Background Becocalcidiol is a vitamin D3 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.