Evaluating the safety of calcipotriene 30 g per day in patients with psoriasis: a parallel group, vehicle-controlled study.
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.
Blum
R
R
Clinical Pharmacokinetics Laboratory, Millard Fillmore Hospital, Buffalo, New York, USA.
Schwartzel
E
E
Siskin
S
S
Epinette
W W
WW
D000328:Adult; D000368:Aged; D002117:Calcitriol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002118:Calcium / Q000097:blood / Q000652:urine; D003879:Dermatologic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000097:blood* / Q000188:drug therapy / Q000652:urine*
D003879:Dermatologic Agents; D009824:Ointments; C055085:calcipotriene; D002117:Calcitriol; D002118:Calcium