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A Multicenter Study of the Efficacy and Safety of Restylane in the Treatment of Nasolabial Folds in China

Plastic & Reconstructive Surgery2009Vol. 124(5), pp. 256e–257e

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Xiaoqing Yan, Jun Xu, Lu Chang-Sheng, Yong-guang Ma, Wei Li

Abstract

Sir: From 2005 to 2006, a study was carried out to determine the efficacy and safety study of Restylane (Medicis Aesthetics, Inc., Scottsdale, Ariz.) on the nasolabial fold in a Chinese population. This was an open-label, multicenter study. Subjects seeking augmentation therapy for nasolabial fold correction were recruited. Intradermal injection with Restylane was made at baseline, and a possible touch-up injection could be given 4 weeks later. The study consisted of a screening visit; a baseline visit; and follow-up visits after 4 weeks, 3 months, and 6 months. Efficacy was assessed subjectively by comparing the treatment results between before treatment and after treatment both by the investigator's evaluation and the subject's self-evaluation with the use of the Wrinkle Severity Rating Scale1 and the Global Aesthetic Improvement Scale. Safety was assessed by evaluation of adverse events following injection and the severity of the reported adverse events. Eighty-six subjects were recruited and treated and 75 subjects completed the 6-month follow-up period. All subjects were injected in both nasolabial folds and 14 subjects received a touch-up treatment in one or both nasolabial folds. After treatment, most subjects' nasolabial folds had improved bilaterally with one or two scores on the Wrinkle Severity Rating Scale. The efficacy analysis showed a very good treatment effect up to 6 months using the Wrinkle Severity Rating Scale. The percentage of responders was above 80 to 85 percent for both nasolabial folds, which is higher than in previous well-controlled randomized clinical studies in Europe and North America.2–4 As for assessments with the Global Aesthetic Improvement Scale, a large proportion of the subjects responded to treatment; 73 percent and 56 percent of subjects were responders at 6 months, according to investigators' and subjects' assessments, respectively. Posttreatment reactions of Restylane are anticipated after intradermal injection. The adverse events included 31 events related to the injection procedure (15.9 percent of the injections) and 11 events related to the study product (5.6 percent of the injections). By comparison with data from previous clinical studies with Restylane, it can be concluded that the frequency of these reactions in this Chinese study was similar to that in the published literature.2–4 A clear majority of the posttreatment reactions were mild and resolved spontaneously. Thus, it was concluded that the efficacy of Restylane for facial tissue augmentation in the Chinese population was excellent, with a high proportion of the subjects responding to treatment using two different scales for evaluation. Response was well sustained, with a significant improvement from baseline at all time points up to 6 months after treatment. Restylane was well tolerated, and no systemic reactions or other safety concerns were raised. Some mild, transient reactions were reported and resolved spontaneously without need of specific treatment. Xiaoqing Yan, M.D. Jun Xu, M.D. Division of Plastic Surgery Chinese People's Liberation Army General Hospital Changsheng Lu, M.D. Plastic Surgery Hospital Chinese Academy of Medical Sciences Yongguang Ma, M.D. Department of Plastic Surgery Peking University 3rd Hospital Wei Li, M.D. Division of Biometrics Clinical Pharmacology Center Fu Wai Hospital Chinese Academy of Medical Sciences Beijing, China

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Abstract

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