Efficacy of fluticasone propionate cream alone or in combination with calcipotriol ointment in the treatment of mild to moderate plaque psoriasis: a randomized self-controlled study / 中华皮肤科杂志

ABSTRACT

Objective:To evaluate short-term efficacy and safety of fluticasone propionate 0.05% cream alone or in combination with calcipotriol 0.005% ointment in the treatment of mild to moderate plaque psoriasis.Methods:From October 2020 to January 2021, a randomized, open-labeled, self-controlled clinical trial was conducted among 30 patients with mild to moderate plaque psoriasis in Beijing Friendship Hospital. Skin lesions on the extremity of one side were topically treated with calcipotriol 0.005% ointment in the morning and fluticasone propionate 0.05% cream in the evening (combination group) , and lesions on the contralateral extremity were topically treated with fluticasone propionate 0.05% cream twice a day (fluticasone propionate group) . The treatment lasted 4 weeks. Before and 1, 2, 4 weeks after the start of treatment, the patients were followed up, clinical indices including static physician′s global assessment (sPGA) and psoriasis area and severity index (PASI) were evaluated, and adverse events were recorded. Efficacy and safety were evaluated by using repeated measures analysis of variance, multivariate analysis of variance, Mann-Whitney rank sum test and two-independent-sample t test. Results:Before the treatment, there was no significant difference in sPGA or PASI score between the combination group and fluticasone propionate group (both P > 0.05) . After 1-week treatment, the fluticasone propionate group showed significantly decreased sPGA (1.10 ± 0.31 points) and PASI scores (1.05 ± 0.51 points) compared with the combination group (1.73 ± 0.45 points, 1.38 ± 0.69 points, F= 40.74, 4.38, respectively, both P < 0.05) ; after 2- and 4-week treatment, the combination group showed significantly decreased sPGA (0.83 ± 0.46 points, 0.23 ± 0.43 points, respectively) and PASI scores (0.53 ± 0.47 points, 0.23 ± 0.50 points, respectively) compared with the fluticasone propionate group (sPGA 1.03 ± 0.18 points, 0.97 ± 0.32 points, F= 4.88, 56.14, respectively, both P < 0.05; PASI 1.03 ± 0.51 points, 0.92 ± 0.54 points, F= 15.20, 26.36, respectively, both P < 0.05) . After 1-week treatment, the infiltration/hypertrophy severity score was significantly lower in the fluticasone propionate group than in the combination group ( U= 165.00, P < 0.05) ; after 2- and 4-week treatment, the erythema and scaling severity scores were significantly lower in the combination group than in the fluticasone propionate group (erythema U= 540.00, 765.00, respectively, both P < 0.05; scaling U= 825.00, 795.00, respectively, both P < 0.05) . Conclusion:Fluticasone propionate 0.05% cream alone exhibited a rapid onset of efficacy in the treatment of psoriasis, while fluticasone propionate 0.05% cream combined with calcipotriol 0.005% ointment was more effective after 2- and 4-week treatment, and both regimens showed a favorable safety profile.