A long-term multicentre assessment of the safety and tolerability of calcitriol ointment in the treatment of chronic plaque psoriasis.

Calcitriol (1 alpha,25-dihydroxyvitamin D3), applied topically in an ointment base, has been shown to be effective in the treatment of chronic plaque psoriasis. This open study was designed to assess the safety and tolerability of 3 micrograms/g calcitriol ointment applied twice daily over treatment periods of up to 78 weeks. In the 253 evaluable patients with chronic plaque psoriasis no clinically relevant changes were observed in the baseline/end-point analyses of mean serum levels of total calcium, albumin-adjusted total calcium, phosphorus and creatinine, and plasma calcitriol levels. Mean values of 24-h urinary calcium, phosphorus, creatinine and hydroxyproline excretions, creatinine clearance and mean urinary calcium/creatinine ratio also did not show clinically relevant changes in the baseline/end-point analyses. The treatment was well tolerated, with no serious adverse events occurring during the course of the study. Eight patients withdrew from the study due to adverse events which, although not serious, were thought to be treatment-related: in seven patients skin irritation reactions and in one case a transient asymptomatic slight hypercalcaemia was observed. In addition, assessments of global severity, global improvement and Psoriasis Area and Severity Index scores confirmed the therapeutic efficacy of twice daily 3 micrograms/g calcitriol ointment demonstrated in an earlier controlled study. In conclusion, this study demonstrated that twice daily application of 3 micrograms/g calcitriol ointment is safe and well-tolerated in the treatment of chronic plaque psoriasis.