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基于透明质酸的中胚层疗法产品的临床和生物统计学疗效:一项随机对照研究。

Clinical and biometrological efficacy of a hyaluronic acid-based mesotherapy product: a randomised controlled study.

机构信息

Dermatologist, Bordeaux, France.

出版信息

Arch Dermatol Res. 2013 Oct;305(8):673-82. doi: 10.1007/s00403-013-1360-7. Epub 2013 May 29.

Abstract

Data demonstrating the efficacy of hyaluronic acid (HA)-based mesotherapy for skin rejuvenation are scarce. The aim of the study is to assess the efficacy of non-reticulated HA-based mesotherapy on skin elasticity and complexion radiance. 55 women with cutaneous ageing signs included in the Full Analysis Set (FAS) population blindly received intradermal micro-injections (50 × 0.02 mL) of non-cross-linked HA filler with mannitol (Glytone 1, HA concentration: 14 mg/g) in one cheek and saline physiological solution in the other according to hemifacial randomisation in 3 monthly sessions. Elasticity (E1 and E2 stiffness parameters) and dermis thickness were measured by cutometry and 20 MHz echography, before (D0) treatment and 1 (1M) and 3 months (3M) after the last injection. A trained panel blindly scored skin complexion radiance from standardised and calibrated photographs, using 100 mm analogue scales. In the FAS population, only HA filler significantly decreased E1 at 1M (-10.9 %, p = 0.026) and 3M (-10.5 %, p = 0.035) compared with D0; its effect versus the control tended to be more persistent, with a difference between treatments at 3M close to significance (p = 0.063). E2 also decreased at 1M (-8.2 %, p = 0.027 in the per protocol population, n = 53) and 3M after HA-treatment only. Dermis thickness significantly increased after HA-treatment at 1M (+3.4 %, p = 0.028) and 3M (+4 %, p = 0.008), and after control-treatment at 1M only (+2.5 %, p = 0.015). The HA filler significantly improved complexion radiance at 3M compared with the control (p = 0.012) and for 51 % of subjects, their skin status. Non-reticulated HA-based mesotherapy significantly and sustainably improves skin elasticity and complexion radiance.

摘要

关于透明质酸(HA)基中胚层疗法在皮肤年轻化中的功效的数据很少。本研究旨在评估非交联 HA 基中胚层疗法对皮肤弹性和肤色光泽度的疗效。55 名有皮肤老化迹象的女性纳入全分析集(FAS)人群,根据半面随机化接受真皮内微注射(50×0.02 mL)非交联 HA 填充剂与甘露醇(Glytone 1,HA 浓度:14mg/g),一侧脸颊注射,另一侧脸颊注射生理盐水生理溶液,共 3 次,每月 1 次。在治疗前(D0)和最后一次注射后 1 个月(1M)和 3 个月(3M),使用皮肤弹性计和 20MHz 超声仪分别测量弹性(E1 和 E2 硬度参数)和真皮厚度。经过标准化和校准的照片,由经过培训的小组对皮肤肤色光泽度进行盲法评分,使用 100mm 模拟量表。在 FAS 人群中,仅 HA 填充剂在 1M 时(-10.9%,p=0.026)和 3M 时(-10.5%,p=0.035)显著降低 E1,与 D0 相比;其与对照的效果似乎更持久,3M 时治疗之间的差异接近显著(p=0.063)。仅在 HA 治疗后,E2 在 1M 时(-8.2%,在符合方案人群中,n=53,p=0.027)和 3M 时也降低。真皮厚度在 HA 治疗后 1M 时(+3.4%,p=0.028)和 3M 时(+4%,p=0.008)显著增加,仅在对照治疗后 1M 时增加(+2.5%,p=0.015)。与对照相比,HA 填充剂在 3M 时显著改善肤色光泽度(p=0.012),51%的受试者皮肤状况也得到改善。非交联 HA 基中胚层疗法可显著且持续改善皮肤弹性和肤色光泽度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6bf/3778226/09017f9b72df/403_2013_1360_Fig1_HTML.jpg

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