Topical becocalcidiol for the treatment of psoriasis vulgaris: a randomized, placebo‐controlled, double‐blind, multicentre study

Summary Background  Becocalcidiol is a vitamin D 3 analogue which has not caused hypercalcaemia or significant irritation in preclinical trials. Objectives  To evaluate the efficacy and safety of two dosing regimens of becocalcidiol ointment (low dose = 75 μg g −1 once daily for 8 weeks; high dose = 75 μg g −1 twice daily for 8 weeks) in the treatment of plaque‐type psoriasis. Methods  One hundred and eighty‐five subjects with chronic plaque‐type psoriasis affecting 2–10% of their body surface area took part in a multicentre, double‐blind, parallel‐group, vehicle‐controlled, randomized controlled trial comparing topical application of placebo, becocalcidiol 75 μg g −1 once daily (low dose) or becocalcidiol twice daily (high dose) for 8 weeks. Main outcomes included Physician’s Static Global Assessment of Overall Lesion Severity (PGA) score; Psoriasis Symptom Severity (PSS) score; adverse events; and laboratory assessment. Results  In the intent‐to‐treat population at week 8, high‐dose becocalcidiol was statistically superior to vehicle [ P  = 0·002; 95% confidence interval (CI) 6·7–32·2], with 16 of 61 (26%) subjects achieving a PGA score of clear or almost clear. Greater improvement in PSS score was seen with high‐dose becocalcidiol than with vehicle, but this result did not quite achieve statistical significance ( P  = 0·052; 95% CI –16·2 to 0·1). In all groups, therapy was safe and well tolerated, with fewer subjects experiencing irritation than is reported in studies using calcipotriol. Conclusions  Treatment with high‐dose topical becocalcidiol for 8 weeks led to almost or complete clearing of moderate plaque‐type psoriasis in over a quarter of patients. Therapy was safe and well tolerated.