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

Abstract

To assess the topical and systemic safety and tolerance of twice-daily application of 3 microg g(-1) 1alpha25-dihydroxyvitamin D3 (calcitriol) ointment (Silkis ointment, Galderma Laboratories) in the long-term treatment of patients suffering from chronic plaque psoriasis, we performed an open-design, 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 occasions during the study that resulted in study withdrawal for seven of them. The baseline/endpoint analyses showed no clinically relevant changes in measures of calcium and phosphorus homeostasis and renal function. Slight hypercalcaemia 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 microg g(-1) ointment is safe and well tolerated in the long-term treatment of chronic plaque psoriasis.