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比较两种用于丰唇的透明质酸凝胶安全性和效果的随机、评估者盲法研究。

Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement.

作者信息

Hilton Said, Sattler Gerhard, Berg Anna-Karin, Samuelson Ulf, Wong Cindy

机构信息

Medical Skin Center, Düsseldorf, Germany.

Rosenpark Research, Darmstadt, Germany.

出版信息

Dermatol Surg. 2018 Feb;44(2):261-269. doi: 10.1097/DSS.0000000000001282.

Abstract

BACKGROUND

Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect.

OBJECTIVE

To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement.

MATERIALS AND METHODS

Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product.

RESULTS

A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated.

CONCLUSION

Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

摘要

背景

透明质酸(HA)填充剂在凝胶特性和易用性方面可能存在差异,这种差异是否会影响安全性和效果持续时间备受关注。

目的

比较两种采用不同技术生产的HA填充剂用于丰唇的长期安全性和效果。

材料与方法

嘴唇极薄至中等厚度的受试者被随机分组,分别接受HA-RK(N = 31)或HA-JV(N = 29)治疗,使用最多3 mL产品,按照5分制将唇部丰满度提高≥1级。

结果

将唇部丰满度提高≥1级时,与HA-JV相比,HA-RK所需的体积更小(平均:1.54 mL对1.94 mL,p <.001)。尽管体积较小,但两组唇部丰满度和整体美学改善程度相当持久。6个月时,HA-RK组与HA-JV组分别有60.0%和57.7%的受试者唇部丰满度得到改善。12个月时,盲法评估显示美学改善的比例分别为71.4%和76.0%,感觉更有吸引力的比例分别为—— 85.7%和86.2%。两种产品耐受性均良好。

结论

两种产品均能持久改善唇部丰满度和美观外观。与HA-JV相比,HA-RK达到最佳治疗效果所需的量显著更少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/519b/5821480/7216b99db100/ds-44-261-g002.jpg

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