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

Calcitriol (1 alpha,25-dihydroxyvitamin D-3) ointment has been shown t o be effective in the treatment of chronic plaque psoriasis, The prese nt 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 253 evaluable patients with chronic plaque psori asis no clinically relevant changes were observed in the baseline/endp oint analyses of any laboratory tests, including measurements of calci um homeostasis such as serum levels of total calcium, albumin-adjusted total calcium and phosphorus and plasma calcitriol levels, The treatm ent was well tolerated with no serious adverse events occurring during the course of the study, Eight patients withdrew due to adverse event s which, though not serious, were thought to be treatment related: sev en patients showed skin irritation reactions and in one case a mild, t ransient, asymptomatic hypercalaemia was observed, Assessments of glob al severity, global improvement and Psoriasis Area and Severity Index (PASI) scores confirmed the therapeutic efficacy demonstrated in earli er studies, In conclusion, the twice daily application of 3 mu g/g cal citriol ointment was safe, well tolerated and effective in the long-te rm treatment of chronic plaque psoriasis, and did not affect systemic calcium metabolism during prolonged treatment.