Calcipotriol betamethasone ointment in the treatment of psoriasis vulgaris: a randomized, double-blind, active-controlled, parallel group study.

Objective To assess the clinical efficacy and safety of calcipotriol betamethasone ointment （Daivobet ） in Chinese patients with stable psoriasis vulgaris. Methods In this double-blind, active-controlled, parallel group study, 320 patients were recruited from 4 clinical centers, and randomly divided into two groups to receive either calcipotriol betamethasone ointment once daily in the evening and placebo once daily in the morning or calcipotriol ointment twice daily. The safety and efficacy of the two regimens were evaluated on week 1, 2 and 4 after the first dosage. Results After 1 and 4 weeks of treatment, calcipotriol betamethasone-treated patients experienced a greater decrease in psoriasis area and severity index （PASI） compared with calcipotriol-treated patients （41.47%±18.21% vs 33.74% ± 16.94%, 79.23%±17.82% vs 70.43%±20.76%, respectively, both P 〈 0.001）. After 4 weeks of treatment, a 75 percent decrease in PASI was observed in 111 （73.03%） patients receiving combination therapy and 72 （48.32%） patients receiving monotherapy with significant difference between the two groups （P 〈 0.01 ）. A greater improvement was also seen in the individual score of redness, thickness, scaliness as well as area percentage of lesions at the end of week 1, 2 and 4 in patients receiving combination therapy than in patients receiving monotherapy （P 〈 0.05 or 0.01 ）. Of the 320 subjects, 58 （18.1%） reported adverse events and 42 （13.1%） reported drug-related adverse events. No statistical difference was observed in the incidence of adverse events （15.6% vs 20.6%, P 〉 0.05 ） or drug-related events （10.6% vs 15.6%, P 〉 0.05） between the two groups. Drug-related adverse events mainly included mild to moderate skin reactions, such as pruritus, folliculitis, erythema, etc. Conclusions Once daily calcipotriol betamethasone ointment is an effective, safe, convenient treatment with a rapid onset of action for stable psoriasis vulgaris in Chinese patients. Key words: Psoriasis;  Calcipotriol;  Betamethasone;  Randomized controlled trials