Clinical efficacy and safety of hyaluronic acid dermal filler in treating nasolabial folds in Chinese population
10.3760/cma.j.issn.1009-4598.2019.09.015
- VernacularTitle: 透明质酸皮肤填充剂在中国人群中矫正鼻唇沟皱褶的有效性和安全性评价
- Author:
Xiaonan YANG
1
;
Zuoliang QI
1
;
Jiaming SUN
2
;
Xiongzheng MU
3
;
Meng XIONG
4
;
Shuzhong GUO
5
;
Jiguang MA
6
;
Guangyu CHEN
7
;
Keming WANG
6
Author Information
1. The 16th Department of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100144, China
2. Department of Plastic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
3. Department of Plastic Surgery, Huashan Hospital, Fudan University, Shanghai 200040, China
4. Department of Plastic and Reconstructive Surgery, Zhongda Hospital, Southeast University, Nanjing 210009, China
5. Department of Plastic and Reconstructive Surgery, Xijing Hospital, Air Force Medical University, Xi′an 710032, China
6. The 17th Department of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100144, China
7. Cosmetic Injection Center of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100144, China
- Publication Type:Journal Article
- Keywords:
Hyaluronic acid;
Injection;
Nasolabial fold;
Evaluation
- From:
Chinese Journal of Plastic Surgery
2019;35(9):922-927
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the clinical efficacy and safety profile of hyaluronic acid dermal filler(Restylane®) in treating nasolabial folds in Chinese population.
Methods:103 subjects in this study were recruited from five Chinese clinical trial centers between July 2014 and December 2015. Subjects were treated with hyaluronic acid dermal filler in correcting nasolabial folds and an optional re-treatment was performed after 12 months according to the subjects′wishes. The improved of nasolabial folds was evaluated by the change of severity (wrinkle severity rating scale, WSRS) and aesthetic improvement (global aesthetic improvement scale, GAIS). Satisfaction of subjects on treatment was evaluated using subject satisfaction questionnaires (SSQ). Safety indicators such as pain, skin and soft tissue presentation at the injection site were continuously evaluated throughout the whole treatment process.
Results:Significant improvement in scores of WSRS and GAIS of all subjects was observed after treatment. Nine months after treatment, the scores of WSRS in 80 subjects (77.7%) and GAIS in 96 subjects (93.2%) were still improved. The 68 subjects (95.8%) received re-treatment after 12 months gained further improvement in nasolabial folds. Most adverse events were mild or moderate (transient/reversible local manifestations) and all resolved before study end, no severe adverse event related to products observed.
Conclusions:Hyaluronic acid dermal filler is effective and safe in treatment of nasolabial folds in Chinese population and the effect can last up to 12 months.