Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled phase 4 trial

• Published in: EJD. European journal of dermatology 2020-10, Vol.30 (5), p.580-590
• Main Authors: Liu, Lunfei, Zhang, Chunlei, Wang, Jinyan, Chen, Kun, Ding, Yangfeng, Yan, Guofu, Lu, Qianjin, Li, Wei, Fang, Hong, Cheng, Hao, Zhang, Jianzhong, He, Yanling, Zhu, Wei, Lu, Yan, Huang, Jinhua, Pan, Weili, Li, Ming, Cao, Shuanglin, Li, Shanshan, Han, Xiuping, He, Li, Chen, Yayuan, Zheng, Min
• Format: Article
• Language: English
• Subjects: Dermatology; Medicine; Medicine & Public Health; Therapy
• ISSN: 1167-1122; 1952-4013
• DOI: 10.1684/ejd.2020.3876

Background The efficacy and safety of calcipotriol plus betamethasone dipropionate gel for the treatment of scalp psoriasis has previously been demonstrated in a four-week trial in a Chinese population. Objective To evaluate the long-term safety and efficacy of two-compound gel in Chinese adult patients with scalp psoriasis. Materials & Methods A multicentre, prospective, randomized, active-controlled trial was established in which subjects were randomized (at a ratio of 4: 1) to receive either two-compound gel once daily or calcipotriol scalp solution twice daily for 28 weeks. Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern associated with long-term corticosteroid use on the scalp were evaluated. Results A total of 951 subjects were randomly assigned to receive either two-compound gel ( n =760) or calcipotriol scalp solution ( n =191). The incidence of ADRs was significantly lower in the two-compound gel group compared with the calcipotriol scalp solution group (11.7 vs. 22.2%, p