PDF(Pubmed)
Abstract：
A new injectable solution containing low-molecular-weight hyaluronic acid (HA) and a specific amino acid mixture was formulated with proper aesthetic performance for the main signs of facial skin photoaging. The present study aimed to investigate its new application for rejuvenating and augmenting labia majora using clinical and biometric assessments. Three sessions of intradermal injections were performed using 3 ml of test extracellular matrix (ECM) for 10 eligible post-menopause female subjects (age 53.6 ± 7.93 years). The effectiveness of the intervention was assessed by an independent physician using before-and-after pictures based on the physician\'s global assessment score. Objective biophysical skin assessments, including skin hydration, skin erythema, and melanin index, as well as elasticity parameters including firmness (R0), gross elasticity (R2), and net elasticity (R5), were also performed before the first injection and then on the 2nd and 12th weeks after the last session. Patients\' satisfaction and all reported or observed adverse events were documented. At week 12, all the subjects reported an aesthetic improvement of 25% or more in rejuvenation and sagging of the labia major area. A statistically significant improvement was also detected in R0 and R5 at week 12 (p-values 0.005 and 0.022, respectively). Patient satisfaction surveys revealed a median score of 8 at both follow-up visits. The results showed a new indication of the tested HA ECM for providing a beneficial, durable, rejuvenating effect on the labia majora with a good safety profile.
摘要：
配制了一种含有低分子量透明质酸（HA）和特定氨基酸混合物的新型可注射溶液，具有适当的美学性能，可用于面部皮肤光老化的主要症状。本研究旨在研究其使用临床和生物特征评估来恢复和扩大大阴唇的新应用。使用3ml测试细胞外基质（ECM）对10名合格的绝经后女性受试者（年龄53.6±7.93岁）进行了3次皮内注射。干预的有效性由独立医师根据医师的总体评估评分使用前后图片进行评估。客观的生物物理皮肤评估，包括皮肤水合作用,皮肤红斑,和黑色素指数,以及包括硬度(R0)在内的弹性参数，总弹性(R2)，和净弹性(R5)，也在第一次注射之前进行，然后在最后一次注射后的第2周和第12周进行。记录患者满意度和所有报告或观察到的不良事件。在第12周，所有受试者报告了阴唇主要区域的恢复和下垂的美学改善25％或更多。在第12周时在R0和R5中也检测到统计学上显著的改善(p值分别为0.005和0.022)。患者满意度调查显示，两次随访中的中位数均为8分。结果表明，所测试的HAECM提供了有益的新指示，耐用,对大阴唇的恢复效果具有良好的安全性。
