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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.

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机构： [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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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. To evaluate the long-term safety and efficacy of two-compound gel in Chinese adult patients with scalp psoriasis. 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. 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. The two-compound gel was well tolerated and effective in the long-term management of scalp psoriasis in Chinese patients.

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出版当年[2021]版：

大类 | 3 区医学

小类 | 3 区皮肤病学

最新[2023]版：

大类 | 4 区医学

小类 | 4 区皮肤病学

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出版当年[2020]版：

Q2 DERMATOLOGY

最新[2023]版：

Q3 DERMATOLOGY

影响因子： 2 最新[2023版] 2.6 最新五年平均 3.328 出版当年[2020版] 3.778 出版当年五年平均 2.782 出版前一年[2019版] 2.805 出版后一年[2021版]

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第一作者机构： [1]Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

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