Wang Xiaojun, Wu Yan, Li Bi, Mu Xiongzheng, Li Li
Peking Union Medical College Hospital, Beijing, China.
Peking University First Hospital, Beijing, China.
J Cosmet Dermatol. 2022 Dec;21(12):6710-6716. doi: 10.1111/jocd.15286. Epub 2022 Oct 25.
Soft-tissue augmentation of the midface is increasingly requested by patients, and hyaluronic acid (HA) fillers are frequently used in treatment.
To evaluate the efficacy and safety of treatment of midface volume/contour deficit with a firm HA filler including lidocaine (HA ).
PATIENTS/METHODS: This was a 12-month, randomized, evaluator-blinded, controlled study. Chinese adults with mild to substantial volume loss were randomly assigned in a 3:1 ratio to treatment or untreated control groups.
A total of 148 subjects were enrolled. The primary objective was met; results of the midface volume scale (MMVS) rated by a blinded evaluator were in favor of HA at Month 6 (p < 0.0001 vs. the untreated control group). Similar to the MMVS improvement, improved midface fullness and aesthetic appearance was observed based on the Global Aesthetic Improvement Scale (GAIS) up to 12 months by both treating investigators and subjects (at least 96% at Week 4 and 65% at Month 12). Subject satisfaction was high, and the majority of subjects considered the results to look natural (>97%). The study product was well tolerated.
Midfacial treatment using HA was effective, well tolerated, and led to high levels of satisfaction in a Chinese population for up to 12 months.
NCT03097783.
患者对面中部软组织填充的需求日益增加,透明质酸(HA)填充剂常用于治疗。
评估含利多卡因的质地较硬的HA填充剂(HA )治疗面中部容量/轮廓缺陷的疗效和安全性。
患者/方法:这是一项为期12个月的随机、评估者盲法、对照研究。将有轻度至重度容量缺失的中国成年人按3:1的比例随机分配至治疗组或未治疗的对照组。
共纳入148名受试者。达到了主要目标;盲法评估者评定的面中部容量量表(MMVS)结果在第6个月时支持HA治疗组(与未治疗的对照组相比,p < 0.0001)。与MMVS的改善情况相似,治疗研究者和受试者均观察到,基于全球美学改善量表(GAIS),直至12个月时面中部饱满度和美观度均有所改善(第4周时至少96%,第12个月时65%)。受试者满意度较高,大多数受试者认为效果自然(>97%)。研究产品耐受性良好。
在中国人群中,使用HA进行面中部治疗有效、耐受性良好,且在长达12个月的时间里能带来较高的满意度。
NCT03097783。