A multi-center study of Restylane for treatment of nasolabial folds in China

• Published in: Chinese medical journal Vol. 123; no. 2; pp. 173 - 177
• Main Author: YAN Xiao-qing CHEN Li-yang HUANG Lv-ping YOU Lei MA Yong-guang LU Chang-sheng LI Wei XU Jun
• Format: Journal Article
• Language: English
• Published: Department of Plastic Surgery, Clinical Division of Surgery, Chinese People's Liberation Army General Hospital, Beijing 100853, China%Department of Plastic Surgery, Peking University Third Hospital, Beijing 100038, China%Department of Facial Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Science, Beijing 100144, China%Department of Plastic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China%Division of Biometrics, Clinical Pharmacology Center, Fu Wai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China 20.01.2010
• Subjects: 中国; 主观评估; 多中心; 安全问题; 欧洲国家; 治疗效果; 透明质酸; 鼻; multicenter studies; rhytidoplasty; dermal filler; hyaluronic acid
• ISSN: 0366-6999
• DOI: 10.3760/cma.j.issn.0366-6999.2010.02.009

Background Restylane, a hyaluronic acid gel, has been widely used as a dermal filler in USA and European countries. This study was designed to study the safety and efficacy of Restylane as a non-permanent dermal filler for facial augmentation therapy in China for the correction of nasolabial folds during a follow-up period of 6 months. Methods The study consisted of a screening visit, a baseline visit during which injection with Restylane was given, and follow-up visits after four weeks, three months and six months. The efficacy was subjectively assessed by comparing the treatment results between pre-treatment and post-treatment. Adverse events were analyzed by severity and duration. Results At six months post-baseline, the subjects and the investigators＇ independent assessment score of Wrinkle Severity Rating Scale was decreased. Global Aesthetic Improvement Scale was considered to have improved by over 90% in some cases. Adverse events related to product and injection was reported in 21.5% of the injections. A vast majority of the post-treatment reactions were mild. Conclusions The efficacy of Restylane for nasolabial fold in a Chinese population was excellent. Restylane was well tolerated and no systemic reactions or other safety concerns were raised.