Pan Yuyan, Luo Zucheng, Chen Shuwei, Lu Nanhang, Zhang Yong, Yang Yanwen, Chen Cheng, Liu Jiaqi, Zhang Rufan, Ge Yining, Qi Fazhi, Zhu Ming
Department of Plastic Surgery, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Shanghai, 200032, China.
Aesthetic Plast Surg. 2025 Mar;49(6):1661-1668. doi: 10.1007/s00266-024-04378-3. Epub 2024 Sep 27.
Soft tissue fillers are used to improve the appearance of nasolabial folds (NLFs). This study aimed to compare the efficacy and safety of a new calcium hydroxylapatite microsphere hydrogel filler (Aphranel) versus Restylane for correcting NLFs.
In this multicenter, randomized, double-blind, parallel-grouped, positive-controlled, non-inferiority trial, 210 subjects were randomized to bilateral NLF treatment with Aphranel and Restylane on either side of the NLF. NLF was assessed before and right after injection and at the first week, first month, third, sixth, and 12 months. The primary efficacy endpoint was the WSRS improvement rate for the NLF, defined as ≥ 1 point improvement at Week 24. The secondary efficacy endpoints include the WSRS score assessed by investigators and the independent review committee (IRC) and the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjects, investigators, and IRC over time. Randomization was performed using a computer-generated randomization list. To ensure the double-blind nature of the study, neither the physicians administering the injections nor the patients receiving them were aware of the specific product being used. All syringes were identical in appearance, with labels coded instead of indicating the product name. The preparation of the injection products was handled by nurses who were not involved in the treatment process, thereby maintaining the blinding of both the physicians and the patients to the treatment assignment.
A total of 188 subjects (168 women and 20 men) completed the 12-month follow-up. The investigator-evaluated improvement rates using WSRS at 24 weeks were 84.04% for Aphranel and 78.72% for Restylane. The IRC-evaluated improvement rates using WSRS at 24 weeks were 72.34% for Aphranel and 70.21% for Restylane. Aphranel was shown to be statistically non-inferior to Restylane (P>0.05). Both the investigator and IRC-assessed WSRS scores over time showed that the mean scores for Aphranel were non-inferior to the mean scores for Restylane (all P>0.05). There was no difference between the Aphranel and Restylane groups according to the subjects, investigators, and IRC-assessed GAIS score at any time point (all P>0.05). Both devices' most frequently reported adverse events were injection site swelling and procedural pain.
This study confirms that Aphranel is an effective and safe treatment for correcting NLFs in Chinese subjects.
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软组织填充剂用于改善鼻唇沟（NLF）外观。本研究旨在比较一种新型羟基磷灰石微球水凝胶填充剂（Aphranel）与瑞蓝（Restylane）矫正鼻唇沟的疗效和安全性。
在这项多中心、随机、双盲、平行分组、阳性对照、非劣效性试验中，210名受试者被随机分为双侧鼻唇沟治疗组，一侧使用Aphranel，另一侧使用瑞蓝。在注射前、注射后即刻以及第1周、第1个月、第3个月、第6个月和第12个月对鼻唇沟进行评估。主要疗效终点是鼻唇沟的皱纹严重程度评分系统（WSRS）改善率，定义为在第24周时改善≥1分。次要疗效终点包括研究者和独立审查委员会（IRC）评估的WSRS评分，以及受试者、研究者和IRC随时间评估的全球美学改善量表（GAIS）。使用计算机生成的随机列表进行随机分组。为确保研究的双盲性质，注射的医生和接受注射的患者均不知道所使用的具体产品。所有注射器外观相同，标签采用编码而非注明产品名称。注射产品的配制由未参与治疗过程的护士处理，从而使医生和患者对治疗分配保持盲态。
共有188名受试者（168名女性和20名男性）完成了12个月的随访。在第24周时，研究者使用WSRS评估的Aphranel改善率为84.04%，瑞蓝为78.72%。IRC使用WSRS在第24周评估的Aphranel改善率为72.34%，瑞蓝为70.21%。结果显示Aphranel在统计学上不劣于瑞蓝（P>0.05）。研究者和IRC随时间评估的WSRS评分均显示，Aphranel的平均评分不劣于瑞蓝（所有P>0.05）。在任何时间点，根据受试者、研究者和IRC评估的GAIS评分，Aphranel组和瑞蓝组之间均无差异（所有P>0.05）。两种产品最常报告的不良事件均为注射部位肿胀和操作疼痛。
本研究证实Aphranel是一种有效且安全的治疗方法，可用于矫正中国受试者的鼻唇沟。
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