Abstract: 【Abstract】 Objective To preliminarily evaluate clinical efficacy and safety of tazarotene 0.05%/betamethasone dipropionate 0.05% cream in the treatment of psoriasis vulgaris. Methods A multicenter, randomized, double-blinded, single-dummy, parallel-controlled clinical trial was conducted. Subjects with mild to moderate psoriasis vulgaris were randomized into 4 groups at a ratio of 2∶1∶1∶1, including tazarotene 0.05%/betamethasone dipropionate 0.05% cream （Taz/Bp） group, betamethasone dipropionate 0.05% cream （Bp） group, tazarotene 0.05% gel （Taz） group and cream vehicle control （Plb） group. The treatment lasted 4 weeks. After 1, 2 and 4 weeks of treatment, efficacy and safety of drugs were evaluated in the above groups. Two-way analysis of variance model with main effects was used to compare continuous indices, least significant difference t-test was used for multiple comparisons, and chi-square test or Fisher′s exact test for comparisons of categorical data. Results A total of 300 subjects were enrolled from 7 research centers, including 120 in the Taz/Bp group, 60 in the Bp group, 60 in the Taz group and 60 in the Plb group. After 4 weeks of treatment, proportions of patients achieving a 75% reduction in PASI （PASI75） were 35.83%, 20.00%, 18.33% and 6.67% in the Taz/Bp, Bp, Taz and Plb groups respectively, and there was a significant difference among the 4 groups （P < 0.05）; the proportion of patients achieving PASI75 was significantly higher in the Taz/Bp group than in the Plb group （α = 0.05, P < 0.05） and Taz group （α = 0.025, P < 0.025）, but there was no significant difference between the Taz/Bp group and Bp group （α = 0.016 7, P > 0.016 7）; the proportions of patients achieving PASI90 were 25.00%, 8.33%, 5.00% and 1.67% in the Taz/Bp, Bp, Taz and Plb groups respectively, which significantly differed among the 4 groups （P < 0.05）, and the Taz/Bp group showed a significantly increased proportion of patients achieving PASI90 compared with the Plb group （P < 0.05）, Taz group （P < 0.025）and Bp group （P < 0.016 7）. All the tested drugs were well tolerated in the 4 groups. Adverse drug reactions occurred in 15 （12.50%）, 5 （8.33%）, 19 （31.67%）and 9 （15.00%） patients in the Taz/Bp, Bp, Taz and Plb groups respectively. The incidence rate of adverse drug reactions significantly differed among the 4 groups （P = 0.004）, and was significantly lower in the Taz/Bp group than in the Taz group （P < 0.05）, but insignificantly different between the Taz/Bp group and Bp or Plb group （both P > 0.05）. Conclusion Tazarotene 0.05%/betamethasone dipropionate 0.05% cream is effective and safe for the treatment of psoriasis vulgaris.

Key words: Psoriasis, Betamethasone, Randomized controlled trial, Tazarotene/betamethasone dipropionate cream