Long-term safety of topical calcitriol 3 mu g g(-1) ointment

To assess the topical and systemic safety and tolerance of twice-daily appl ication of 3 mug g(-1) 1 alpha 25-dihydroxyvitamin D-3 (calcitriol) ointmen t (Silkis ointment(R), Galderma Laboratories) in the longterm treatment of patients suffering from chronic plaque psoriasis. we performed an open-desi gn. multicentre study. Two hundred and fifty-three patients (155 males, 98 females) treated all their psoriatic lesions, except for those on the head and scalp, for up to 78 weeks. No serious adverse events were reported: 37 patients (14.6%) had a transient skin irritation reaction on one or more oc casions during the study that resulted in study withdrawal for seven of the m. The baseline/endpoint analyses showed no clinically relevant changes in measures of calcium and phosphorus homeostasis and renal function. Slight h ypercalcaemia was observed in five (2%) patients; in four of these patients , serum albumin-adjusted total calcium levels normalized during treatment. In conclusion, twice-daily calcitriol 3 mug g(-1) ointment is safe and well tolerated in the long-term treatment of chronic plaque psoriasis.