Efficacy of tazarotene/betamethasone dipropionate cream at different concentration ratios in the treatment of psoriasis vulgaris: a clinical observation
- VernacularTitle:不同浓度配比的他扎罗汀倍他米松乳膏治疗寻常型银屑病的疗效观察
- Author:
Hao CHEN
1
;
Haizhen YANG
;
Jun GU
;
Hai WEN
;
Ming LI
;
Xiaoming LIU
;
Fei HAO
;
Donghua LOU
;
Jianfang SUN
Author Information
- From: Chinese Journal of Dermatology 2020;53(5):330-334
- CountryChina
- Language:Chinese
- Abstract: Objective:To evaluate the efficacy and safety of tazarotene/betamethasone dipropionate cream at different concentration ratios in the treatment of psoriasis vulgaris, and to determine the optimal drug concentration ratio for clinical use.Methods:A multicenter, randomized, double-blinded, multi-dose controlled study was conducted. From December 2008 to April 2009, a total of 180 patients with psoriasis vulgaris were enrolled from 7 research centers, such as Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College. These patients were randomly and equally divided into 5 groups: treatment groups 1, 2, 3, 4 treated with tazarotene/betamethasone dipropionate cream at concentration ratios of 0.025%/0.025%, 0.05%/0.025%, 0.025%/0.05% and 0.05%/0.05% respectively once a day, and control group treated with the cream vehicle once a day. The treatment lasted 4 weeks. Efficacy and safety were evaluated after 1, 2 and 4 weeks of treatment. One-way analysis of variance and least significant difference (LSD)- t test were used to compare measurement data among several groups, chi-square test and Fisher′s exact test to compare categorical data among groups, and Cochran-Mantel-Haenszel (CMH) test to compare psoriasis area severity index (PASI) response rates between groups. Results:After 4 weeks of treatment, 11 patients (30.56%) , 12 (33.33%) , 12 (33.33%) , 19 (52.78%) and 2 (5.56%) in the treatment groups 1, 2, 3, 4 and control group respectively achieved a 75% reduction in PASI (PASI75) , and the proportions of patients achieving PASI75 were significantly higher in the treatment groups than in the control group (all P < 0.012 7) . Additionally, the proportions of patients achieving PASI90 were also significantly higher in the treatment groups 1, 2 and 4 than in the control group (all P < 0.012 7) . After 4 weeks of treatment, the rates of reduction in PASI scores were 59.52% ± 26.79%, 57.19% ± 31.98%, 56.85% ± 30.46% and 68.21% ± 37.20% in treatment groups 1, 2, 3, and 4 respectively, which were all significantly higher than the rate of reduction in the control group (20.07% ± 28.55%; LSD- t = 5.36, 5.05, 5.00, 6.55, all P < 0.001) . The treatment group 4 showed marked comprehensive efficacy. All the tested drugs were well tolerated in the patients, and adverse reactions occurred in 11 (30.56%) , 8 (22.22%) , 2 (5.56%) , 4 (11.11%) and 2 (5.56%) cases in the treatment groups 1, 2, 3, 4 and control group respectively. The incidence rate of adverse reactions was significantly higher in the treatment group 1 than in the control group ( P = 0.012) , and there was no significant difference among the treatment groups 2, 3, 4 and control group (all P > 0.05) . Conclusion:The tazarotene 0.05%/betamethasone dipropionate 0.05% cream can be recommended for subsequent clinical trials in psoriasis vulgaris.
