Efficacy of tazarotene 0.05%/betamethasone dipropionate 0.05% cream in the treatment of mild to moderate psoriasis vulgaris: a multicenter clinical observational study / 中华皮肤科杂志

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.