti-aging parameters was observed as early as three months while statistically significant improvement was observed by the end of five months of application. A statistically significant improvement in wrinkles was observed by the end of three months of the application itself. There were no product-related adverse events reported. Conclusions Five months of application of MYOWNN™ serum showed a statistically significant improvement in an average of six parameters of anti-aging and face rejuvenation with a p-value of 0.0150 (<5% level of significance (i.e. 0.05) and was also well-tolerated.
血小板衍生的生长因子已成为一种革命性的治疗方法,能够诱导皮肤细胞生长,从而延缓和逆转衰老过程。富含血小板的血浆(PRP)能释放更多的生长因子和生物活性蛋白,进而激活新生血管形成和胶原蛋白生成的刺激级联反应。PRP以真皮注射和微针治疗时局部应用的形式用于抗衰老和面部皮肤年轻化。本研究旨在评估局部应用的面部精华液MYOWNN™(印度孟买沃克哈特有限公司)的安全性和有效性。MYOWNN™是一种自体生长因子浓缩物,已制成局部面部精华液。
纳入年龄在30至55岁(含)之间、Fitzpatrick皮肤类型为III - V型的男性和女性受试者,他们在研究开始前至少四周未接受任何口服或局部治疗,且在研究入组前至少六个月未接受任何基于富含血小板血浆(PRP)的面部治疗(注射)。MYOWNN™精华液每晚睡前约30分钟面部涂抹一次,共持续五个月。使用Visage - LS(印度泰米尔纳德邦的dermaindia®)定期评估六个参数,即斑点、毛孔、皱纹、质地、水分和色素沉着,该面部分析系统可给出这六个参数的实时状态,是一种先进的实时皮肤检测设备,具备拍摄、分析和显示功能,同时由受试者和医生使用不同的全球公认量表进行主观分析,如医生整体美学改善量表(PGAIS)、受试者整体美学改善量表(SGAIS)、受试者满意度评分(SSS)和皱纹严重程度评定量表(WSRS)。分析时,使用重复测量的混合模型。该模型以基线变化作为因变量,访视作为因素,基线评估结果作为协变量。所有主要和次要疗效终点均使用改良意向性分析(mITT)人群进行分析。
早在三个月时就观察到平均六个抗衰老参数有所改善,而在应用五个月结束时观察到具有统计学意义的改善。在应用三个月结束时,皱纹有统计学意义的改善。未报告与产品相关的不良事件。
应用MYOWNN™精华液五个月显示,平均六个抗衰老和面部年轻化参数有统计学意义的改善,p值为0.0150(<5%显著性水平(即0.05)),且耐受性良好。