John Libbey Eurotext

European Journal of Dermatology


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 Volume 30, numéro 5, September-October 2020


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1 Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
2 Peking University Third Hospital, Beijing, China
3 Ningbo No.2 Hospital, Ningbo, China
4 Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China
5 Shanghai Skin Disease Hospital, Shanghai, China
6 Chongqing Traditional Chinese Medicine Hospital, Chongqing, China
7 The Second Xiangya Hospital of Central South University, Changsha, China
8 West China Hospital Sichuan University, Chengdu, China
9 The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
10 Sir Run Run Shaw Hospital (SRRSH) Zhejiang University, School of Medicine, Hangzhou, China
11 Peking University People's Hospital, Beijing, China
12 Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
13 Xuanwu Hospital Capital Medical University, Beijing, China
14 Jiangsu Province Hospital, Nanjing, China
15 The Third Xiangya Hospital of Central South University, Changsha, China
16 Zhejiang Provincial People's Hospital, Hangzhou, China
17 Fudan University Zhongshan Hospital, Shanghai, China
18 Affiliated Hospital of Nantong University, Nantong, China
19 The First Hospital of Jilin University, Changchun, China
20 Shengjing Hospital of China Medical University, Shenyang, China
21 First Affiliated Hospital of Kunming Medical University, Kunming, China
22 LEO Pharma A/S, Ballerup, Denmark
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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<0.001). There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups. A statistically significant difference in the percentage of visits with treatment success according to the Subject's Global Assessment was observed (p=0.009); more subjects had visits with 100% treatment success (15.2 vs. 6.3%) and fewer subjects had visits with 0% treatment success (23.7 vs. 30.8%) using two-compound gel compared to calcipotriol scalp solution. Conclusion: The two-compound gel was well tolerated and effective in the long-term management of scalp psoriasis in Chinese patients.