Long-term safety of topical calcitriol 3 μg g⁻¹ ointment

Authors: Gerritsen, M.J.P.¹; van de Kerkhof, P.C.M.¹; Langner, A.²

Source: British Journal of Dermatology, Volume 144, Supplement 58, April 2001 , pp. 17-19(3)

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Abstract:

To assess the topical and systemic safety and tolerance of twice-daily application of 3 μg g⁻¹ 1α25-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 μg g⁻¹ ointment is safe and well tolerated in the long-term treatment of chronic plaque psoriasis.

Keywords: calcitriol; long-term; plaque psoriasis; safety; tolerance

Document Type: Research article

DOI: http://dx.doi.org/10.1046/j.1365-2133.2001.00035.x

Affiliations: 1: Department of Dermatology, University Hospital Nijmegen, PO Box 9101, 6500 HB Nijmegen, the Netherlands 2: Dermatology Department, Medical University of Warsaw, Poland

Publication date: 2001-04-01