Zheng Feng1, Qiuning Sun, Li He, Yan Wu, Hongfu Xie, Guang Zhao, Jinhua Xu, Chen Yao, Hengjin Li. 1. *Department of Dermatology, General Hospital of PLA, Beijing, China; †Department of Dermatology, Peking Union Medical College Hospital (PUMCH), Beijing, China; ‡Department of Dermatology, The First Affiliated Hospital of Kunming Medical University, Kunming, China; §Department of Dermatology, Peking University First Hospital, Beijing, China; ‖Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China; ¶Department of Dermatology, Air Force General Hospital, PLA, Beijing, China; #Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China; **Peking University Clinical Research Institute, Beijing, China.
Abstract
BACKGROUND: Various preparations of botulinum toxin type A (BTX-A) are used to reduces glabellar (frown) lines. However, dose-related safety and efficacy of intramuscular injections of a widely used, locally produced BTX-A in China has not been established. OBJECTIVE: Assessment of dose-dependent safety and efficacy of Chinese botulinum toxin type A (Hengli BTX-A [HBTX-A]) intramuscular injections on glabellar lines. METHODS:Four hundred eighty-eight BTX-A-naive participants were included in the double-blind trial and randomly divided into placebo (n = 122), low-dose (n = 183), and high-dose (n = 183) treatment groups for injection with saline solution, 10 units and 20 units of HBTX-A, respectively, at 4 sites in the corrugator muscle and 1 site in the procerus muscle. Outcomes were recorded before treatment and after 7, 30, 60, and 120 days, including glabellar line severity at maximum contraction and relaxation. RESULTS: Significantly greater improvement was observed in both HBTX-A groups in comparison with the placebo group (p < .05). Better efficacy was obtained in the high-dose treatment group. More participants developed adverse events after treatment with HBTX-A doses, than with the placebo (p < .05). CONCLUSION: Twenty-unit HBTX-A provided optimal improvement in glabellar lines, and its use might minimize injection frequency while maintaining acceptable safety.
RCT Entities:
BACKGROUND: Various preparations of botulinum toxin type A (BTX-A) are used to reduces glabellar (frown) lines. However, dose-related safety and efficacy of intramuscular injections of a widely used, locally produced BTX-A in China has not been established. OBJECTIVE: Assessment of dose-dependent safety and efficacy of Chinese botulinum toxin type A (Hengli BTX-A [HBTX-A]) intramuscular injections on glabellar lines. METHODS: Four hundred eighty-eight BTX-A-naive participants were included in the double-blind trial and randomly divided into placebo (n = 122), low-dose (n = 183), and high-dose (n = 183) treatment groups for injection with saline solution, 10 units and 20 units of HBTX-A, respectively, at 4 sites in the corrugator muscle and 1 site in the procerus muscle. Outcomes were recorded before treatment and after 7, 30, 60, and 120 days, including glabellar line severity at maximum contraction and relaxation. RESULTS: Significantly greater improvement was observed in both HBTX-A groups in comparison with the placebo group (p < .05). Better efficacy was obtained in the high-dose treatment group. More participants developed adverse events after treatment with HBTX-A doses, than with the placebo (p < .05). CONCLUSION: Twenty-unit HBTX-A provided optimal improvement in glabellar lines, and its use might minimize injection frequency while maintaining acceptable safety.
Authors: Cristina Pires Camargo; Jun Xia; Caroline S Costa; Rolf Gemperli; Maria Dc Tatini; Max K Bulsara; Rachel Riera Journal: Cochrane Database Syst Rev Date: 2021-07-05