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.

• Authors: M J Gerritsen, P C Van De Kerkhof, A Langner
• Journal: The British journal of dermatology (Br J Dermatol) Vol. 144 Suppl 58 Pg. 17-9 (Apr 2001) ISSN: 0007-0963 [Print] England
• PMID: 11501508 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Anti-Inflammatory Agents
• Calcitriol

Topics

• Administration, Cutaneous
• Administration, Topical
• Adult
• Anti-Inflammatory Agents (adverse effects, therapeutic use)
• Calcitriol (adverse effects, therapeutic use)
• Chronic Disease
• Drug Administration Schedule
• Female
• Humans
• Male
• Psoriasis (drug therapy)
• Treatment Outcome