A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
| Autor: | Lin Cai, Gen-Hui Chen, Qian-Jin Lu, Min Zheng, Yu-Zhen Li, Jin Chen, Jie Zheng, Fu-Ren Zhang, Jian-Bin Yu, Sen Yang, Fu-Qiu Li, Sheng-Xiang Xiao, Qiu-Ning Sun, Jin-Hua Xu, Xing-Hua Gao, Hong Fang, Tian-Wen Gao, Fei Hao, Quan-Zhong Liu, Ya-Ting Tu, Ruo-Yu Li, Bao-Xi Wang, Dan-Qi Deng, Qing-Shan Zheng, Hong-Xia Liu, Jian-Zhong Zhang, Li-Shao Guo. |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: | |
| Zdroj: | Chinese Medical Journal, Vol 133, Iss 24, Pp 2905-2909 (2020) |
| Druh dokumentu: | article |
| ISSN: | 0366-6999 2542-5641 00000000 |
| DOI: | 10.1097/CM9.0000000000001221 |
| Popis: | Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P |
| Databáze: | Directory of Open Access Journals |
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