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

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 pati...

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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
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Language:English
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Dermatology
Medicine
Medicine & Public Health
Therapy
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container_title EJD. European journal of dermatology
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creator 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
description 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
doi_str_mv 10.1684/ejd.2020.3876
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Objective To evaluate the long-term safety and efficacy of two-compound gel in Chinese adult patients with scalp psoriasis. Materials &amp; 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 &lt;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.</description><identifier>ISSN: 1167-1122</identifier><identifier>EISSN: 1952-4013</identifier><identifier>DOI: 10.1684/ejd.2020.3876</identifier><language>eng</language><publisher>Paris: John Libbey Eurotext</publisher><subject>Dermatology ; Medicine ; Medicine &amp; Public Health ; Therapy</subject><ispartof>EJD. 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European journal of dermatology</title><addtitle>Eur J Dermatol</addtitle><description>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 &amp; 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 &lt;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. 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European journal of dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Liu, Lunfei</au><au>Zhang, Chunlei</au><au>Wang, Jinyan</au><au>Chen, Kun</au><au>Ding, Yangfeng</au><au>Yan, Guofu</au><au>Lu, Qianjin</au><au>Li, Wei</au><au>Fang, Hong</au><au>Cheng, Hao</au><au>Zhang, Jianzhong</au><au>He, Yanling</au><au>Zhu, Wei</au><au>Lu, Yan</au><au>Huang, Jinhua</au><au>Pan, Weili</au><au>Li, Ming</au><au>Cao, Shuanglin</au><au>Li, Shanshan</au><au>Han, Xiuping</au><au>He, Li</au><au>Chen, Yayuan</au><au>Zheng, Min</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>EJD. European journal of dermatology</jtitle><stitle>Eur J Dermatol</stitle><date>2020-10-01</date><risdate>2020</risdate><volume>30</volume><issue>5</issue><spage>580</spage><epage>590</epage><pages>580-590</pages><issn>1167-1122</issn><eissn>1952-4013</eissn><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 &amp; 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 &lt;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.</abstract><cop>Paris</cop><pub>John Libbey Eurotext</pub><doi>10.1684/ejd.2020.3876</doi><tpages>11</tpages></addata></record>
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subjects Dermatology
Medicine
Medicine & Public Health
Therapy
title 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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