A LONG-TERM MULTICENTER ASSESSMENT OF THE SAFETY AND TOLERABILITY OF CALCITRIOL OINTMENT IN THE TREATMENT OF CHRONIC PLAQUE PSORIASIS

Calcitriol 1 alpha,25-dihydroxyvitamin D-3), applied topically in an o intment base, has been shown to be effective in the treatment of chron ic plaque psoriasis. This open study was designed to assess the safety and tolerability of 3 mu g/g calcitriol ointment applied twice daily over treatment periods of up to 78 weeks, In the 253 evaluable patient s with chronic plaque psoriasis no clinically relevant changes were ob served in the baseline/end-point analyses of mean serum levels of tota l calcium, albumin-adjusted total calcium, phosphorus and creatinine, and plasma calcitriol levels. Mean values of 24-h urinary calcium, pho sphorus, creatinine and hydroxyproline excretions, creatinine clearanc e and mean urinary calcium/creatinine ratio also did not show clinical ly relevant changes in the baseline/ end-point analyses, The treatment was well tolerated, with no serious adverse events occurring during t he course of the study, Eight patients withdrew from the study due to adverse events which, although not serious, were thought to be treatme nt-related: in seven patients skin irritation reactions and in one cas e a transient asymptomatic slight hypercalcaemia was observed, In addi tion, assessments of global severity, global improvement and Psoriasis Area and Severity Index scores confirmed the therapeutic efficacy of twice ally 3 mu g/g calcitriol ointment demonstrated in an earlier con trolled study, In conclusion, this study demonstrated that twice daily application of 3 mu g/g calcitriol ointment is safe and well-tolerate d in the treatment of chronic plaque psoriasis.