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一项关于睫毛多生长因子血清的开放标签、单中心安全性和有效性研究。

An Open-label, Single-center, Safety and Efficacy Study of Eyelash Polygrowth Factor Serum.

作者信息

Sachdev Mukta, Velugotla Keerthi, Revanker Sapna, Somasekhar Geetha

机构信息

All authors are with MS Clinical Research in Bangalore, India.

Drs. Sachdev and Velugotla are also with MS Skin Clinic in Bangalore, India.

出版信息

J Clin Aesthet Dermatol. 2020 Feb;13(2):61-66. Epub 2020 Feb 1.

Abstract

We sought to evaluate the efficacy of a polygrowth factor serum for increasing length, luster, thickness, and volume of eyelashes in a group of healthy Indian women. This was a 90-day, open-label, single-center safety and efficacy study. Thirty Indian female participants, aged 15 to 45 years old, were enrolled in the study; 29 of these subjects completed the study. There were four assessment visits: at baseline (Day 0) and on Days 30, 60, and 90. Subjects were instructed on the application of the test product uniformly to both eyes on the upper and lower eyelid margins. Subjects applied the product once nightly for 90 days. At each visit, subjects underwent ophthalmological and dermatological assessments and digital image photographs using Visia CR imaging system. Improvement in eyelash length, density/volume, luster, and curl were evaluated using imaging and software technologies. Improvement in test parameters was observed 30 days after initiation of product usage. Among the 29 subjects who completed the study, improvements in length (10.52%), volume (9.3%), luster (11.43%), thickness (35%), and curl (50.83%), compared to baseline, were recorded. The study demonstrated efficacy in improving eyelash length, luster, thickness, and curl. The results were observed as early as 30 days of product usage and persisted until the last visit following 90 days of product usage. There were no adverse events associated with the product. We concluded that the polygrowth factor serum was well tolerated and effectively improved eye lash length, luster, thickness, and volume in our patient sample. Additional randomized, controlled studies with larger samples are needed to confirm our findings.

摘要

我们试图评估一种多生长因子血清对一组健康印度女性睫毛长度、光泽、厚度和体积增加的疗效。这是一项为期90天的开放标签、单中心安全性和疗效研究。30名年龄在15至45岁之间的印度女性参与者被纳入研究;其中29名受试者完成了研究。共有四次评估访视:基线期(第0天)以及第30、60和90天。指导受试者将测试产品均匀地涂抹于双眼的上下眼睑边缘。受试者每晚使用一次该产品,持续90天。每次访视时,受试者接受眼科和皮肤科评估,并使用Visia CR成像系统拍摄数码图像照片。使用成像和软件技术评估睫毛长度、密度/体积、光泽和卷曲度的改善情况。在开始使用产品30天后观察到测试参数有所改善。在完成研究的29名受试者中,与基线相比,睫毛长度(10.52%)、体积(9.3%)、光泽(11.43%)、厚度(35%)和卷曲度(50.83%)均有改善。该研究证明了在改善睫毛长度、光泽、厚度和卷曲度方面的疗效。早在使用产品30天时就观察到了结果,并且在产品使用90天后的最后一次访视时仍持续存在。未发现与该产品相关的不良事件。我们得出结论,在我们的患者样本中,多生长因子血清耐受性良好,有效地改善了睫毛的长度、光泽、厚度和体积。需要进行更多更大样本的随机对照研究来证实我们的发现。

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