A multi-center study of Restylane for treatment of nasolabial folds in China
10.3760/cma.j.issn.0366-6999.2010.02.009
- Author:
Xiao-Qing YAN
1
;
Li-Yang CHEN
;
Lü-Ping HUANG
;
Lei YOU
;
Yong-Guang MA
;
Chang-Sheng L(U)
;
Wei LI
;
Jun XU
Author Information
1. Department of Plastic Surgery, Clinical Division of Surgery, Chinese People's Liberation Army General Hospital, Beijing 100853, China
- Keywords:
hyaluronic acid;
rhytidoplasty;
multicenter studies;
dermal filler
- From:
Chinese Medical Journal
2010;123(2):173-177
- CountryChina
- Language:Chinese
-
Abstract:
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.