title: Calcitriol ointment 3 microg/g is safe and effective over 52 weeks for the treatment of mild to moderate plaque psoriasis.
abstract: Topical vitamin D3 agents have emerged as important options for the treatment of psoriasis. Calcitriol, a naturally occurring and biologically active form of vitamin D3, has been developed in an ointment formulation for topical psoriasis therapy in the United States. The product has been used outside of the United States for years. Several short-term (< 6 months) clinical trials have demonstrated that calcitriol ointment 3 microg/g improves symptoms of psoriasis in participants with mild to moderate plaque psoriasis without demonstrating clinical evidence of alterations in calcium homeostasis, but little information has been available about the safety and effectiveness of continuous long-term use of calcitriol ointment. In this open-label, multicenter study, 324 participants with primarily mild to moderate chronic plaque psoriasis were treated with calcitriol ointment 3 microg/g twice daily for up to 52 weeks. A total of 136 participants completed 52 weeks of treatment. Serious adverse events (AEs) (reported by 1 participant each unless otherwise noted) included a pretibial skin ulcer (study drug was used only on the upper body), a joint disorder, metrorrhagia (2 participants), heart failure, hospitalization due to arteriosclerosis, breast carcinoma, and an infection (due to a dog bite). Clinical improvement in psoriasis symptoms was assessed by an investigator-rated global severity score (GSS) and participant-rated global assessment of improvement in psoriasis symptoms from baseline. Improvements in GSS were seen over the course of treatment. Calcitriol ointment 3 microg/g is a safe, effective, and well-tolerated option for the long-term treatment of chronic plaque psoriasis. Clinical improvement was maintained for up to 52 weeks, with no clinical effect on calcium homeostasis or other relevant laboratory test parameters.
authors.affiliation: Mount Sinai School of Medicine, New York, NY 10029, USA. lebwohl@aol.com
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Ortonne
authors.forename: Philippe
authors.initials: P
authors.lastname: Andres
authors.forename: Philippe
authors.initials: P
authors.lastname: Briantais
mesh_terms: D000293:Adolescent; D002117:Calcitriol / Q000008:administration & dosage*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy*; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D009824:Ointments; D014815:Vitamins; D002117:Calcitriol