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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

  • Therapy
  • Published:
European Journal of Dermatology

Abstract

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.

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Author information

Authors and Affiliations

  1. Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

    Lunfei Liu & Min Zheng

  2. Peking University Third Hospital, Beijing, China

    Chunlei Zhang

  3. Ningbo No.2 Hospital, Ningbo, China

    Jinyan Wang

  4. Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China

    Kun Chen

  5. Shanghai Skin Disease Hospital, Shanghai, China

    Yangfeng Ding

  6. Chongqing Traditional Chinese Medicine Hospital, Chongqing, China

    Guofu Yan

  7. The Second Xiangya Hospital of Central South University, Changsha, China

    Qianjin Lu

  8. West China Hospital Sichuan University, Chengdu, China

    Wei Li

  9. The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China

    Hong Fang

  10. School of Medicine, Sir Run Run Shaw Hospital (SRRSH) Zhejiang University, Hangzhou, China

    Hao Cheng

  11. Peking University People’s Hospital, Beijing, China

    Jianzhong Zhang

  12. Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

    Yanling He

  13. Xuanwu Hospital Capital Medical University, Beijing, China

    Wei Zhu

  14. Jiangsu Province Hospital, Nanjing, China

    Yan Lu

  15. The Third Xiangya Hospital of Central South University, Changsha, China

    Jinhua Huang

  16. Zhejiang Provincial People’s Hospital, Hangzhou, China

    Weili Pan

  17. Fudan University Zhongshan Hospital, Shanghai, China

    Ming Li

  18. Affiliated Hospital of Nantong University, Nantong, China

    Shuanglin Cao

  19. The First Hospital of Jilin University, Changchun, China

    Shanshan Li

  20. Shengjing Hospital of China Medical University, Shenyang, China

    Xiuping Han

  21. First Affiliated Hospital of Kunming Medical University, Kunming, China

    Li He

  22. LEO Pharma A/S, Ballerup, Denmark

    Yayuan Chen

Authors
  1. Lunfei Liu
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  2. Chunlei Zhang
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  3. Jinyan Wang
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  4. Kun Chen
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  5. Yangfeng Ding
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  6. Guofu Yan
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  7. Qianjin Lu
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  8. Wei Li
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  9. Hong Fang
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  10. Hao Cheng
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  11. Jianzhong Zhang
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  12. Yanling He
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  13. Wei Zhu
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  14. Yan Lu
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  15. Jinhua Huang
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  16. Weili Pan
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  17. Ming Li
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  18. Shuanglin Cao
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  19. Shanshan Li
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  20. Xiuping Han
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  21. Li He
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  22. Yayuan Chen
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  23. Min Zheng
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Corresponding author

Correspondence to Min Zheng.

Additional information

Acknowledgements and disclosures

Acknowledgements: the authors thank the investigators who participated in this study. Johan Petter Soderstrom of LEO Pharma A/S is acknowledged for assistance with the preparation of this manuscript. Financial support: this trial was sponsored by LEO Pharma A/S, Ballerup, Denmark. Conflicts of interest: YY. Chen is a salaried employee of LEO Pharma A/S. All authors declare that they have no conflicts of interest.

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Liu, L., Zhang, C., Wang, J. et al. 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. Eur J Dermatol 30, 580–590 (2020). https://doi.org/10.1684/ejd.2020.3876

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  • DOI: https://doi.org/10.1684/ejd.2020.3876

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