Yazdanparast Taraneh, Samadi Aniseh, Hasanzadeh Hournaz, Nasrollahi Saman Ahmad, Firooz Alireza, Kashani Mansour Nassiri
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Air Pollution, Health and Occupational Diseases Research Unit, Tehran, Iran.
J Cutan Aesthet Surg. 2017 Apr-Jun;10(2):101-105. doi: 10.4103/JCAS.JCAS_115_16.
Lips have a significant role in face aesthetic perception, and lip augmentation is one of the most commonly requested aesthetic procedures. Non-permanent dermal fillers, such as hyaluronic acid (HA), are used for augmenting the lips. This article presents the results of Phase II, before - after designed study, assessing the safety and efficacy of a soft tissue HA filler, for upper lip augmentation.
Investigators treated 10 healthy adult women 28-45 years old, using a single injection of Hyamax Kiss soft tissue HA filler (a product from Hyamed Laboratories, Switzerland) for upper lip augmentation. The primary efficacy endpoint was an increase in lip fullness at least one grade on Medicis Lip Fullness Scale at 2, 12 and 24 weeks post-treatment. Furthermore, the effectiveness and durability of filler were assessed using a 5-point Investigator's Global Assessment (IGA). Adverse events and volunteers' satisfaction were reported using visual analog scale.
Response to treatment (as defined above) after 2, 12 and 24 weeks were observed in 80%, 70% and 80% of patients, respectively. No statistical difference was found in response to treatment rate between follow-up visits ( = 0.83). The mean value of IGA score in weeks 2, 12 and 24 were 3.4 ± 0.96, 3.3 ± 0.67 and 3.3 ± 0.67, respectively. The study subjects were almost all satisfied with their lip improvement. Reported adverse effects were temporary and mostly mild in severity.
Soft tissue HA filler tested in this study was well tolerated, efficient and durable when used for upper lip augmentation.
嘴唇在面部美学感知中起着重要作用，丰唇是最常见的美容手术之一。非永久性真皮填充剂，如透明质酸（HA），被用于丰唇。本文介绍了一项前后设计的II期研究结果，该研究评估了一种软组织HA填充剂用于上唇填充的安全性和有效性。
研究人员对10名年龄在28至45岁之间的健康成年女性进行治疗，单次注射Hyamax Kiss软组织HA填充剂（瑞士Hyamed实验室产品）用于上唇填充。主要疗效终点是治疗后2周、12周和24周时，根据美迪西唇丰满度量表，嘴唇丰满度至少提高一个等级。此外，使用5分制的研究者整体评估（IGA）来评估填充剂的有效性和持久性。使用视觉模拟量表报告不良事件和志愿者的满意度。
分别在2周、12周和24周观察到80%、70%和80%的患者对治疗有反应（如上所定义）。随访期间治疗反应率无统计学差异（ = 0.83）。第2周、12周和24周IGA评分的平均值分别为3.4±0.96、3.3±0.67和3.3±0.67。研究对象几乎都对嘴唇改善情况感到满意。报告的不良反应是暂时的，严重程度大多为轻度。
本研究中测试的软组织HA填充剂用于上唇填充时耐受性良好、有效且持久。
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