TY - JOUR
T1 - Topical becocalcidiol for the treatment of psoriasis vulgaris
T2 - A randomized, placebo-controlled, double-blind, multicentre study
AU - Helfrich, Y. R.
AU - Kang, S.
AU - Hamilton, T. A.
AU - Voorhees, J. J.
PY - 2007/8
Y1 - 2007/8
N2 - 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.
AB - 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.
KW - Becocalcidiol
KW - Calcipotriol
KW - Psoriasis vulgaris
KW - Randomized controlled trial
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U2 - 10.1111/j.1365-2133.2007.08037.x
DO - 10.1111/j.1365-2133.2007.08037.x
M3 - Article
C2 - 17596167
AN - SCOPUS:34447530674
SN - 0007-0963
VL - 157
SP - 369
EP - 374
JO - British Journal of Dermatology
JF - British Journal of Dermatology
IS - 2
ER -