The efficacy and safety of DermalaxTM DEEP in the correction of moderate to severe nasolabial folds: a multicenter, randomized, double-blind clinical study
机构:[1]Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Dermatol, 1 Shuaifuyuan, Beijing, Peoples R China[2]Capital Med Univ, Beijing Tongren Hosp, Dept Dermatol, Beijing, Peoples R China临床科室皮肤性病科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[3]Zhejiang Univ, Dept Dermatol, Med Sch, Affiliated Hosp 1, Hangzhou, Peoples R China浙江大学医学院附属第一医院[4]Sichuan Univ, Dept Dermatol, West China Hosp, Chengdu, Peoples R China四川大学华西医院[5]Shanghai Dermatol Hosp, Shanghai, Peoples R China[6]Chinese Acad Med Sci & Peking Union Med Coll, Inst Dermatol, Nanjing, Peoples R China[7]Zhejiang Univ, Med Sch, Affiliated Hosp 2, Dept Dermatol, Hangzhou, Peoples R China
Background: To investigate the efficacy and safety of Dermalax in the correction of moderate to severe nasolabial folds (NLFs) compared to Restylane. Methods: A total of 324 subjects with moderate to severe NLFs were enrolled in this multicenter, randomized, double-blind, active-controlled clinical study. Eligible subjects were randomly assigned to the test group received Dermalax injection (n = 162) or control group received Restylane injection (n = 162). Clinical efficacy and safety were assessed based on the Wrinkle Severity Rating Scale (WSRS) and the Global Esthetic Improvement Scale(GAIS) at weeks 2, 8, 16, 24, 36 and 48 weeks after injection. Results: At week 24, similar improvements of effective rate were obtained on the Dermalax group (93.75%) and Restylane group (89.44%). Significances were found at 36 weeks and 48 weeks after injection, Dermalax seemed be better than Restylane in maintaining the effect in the later period. The improvement of mean WSRS score for test group was superior to that of control group with significance. GAIS scores rated at week 24 were 1.65 VS 1.94 (p < .001) and 2.10 VS 2.27 (p = .060), seperately. Conclusions: Dermalax was no inferior to or better than that of the control filler Restylane in correcting of moderate to severe NLFs in Chinese subjects.
第一作者机构:[1]Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Dermatol, 1 Shuaifuyuan, Beijing, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
Qiao Ju,Li Feng,Jin Hong-Zhong,et al.The efficacy and safety of DermalaxTM DEEP in the correction of moderate to severe nasolabial folds: a multicenter, randomized, double-blind clinical study[J].JOURNAL OF DERMATOLOGICAL TREATMENT.2021,32(5):548-555.doi:10.1080/09546634.2019.1687814.
APA:
Qiao, Ju,Li, Feng,Jin, Hong-Zhong,Yang, Xiu-Min,Fang, Hong...&Jia, Qian-Nan.(2021).The efficacy and safety of DermalaxTM DEEP in the correction of moderate to severe nasolabial folds: a multicenter, randomized, double-blind clinical study.JOURNAL OF DERMATOLOGICAL TREATMENT,32,(5)
MLA:
Qiao, Ju,et al."The efficacy and safety of DermalaxTM DEEP in the correction of moderate to severe nasolabial folds: a multicenter, randomized, double-blind clinical study".JOURNAL OF DERMATOLOGICAL TREATMENT 32..5(2021):548-555