A prospective, multi-centre, follow-up clinical study evaluating the safety and effectiveness of a 24mg/ml sodium hyaluronate soft tissue filler.

IF 1.2 4区 医学 Q3 DERMATOLOGY
Journal of Cosmetic and Laser Therapy Pub Date : 2021-08-01 Epub Date: 2022-02-20 DOI:10.1080/14764172.2022.2033784
Muna Kebede, Ernst Magnus Noah, Michael Weidmann, Soo Whan Choi, Maja A Hofmann
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引用次数: 0

Abstract

Highly concentrated hyaluronic acid dermal fillers commonly contain 20 mg/ml sodium hyaluronate. The soft tissue filler SF 24 contains 24 mg/ml sodium hyaluronate. It is a viscoelastic gel, which is moderately cross-linked and specifically designed to correct moderate to deep wrinkles and folds of facial skin.To evaluate the long-term safety and effectiveness of the SF 24 for facial augmentation.The primary endpoints were effectiveness and safety, which were measured by investigators' assessment of wrinkle/ fold/ defect severity and reaction severity, respectively. The Global Esthetic Improvement Scale (GAIS) evaluated secondary endpoints, such as patient and physician satisfaction. Data collection occurred at treatment date (day 0) and at each visit set at an interval of 21 days, 121 days, 213 days, and 395 days. A total of 74 individuals (3 male and 71 female) received treatment with SF 24 across five sites. The baseline value (2. 70) of wrinkle and fold severity was reduced to 1.22 directly after treatment and remained improved even after 273 days at 1.59. The improvements compared to baseline were all significant (p < .001). The injection-related reactions were mainly short-term (1-7 days), mild to moderate in severity, and resolved without intervention. SF 24 is safe and effective for facial volume augmentation. It shows long-lasting (9 months) results in treated patients.

一项前瞻性、多中心、随访的临床研究,评估24mg/ml透明质酸钠软组织填充剂的安全性和有效性。
高浓度透明质酸真皮填充剂通常含有20毫克/毫升的透明质酸钠。软组织填充物SF 24含有24毫克/毫升的透明质酸钠。它是一种粘弹性凝胶,适度交联,专门用于纠正面部皮肤的中度至深度皱纹和褶皱。目的:评价SF - 24在面部隆胸中的长期安全性和有效性。主要终点是有效性和安全性,分别通过研究者对皱纹/褶皱/缺陷严重程度和反应严重程度的评估来衡量。全球审美改善量表(GAIS)评估次要终点,如患者和医生满意度。数据收集在治疗日期(第0天)和每次访问设定的间隔为21天、121天、213天和395天。共有74名个体(3名男性和71名女性)在5个地点接受了SF 24治疗。基线值(2。70)的皱纹和褶皱严重程度在治疗后直接降低到1.22,即使在273天后仍保持改善,为1.59。与基线相比,改善均显著(p
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来源期刊
CiteScore
2.50
自引率
0.00%
发文量
36
审稿时长
>12 weeks
期刊介绍: A unique journal that focuses on the application of cosmetic laser and light therapies on the skin. The Journal of Cosmetic & Laser Therapy provides a forum for stimulating and up-to-date studies demonstrating the wide range of therapeutic options for clinicians and surgeons involved in cosmetic and dermatological treatment. The journal is aimed at dermatologists, cosmetic surgeons, plastic and facial plastic surgeons, oculoplastic surgeons and all those interested in the rapidly expanding field of cosmetic and laser therapy. Features include: -Cosmetic surgery, including facial rejuvenation, hair removal and skin resurfacing -Use of lasers and other light sources for cosmetic and dermatological treatment -Applications of peeling agents, fillers, injectables, implants and other cosmetic modalities -Topical treatments -Practical tips and safety issues
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