Evaluating the Safety of Calcipotriene 30 g Per Day in Patients with Psoriasis: A Parallel Group, Vehicle‐Controlled Study

Abstract

Elevated blood and urine calcium levels have been reported with the use of high doses of calcipotriene ointment in patients with psoriasis. The objective of this study was to evaluate key measures of calcium metabolism in patients with psoriasis under supervised dosing conditions in a vehicle-controlled study. Of the 24 patients enrolled, 12 each were administered 15 g of ointment containing calcipotriene or vehicle twice a day for 14 days. Blood and urine samples and 24-hour urine collections were obtained at selected time points. All 24 patients completed the study with no significant differences between treatments in any of the laboratory parameters. Trend analysis failed to show any significant differences over time with the exception of calcium, which showed significant changes common to both the calcipotriene and vehicle groups, suggesting that these changes were unrelated to treatment. The results of this study show that the use of calcipotriene ointment at a dose of 30 g per day for 14 days did not produce any significant alterations in blood or urine calcium concentrations and was well tolerated.

Evidence‐based recommendations on topical treatment and phototherapy of psoriasis: systematic review and expert opinion of a panel of dermatologists

“…Concerning safety, the research focused on hypercalcemia and skin atrophy. Safety was the main topic of seven articles 36–42 . No case of hypercalcemia was reported.…”

“…Safety was the main topic of seven articles. [36][37][38][39][40][41][42] No case of hypercalcemia was reported. Three other studies [43][44][45] reported transient hypercalcemia without any clinical implication, except in two patients for whom the topical vitamin D analogue was stopped.…”

Topical vitamin D analogues alone or in association with topical steroids for psoriasis: a systematic review

“…1). A total of 30 studies were performed in patients with plaque psoriasis, 19 studies evaluated VDS, 6–24 11 studies evaluated VD alone, 25–35 3 studies focused on quality of life, 8,36,37 7 studies focused on tolerability 10,38–43 . In addition nine studies on VD or VDS focused on scalp psoriasis, 44–52 two on VD focused on intertriginous psoriasis 53,54 …”

“…Safety was the main topic for seven studies 10,[38][39][40][41][42][43] and was also studied in 14 randomized controlled trials. Three studies focused on skin atrophy.…”

Safety and Efficacy of Combined High-Dose Treatment with Calcipotriol Ointment and Solution in Patients with Psoriasis

“…In a trial performed by Blum et al [11], 24 patients with moderate to extensive psoriasis were randomised to treatment with either 210 g calcipotriol ointment (50 µg/g) per week or the vehicle for 2 weeks without the induction of either hypercalcaemia or hypercalciuria.…”