Objective: To assess the systemic safety of calcitriol 3 microg/g ointment (Silkis) ointment) in relation to body surface area (BSA) affected by chronic plaque psoriasis.
Methods: In this open-label, multicentre study, patients were divided into three parallel groups: 5% to <15% (n=23), 15% to <25% (n=18), 25% to 35% (n=18) based on BSA involvement. Ointment was applied topically twice daily for 12 weeks; patients were followed up for a further 8 weeks.
Results: There was no alteration of calcium homeostasis: the mean values of albumin-adjusted serum total calcium, as well as 24-hour urinary calcium and serum calcitriol levels, remained within normal ranges throughout treatment. No changes in calcium or phosphate homeostasis related to the area of psoriasis being treated with calcitriol ointment were detected.
Conclusions: Reductions in the global severity score and BSA involvement, as well as results of the assessment of improvement, attested to the clinical efficacy of calcitriol 3 microg/g ointment in psoriasis. The study confirms the systemic safety of calcitriol 3 microg/g in psoriatic patients with 5-35% BSA involvement.