Sparavigna Adele, Tenconi Beatrice, Giori Andrea Maria, Bellia Gilberto, La Penna Laura
DERMING S.r.l., Clinical Research and Bioengineering Institute, Milan, Italy,
Research and Development, IBSA Farmaceutici Italia, Lodi, Italy.
Clin Cosmet Investig Dermatol. 2019 Jan 17;12:81-90. doi: 10.2147/CCID.S191935. eCollection 2019.
Aim of the study was to determine both clinically and by noninvasive instrumental evaluations the efficacy, tolerability and the duration of the effects of a new hyaluronic acid (HA) gel in human volunteers with moderate aging/photoaging.
Eighteen volunteers (35-55 years) were enrolled in this single-center study. The subjects underwent five visits. The first visit was at baseline to determine the adherence to the inclusion criteria, followed by the first injection of the HA-based study product, and the second visit was at 48 hours after the injection. Two months later, a second injection was given (Visit 3) followed by a subsequent visit (Visit 4) after 48 hours. The last visit (Visit 5) was performed 5 months after the first injection. Clinical and instrumental evaluations as well as self-assessment by the subjects were recorded at each visit.
A significant improvement of wrinkles' grade around the eyes, vertical lip lines and wrinkles' severity of nasolabial folds was recorded after the first injection and the effect increased after the second injection. Aging/photoaging grade and surface microrelief improved 2 months after the first injection procedure. These clinical improvements were paralleled by amelioration of instrumental skin profilometry and optical colorimetry. The treatments were very well tolerated by the volunteers as determined by the self-grading score.
The results confirm the good esthetic performance and the duration of the effect of the HA-based study product (Viscoderm Hydrobooster) on dynamic facial wrinkles and/or static facial lines. These effects were particularly evident after the second injection and were accompanied by a good tolerability of the product.
本研究旨在通过临床及非侵入性仪器评估,确定一种新型透明质酸(HA)凝胶对中度衰老/光老化人类志愿者的疗效、耐受性及效果持续时间。
18名志愿者(35 - 55岁)参与了这项单中心研究。受试者共接受五次访视。第一次访视是在基线期,以确定是否符合纳入标准,随后注射基于HA的研究产品,第二次访视在注射后48小时进行。两个月后进行第二次注射(第三次访视),48小时后进行后续访视(第四次访视)。最后一次访视(第五次访视)在第一次注射后5个月进行。每次访视均记录临床及仪器评估结果以及受试者的自我评估。
首次注射后,眼周皱纹等级、垂直唇纹及鼻唇沟皱纹严重程度均有显著改善,第二次注射后效果增强。首次注射程序后2个月,衰老/光老化等级及皮肤表面微结构得到改善。这些临床改善伴随着仪器皮肤轮廓测量及光学比色法的改善。根据自我评分,志愿者对治疗的耐受性良好。
结果证实了基于HA的研究产品(Viscoderm Hydrobooster)对面部动态皱纹和/或静态面部皱纹具有良好的美学效果及效果持续时间。这些效果在第二次注射后尤为明显,且产品耐受性良好。