title: Safety and Effectiveness of Juvéderm Ultra Plus Injectable Gel in Correcting Severe Nasolabial Folds in Chinese Subjects.
abstract: BACKGROUND
  Hyaluronic acid dermal fillers are effective in correcting severe nasolabial folds (NLFs) in non-Asian populations. We assessed safety and effectiveness of Juvéderm Ultra Plus in a Chinese population.
  
  
  METHODS
  This double-blind study randomized Chinese subjects with severe NLFs to Juvéderm Ultra Plus (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (0 is "no wrinkle" and 4 is "very deep wrinkle"). Investigator-assessed responder rates (primary outcome at 6 months), NLF mean improvements, and subject-assessed responder rates and preference were assessed.
  
  
  RESULTS
  Of 124 subjects randomized, 122 completed the 6-month visit. NLFs treated with Juvéderm Ultra Plus required less volume than those treated with Restylane (median [range]: 0.80 [0.3-2.0] vs 1.00 [0.3-1.9];P<0.001). Investigator-assessed responder rates were 90.4% for Juvéderm Ultra Plus and 89.6% for Restylane, establishing noninferiority of Juvéderm Ultra Plus. Mean (SD) improvements in NLF Severity Scale scores from baseline at 6 months were 1.5 (0.75) for Juvéderm Ultra Plus and 1.6 (0.73) for Restylane. Subject-assessed responder rates were similar to investigator-assessed rates (87.3%, Juvéderm Ultra Plus; 83.9%, Restylane). Of subjects reporting a preference, 62.1% preferred Juvéderm Ultra Plus. The most common treatment site responses were swelling and tenderness; most were mild or moderate in severity and resolved without intervention. Juvéderm Ultra Plus had fewer severe treatment site responses than Restylane.
  
  
  CONCLUSIONS
  In this study in Chinese subjects, Juvéderm Ultra Plus was safe and effective for correcting severe NLFs.
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Dong
authors.initials: D
authors.lastname: Li
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Yun
authors.initials: Y
authors.lastname: Xie
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Qin
authors.initials: Q
authors.lastname: Li
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Jiaming
authors.initials: J
authors.lastname: Sun
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Ping
authors.initials: P
authors.lastname: Jiang
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Yi
authors.initials: Y
authors.lastname: Jia
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Diane K
authors.initials: DK
authors.lastname: Murphy
authors.affiliation: Peking University Third Hospital, Beijing, China (D.L.); Shanghai 9th People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Y.X., Qingfeng Li); General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guang Dong, China (Qin Li); Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China (J.S.); Nanfang Hospital, Southern Medical University, Guangzhou, China (P.J.); Allergan China, Beijing, China (Y.J.); and Allergan plc, Irvine, Calif., (D.K.M.).
authors.forename: Qingfeng
authors.initials: Q
authors.lastname: Li