PMID- 33052103 OWN - NLM STAT- MEDLINE DCOM- 20210901 LR - 20221207 IS - 1952-4013 (Electronic) IS - 1167-1122 (Linking) VI - 30 IP - 5 DP - 2020 Oct 1 TI - 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. PG - 580-590 LID - 10.1684/ejd.2020.3876 [doi] AB - 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. FAU - Liu, Lunfei AU - Liu L AD - Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Zhang, Chunlei AU - Zhang C AD - Peking University Third Hospital, Beijing, China. FAU - Wang, Jinyan AU - Wang J AD - Ningbo No.2 Hospital, Ningbo, China. FAU - Chen, Kun AU - Chen K AD - Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China. FAU - Ding, Yangfeng AU - Ding Y AD - Shanghai Skin Disease Hospital, Shanghai, China. FAU - Yan, Guofu AU - Yan G AD - Chongqing Traditional Chinese Medicine Hospital, Chongqing, China. FAU - Lu, Qianjin AU - Lu Q AD - The Second Xiangya Hospital of Central South University, Changsha, China. FAU - Li, Wei AU - Li W AD - West China Hospital Sichuan University, Chengdu, China. FAU - Fang, Hong AU - Fang H AD - The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China. FAU - Cheng, Hao AU - Cheng H AD - Sir Run Run Shaw Hospital (SRRSH) Zhejiang University, School of Medicine, Hangzhou, China. FAU - Zhang, Jianzhong AU - Zhang J AD - Peking University People's Hospital, Beijing, China. FAU - He, Yanling AU - He Y AD - Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. FAU - Zhu, Wei AU - Zhu W AD - Xuanwu Hospital Capital Medical University, Beijing, China. FAU - Lu, Yan AU - Lu Y AD - Jiangsu Province Hospital, Nanjing, China. FAU - Huang, Jinhua AU - Huang J AD - The Third Xiangya Hospital of Central South University, Changsha, China. FAU - Pan, Weili AU - Pan W AD - Zhejiang Provincial People's Hospital, Hangzhou, China. FAU - Li, Ming AU - Li M AD - Fudan University Zhongshan Hospital, Shanghai, China. FAU - Cao, Shuanglin AU - Cao S AD - Affiliated Hospital of Nantong University, Nantong, China. FAU - Li, Shanshan AU - Li S AD - The First Hospital of Jilin University, Changchun, China. FAU - Han, Xiuping AU - Han X AD - Shengjing Hospital of China Medical University, Shenyang, China. FAU - He, Li AU - He L AD - First Affiliated Hospital of Kunming Medical University, Kunming, China. FAU - Chen, Yayuan AU - Chen Y AD - LEO Pharma A/S, Ballerup, Denmark. FAU - Zheng, Min AU - Zheng M AD - Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. LA - eng PT - Clinical Trial, Phase IV PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - France TA - Eur J Dermatol JT - European journal of dermatology : EJD JID - 9206420 RN - 0 (Anti-Inflammatory Agents) RN - 0 (Dermatologic Agents) RN - 0 (Gels) RN - 0 (Solutions) RN - 143NQ3779B (calcipotriene) RN - 826Y60901U (betamethasone-17,21-dipropionate) RN - 9842X06Q6M (Betamethasone) RN - FXC9231JVH (Calcitriol) SB - IM MH - Adult MH - Aged MH - Anti-Inflammatory Agents/adverse effects/*therapeutic use MH - Asian People MH - Betamethasone/adverse effects/*analogs & derivatives/therapeutic use MH - Calcitriol/adverse effects/*analogs & derivatives/therapeutic use MH - Dermatologic Agents/adverse effects/*therapeutic use MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Female MH - Gels MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Psoriasis/*drug therapy/ethnology MH - Scalp Dermatoses/*drug therapy/ethnology MH - Solutions MH - Treatment Outcome OTO - NOTNLM OT - Chinese OT - calcipotriol plus betamethasone dipropionate gel OT - calcipotriol scalp solution OT - long-term OT - safety OT - scalp psoriasis EDAT- 2020/10/15 06:00 MHDA- 2021/09/02 06:00 CRDT- 2020/10/14 12:43 PHST- 2020/10/15 06:00 [pubmed] PHST- 2021/09/02 06:00 [medline] PHST- 2020/10/14 12:43 [entrez] AID - ejd.2020.3876 [pii] AID - 10.1684/ejd.2020.3876 [doi] PST - ppublish SO - Eur J Dermatol. 2020 Oct 1;30(5):580-590. doi: 10.1684/ejd.2020.3876.